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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01920711
Registration number
NCT01920711
Ethics application status
Date submitted
8/08/2013
Date registered
12/08/2013
Titles & IDs
Public title
Efficacy and Safety of LCZ696 Compared to Valsartan, on Morbidity and Mortality in Heart Failure Patients With Preserved Ejection Fraction
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Scientific title
A Multicenter, Randomized, Double-blind, Parallel Group, Active-controlled Study to Evaluate the Efficacy and Safety of LCZ696 Compared to Valsartan, on Morbidity and Mortality in Heart Failure Patients (NYHA Class II-IV) With Preserved Ejection Fraction (PARAGON-HF)
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Secondary ID [1]
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2013-001747-31
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Secondary ID [2]
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CLCZ696D2301
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Universal Trial Number (UTN)
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Trial acronym
PARAGON-HF
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Heart Failure With Preserved Ejection Fraction
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Condition category
Condition code
Cardiovascular
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Coronary heart disease
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Cardiovascular
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Other cardiovascular diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - LCZ696
Treatment: Drugs - Valsartan
Experimental: LCZ696 - Single Blind Run-in Period (3-8 weeks): Patients will start on Valsartan 80 mg b.i.d. for 1-2 weeks followed by LCZ696 100 mg b.i.d. for 2-4 weeks prior to randomization into the Double Blind period (up to 57 months). Patients can only be randomized from the run-in period if they meet all of the run-in safety criteria. Target dose of LCZ696 during the double blind period is 200 mg b.i.d.
Active comparator: Valsartan - Single Blind Run-in Period (3-8 weeks): Patients will start on Valsartan 80 mg b.i.d. for 1-2 weeks followed by LCZ696 100 mg b.i.d. for 2-4 weeks prior to randomization into the Double Blind period (up to 57 months). Patients can only be randomized from the run-in period if they meet all of the run-in safety criteria. Target dose of Valsartan during the double blind period is 160 mg b.i.d.
Treatment: Drugs: LCZ696
LCZ696 50mg, 100mg and 200 mg dosage strengths will be available for dose adjustments.
Treatment: Drugs: Valsartan
Valsartan 40mg, 80mg and 160mg dosage strengths will be available for dose adjustments.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Cumulative Number of Primary Composite Events of Cardiovascular (CV) Death and Total (First and Recurrent) HF Hospitalizations.
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Assessment method [1]
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The primary objective of this study is to compare LCZ696 to valsartan in reducing the rate of the composite endpoint of CV death and total (first and recurrent) HF hospitalizations, in HF patients (New York Heart Association \[NYHA\] Class II-IV) with preserved ejection fraction (left ventricular ejection fraction \[LVEF\] =45%). The treatment arm with the lower rate of events will be deemed as having a successful response.
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Timepoint [1]
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Total follow up time (up to 57 months)
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Secondary outcome [1]
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Change in the Clinical Summary Score From Baseline to Month 8 by Kansas City Cardiomyopathy Questionnaire (KCCQ)
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Assessment method [1]
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The KCCQ is a validated instrument for self-assessment of quality of life and health status in heart failure (HF) patients. The clinical summary score, which is derived from the physical limitations and heart failure (HF) symptoms domains of the KCCQ is a valid measure for assessing the patient's health aspects that may be influenced by CV medications. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. Evaluation of change from baseline to month 8 in KCCQ a most sensitive, specific, and responsive health-related quality of life measure for heart failure symptoms and physical limitations.
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Timepoint [1]
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Baseline, 8 months
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Secondary outcome [2]
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Change From Baseline to Month 8 in New York Heart Association (NYHA) Functional Class
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Assessment method [2]
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Evaluation of change from baseline to Month 8 in NYHA functional class, a well established grading scale used to classify a heart failure's (HF) patients' level of functionality based on the signs and symptoms of HF exhibited by the patient.
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Timepoint [2]
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Baseline, 8 months
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Secondary outcome [3]
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Participants With First Occurrence of a Composite Renal Endpoint
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Assessment method [3]
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Analyis of composite renal endpoint defined as renal death, or reaching ESRD, or =50% decline in eGFR relative to baseline, using Cox's proportional hazards model.
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Timepoint [3]
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Randomization to total follow-up time (up to 57 months)
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Secondary outcome [4]
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All-cause Mortality
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Assessment method [4]
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Analysis for all-cause mortality using Cox's proportional hazards model.
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Timepoint [4]
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Randomization to total follow up time (up to 57 months)
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Eligibility
Key inclusion criteria
* Left ventricular ejection fraction (LVEF) =45% by echo during screening epoch or within 6 months prior to study entry.
* Symptom(s) of heart failure (HF) and requiring treatment with diuretic(s) for HF at least 30 days prior to study entry.
* Current symptom(s) of HF (NYHA class II-IV)
* Structural heart disease (left atrial enlargement or left ventricular hypertrophy) documented by echocardiogram.
* Elevated NT-proBNP
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Minimum age
50
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Any prior measurement of LVEF < 40%.
* Acute coronary syndrome (including MI), cardiac surgery, other major CV surgery within 3 months , or urgent percutaneous coronary intervention within 3 months or and elective PCI within 30 days prior to entry.
* Any clinical event within the 6 months prior to entry could have reduced the LVEF (e.g., MI, CABG), unless an echo measurement performed after the event confirms a LVEF =45%.
* Current acute decompensated HF requiring therapy.
* Patients who require treatment with 2 or more of the following: an angiotensin converting enzyme inhibitor (ACEI), an angiotensin receptor blocker (ARB) or a renin inhibitor.
* Alternative reason for shortness of breath such as: significant pulmonary disease or severe COPD, hemoglobin (Hgb) <10 g/dl, or body mass index (BMI) > 40 kg/m2.
* Systolic blood pressure (SBP) = 180 mmHg at entry, or SBP >150 mmHg and <180 mmHg at entry unless the patient is receiving 3 or more antihypertensive drugs, or SBP < 110 mmHg at entry.
Other protocol-defined inclusion/exclusion criteria may apply.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
18/07/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
7/06/2019
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Sample size
Target
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Accrual to date
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Final
4822
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Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC
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Novartis Investigative Site - Southport
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4215 - Southport
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5041 - Bedford Park
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3083 - Bundoora
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3076 - Epping
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3220 - Geelong
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Zagreb
Query!
Country [121]
0
0
Czechia
Query!
State/province [121]
0
0
Czech Republic
Query!
Country [122]
0
0
Czechia
Query!
State/province [122]
0
0
CZE
Query!
Country [123]
0
0
Czechia
Query!
State/province [123]
0
0
Kolin
Query!
Country [124]
0
0
Czechia
Query!
State/province [124]
0
0
Marianske lazne
Query!
Country [125]
0
0
Czechia
Query!
State/province [125]
0
0
Uherske Hradiste
Query!
Country [126]
0
0
Denmark
Query!
State/province [126]
0
0
Esbjerg
Query!
Country [127]
0
0
Denmark
Query!
State/province [127]
0
0
Glostrup
Query!
Country [128]
0
0
Denmark
Query!
State/province [128]
0
0
Herlev
Query!
Country [129]
0
0
Denmark
Query!
State/province [129]
0
0
Hvidovre
Query!
Country [130]
0
0
Denmark
Query!
State/province [130]
0
0
Randers
Query!
Country [131]
0
0
Denmark
Query!
State/province [131]
0
0
Svendborg
Query!
Country [132]
0
0
Denmark
Query!
State/province [132]
0
0
Viborg
Query!
Country [133]
0
0
Finland
Query!
State/province [133]
0
0
Jyvaskyla
Query!
Country [134]
0
0
Finland
Query!
State/province [134]
0
0
Oulu
Query!
Country [135]
0
0
Finland
Query!
State/province [135]
0
0
Tampere
Query!
Country [136]
0
0
France
Query!
State/province [136]
0
0
Bayonne Cedex
Query!
Country [137]
0
0
France
Query!
State/province [137]
0
0
Herault
Query!
Country [138]
0
0
France
Query!
State/province [138]
0
0
Besancon Cedex
Query!
Country [139]
0
0
France
Query!
State/province [139]
0
0
Beziers Cedex
Query!
Country [140]
0
0
France
Query!
State/province [140]
0
0
Bordeaux Cedex
Query!
Country [141]
0
0
France
Query!
State/province [141]
0
0
Grenoble
Query!
Country [142]
0
0
France
Query!
State/province [142]
0
0
Lyon
Query!
Country [143]
0
0
France
Query!
State/province [143]
0
0
Paris cedex 10
Query!
Country [144]
0
0
France
Query!
State/province [144]
0
0
Poitiers
Query!
Country [145]
0
0
France
Query!
State/province [145]
0
0
Pontoise
Query!
Country [146]
0
0
France
Query!
State/province [146]
0
0
Rennes Cedex 9
Query!
Country [147]
0
0
France
Query!
State/province [147]
0
0
Toulouse Cedex
Query!
Country [148]
0
0
France
Query!
State/province [148]
0
0
Tourcoing
Query!
Country [149]
0
0
France
Query!
State/province [149]
0
0
Vandoeuvre Les Nancy
Query!
Country [150]
0
0
Germany
Query!
State/province [150]
0
0
Sachsen
Query!
Country [151]
0
0
Germany
Query!
State/province [151]
0
0
Aachen
Query!
Country [152]
0
0
Germany
Query!
State/province [152]
0
0
Bad Homburg
Query!
Country [153]
0
0
Germany
Query!
State/province [153]
0
0
Bad Krozingen
Query!
Country [154]
0
0
Germany
Query!
State/province [154]
0
0
Bamberg
Query!
Country [155]
0
0
Germany
Query!
State/province [155]
0
0
Berlin Buch
Query!
Country [156]
0
0
Germany
Query!
State/province [156]
0
0
Berlin
Query!
Country [157]
0
0
Germany
Query!
State/province [157]
0
0
Chemnitz
Query!
Country [158]
0
0
Germany
Query!
State/province [158]
0
0
Dessau-Roßlau
Query!
Country [159]
0
0
Germany
Query!
State/province [159]
0
0
Dresden
Query!
Country [160]
0
0
Germany
Query!
State/province [160]
0
0
Duisburg
Query!
Country [161]
0
0
Germany
Query!
State/province [161]
0
0
Eilenburg
Query!
Country [162]
0
0
Germany
Query!
State/province [162]
0
0
Elsterwerda
Query!
Country [163]
0
0
Germany
Query!
State/province [163]
0
0
Essen
Query!
Country [164]
0
0
Germany
Query!
State/province [164]
0
0
Frankfurt
Query!
Country [165]
0
0
Germany
Query!
State/province [165]
0
0
Hamburg
Query!
Country [166]
0
0
Germany
Query!
State/province [166]
0
0
Hassloch
Query!
Country [167]
0
0
Germany
Query!
State/province [167]
0
0
Heidenau
Query!
Country [168]
0
0
Germany
Query!
State/province [168]
0
0
Heppenheim
Query!
Country [169]
0
0
Germany
Query!
State/province [169]
0
0
Homburg
Query!
Country [170]
0
0
Germany
Query!
State/province [170]
0
0
Ingelheim
Query!
Country [171]
0
0
Germany
Query!
State/province [171]
0
0
Jena
Query!
Country [172]
0
0
Germany
Query!
State/province [172]
0
0
Kassel
Query!
Country [173]
0
0
Germany
Query!
State/province [173]
0
0
Kleve
Query!
Country [174]
0
0
Germany
Query!
State/province [174]
0
0
Koblenz
Query!
Country [175]
0
0
Germany
Query!
State/province [175]
0
0
Koeln
Query!
Country [176]
0
0
Germany
Query!
State/province [176]
0
0
Leipzig
Query!
Country [177]
0
0
Germany
Query!
State/province [177]
0
0
Loehne
Query!
Country [178]
0
0
Germany
Query!
State/province [178]
0
0
Ludwigshafen
Query!
Country [179]
0
0
Germany
Query!
State/province [179]
0
0
Lutherstadt Wittenberg
Query!
Country [180]
0
0
Germany
Query!
State/province [180]
0
0
Lüneburg
Query!
Country [181]
0
0
Germany
Query!
State/province [181]
0
0
Mainz
Query!
Country [182]
0
0
Germany
Query!
State/province [182]
0
0
Meißen
Query!
Country [183]
0
0
Germany
Query!
State/province [183]
0
0
Memmingen
Query!
Country [184]
0
0
Germany
Query!
State/province [184]
0
0
Muehldorf Am Inn
Query!
Country [185]
0
0
Germany
Query!
State/province [185]
0
0
Muehldorf
Query!
Country [186]
0
0
Germany
Query!
State/province [186]
0
0
Muenster
Query!
Country [187]
0
0
Germany
Query!
State/province [187]
0
0
Munchen
Query!
Country [188]
0
0
Germany
Query!
State/province [188]
0
0
Munich
Query!
Country [189]
0
0
Germany
Query!
State/province [189]
0
0
Nienburg
Query!
Country [190]
0
0
Germany
Query!
State/province [190]
0
0
Northeim
Query!
Country [191]
0
0
Germany
Query!
State/province [191]
0
0
Oschatz
Query!
Country [192]
0
0
Germany
Query!
State/province [192]
0
0
Papenburg
Query!
Country [193]
0
0
Germany
Query!
State/province [193]
0
0
Reinfeld
Query!
Country [194]
0
0
Germany
Query!
State/province [194]
0
0
Riesa
Query!
Country [195]
0
0
Germany
Query!
State/province [195]
0
0
Rodgau
Query!
Country [196]
0
0
Germany
Query!
State/province [196]
0
0
Siegen
Query!
Country [197]
0
0
Germany
Query!
State/province [197]
0
0
Ulm
Query!
Country [198]
0
0
Germany
Query!
State/province [198]
0
0
Wermsdorf
Query!
Country [199]
0
0
Germany
Query!
State/province [199]
0
0
Weyhe
Query!
Country [200]
0
0
Germany
Query!
State/province [200]
0
0
Witten
Query!
Country [201]
0
0
Germany
Query!
State/province [201]
0
0
Wuerzburg
Query!
Country [202]
0
0
Greece
Query!
State/province [202]
0
0
Attica
Query!
Country [203]
0
0
Greece
Query!
State/province [203]
0
0
GR
Query!
Country [204]
0
0
Greece
Query!
State/province [204]
0
0
Athens
Query!
Country [205]
0
0
Greece
Query!
State/province [205]
0
0
Thessaloniki
Query!
Country [206]
0
0
Guatemala
Query!
State/province [206]
0
0
Guatemala City
Query!
Country [207]
0
0
Hungary
Query!
State/province [207]
0
0
Zala
Query!
Country [208]
0
0
Hungary
Query!
State/province [208]
0
0
Budapest
Query!
Country [209]
0
0
Hungary
Query!
State/province [209]
0
0
Cegled
Query!
Country [210]
0
0
Hungary
Query!
State/province [210]
0
0
Kistarcsa
Query!
Country [211]
0
0
Hungary
Query!
State/province [211]
0
0
Mako
Query!
Country [212]
0
0
Hungary
Query!
State/province [212]
0
0
Nyiregyháza
Query!
Country [213]
0
0
Hungary
Query!
State/province [213]
0
0
Pecs
Query!
Country [214]
0
0
Hungary
Query!
State/province [214]
0
0
Pécs
Query!
Country [215]
0
0
Hungary
Query!
State/province [215]
0
0
Szeged
Query!
Country [216]
0
0
Hungary
Query!
State/province [216]
0
0
Szekesfehervar
Query!
Country [217]
0
0
India
Query!
State/province [217]
0
0
Andhra Pradesh
Query!
Country [218]
0
0
India
Query!
State/province [218]
0
0
Delhi
Query!
Country [219]
0
0
India
Query!
State/province [219]
0
0
Gujarat
Query!
Country [220]
0
0
India
Query!
State/province [220]
0
0
Haryana
Query!
Country [221]
0
0
India
Query!
State/province [221]
0
0
Kerala
Query!
Country [222]
0
0
India
Query!
State/province [222]
0
0
Maharashtra
Query!
Country [223]
0
0
India
Query!
State/province [223]
0
0
Punjab
Query!
Country [224]
0
0
India
Query!
State/province [224]
0
0
Rajasthan
Query!
Country [225]
0
0
India
Query!
State/province [225]
0
0
Tamil NADU
Query!
Country [226]
0
0
India
Query!
State/province [226]
0
0
Tamil Nadu
Query!
Country [227]
0
0
India
Query!
State/province [227]
0
0
West Bengal
Query!
Country [228]
0
0
India
Query!
State/province [228]
0
0
New Delhi
Query!
Country [229]
0
0
Israel
Query!
State/province [229]
0
0
Hadera
Query!
Country [230]
0
0
Israel
Query!
State/province [230]
0
0
Haifa
Query!
Country [231]
0
0
Israel
Query!
State/province [231]
0
0
Lower Galilee
Query!
Country [232]
0
0
Israel
Query!
State/province [232]
0
0
Nahariya
Query!
Country [233]
0
0
Israel
Query!
State/province [233]
0
0
Petach Tikva
Query!
Country [234]
0
0
Israel
Query!
State/province [234]
0
0
Ramat Gan
Query!
Country [235]
0
0
Israel
Query!
State/province [235]
0
0
Rehovot
Query!
Country [236]
0
0
Israel
Query!
State/province [236]
0
0
Tel Giborim, Holon
Query!
Country [237]
0
0
Italy
Query!
State/province [237]
0
0
AO
Query!
Country [238]
0
0
Italy
Query!
State/province [238]
0
0
AR
Query!
Country [239]
0
0
Italy
Query!
State/province [239]
0
0
BG
Query!
Country [240]
0
0
Italy
Query!
State/province [240]
0
0
BO
Query!
Country [241]
0
0
Italy
Query!
State/province [241]
0
0
BS
Query!
Country [242]
0
0
Italy
Query!
State/province [242]
0
0
FE
Query!
Country [243]
0
0
Italy
Query!
State/province [243]
0
0
IS
Query!
Country [244]
0
0
Italy
Query!
State/province [244]
0
0
MB
Query!
Country [245]
0
0
Italy
Query!
State/province [245]
0
0
ME
Query!
Country [246]
0
0
Italy
Query!
State/province [246]
0
0
MI
Query!
Country [247]
0
0
Italy
Query!
State/province [247]
0
0
PD
Query!
Country [248]
0
0
Italy
Query!
State/province [248]
0
0
PG
Query!
Country [249]
0
0
Italy
Query!
State/province [249]
0
0
PV
Query!
Country [250]
0
0
Italy
Query!
State/province [250]
0
0
RM
Query!
Country [251]
0
0
Italy
Query!
State/province [251]
0
0
SS
Query!
Country [252]
0
0
Italy
Query!
State/province [252]
0
0
TS
Query!
Country [253]
0
0
Italy
Query!
State/province [253]
0
0
UD
Query!
Country [254]
0
0
Italy
Query!
State/province [254]
0
0
Va
Query!
Country [255]
0
0
Italy
Query!
State/province [255]
0
0
VE
Query!
Country [256]
0
0
Italy
Query!
State/province [256]
0
0
Milano
Query!
Country [257]
0
0
Italy
Query!
State/province [257]
0
0
Napoli
Query!
Country [258]
0
0
Japan
Query!
State/province [258]
0
0
Aichi
Query!
Country [259]
0
0
Japan
Query!
State/province [259]
0
0
Fukuka
Query!
Country [260]
0
0
Japan
Query!
State/province [260]
0
0
Gifu
Query!
Country [261]
0
0
Japan
Query!
State/province [261]
0
0
Gunma
Query!
Country [262]
0
0
Japan
Query!
State/province [262]
0
0
Hyogo
Query!
Country [263]
0
0
Japan
Query!
State/province [263]
0
0
Ishikawa
Query!
Country [264]
0
0
Japan
Query!
State/province [264]
0
0
Iwate
Query!
Country [265]
0
0
Japan
Query!
State/province [265]
0
0
Kagawa
Query!
Country [266]
0
0
Japan
Query!
State/province [266]
0
0
Kanagawa
Query!
Country [267]
0
0
Japan
Query!
State/province [267]
0
0
Miyagi
Query!
Country [268]
0
0
Japan
Query!
State/province [268]
0
0
Nara
Query!
Country [269]
0
0
Japan
Query!
State/province [269]
0
0
Saitama
Query!
Country [270]
0
0
Japan
Query!
State/province [270]
0
0
Shiga
Query!
Country [271]
0
0
Japan
Query!
State/province [271]
0
0
Tokyo
Query!
Country [272]
0
0
Korea, Republic of
Query!
State/province [272]
0
0
Bucheon Si
Query!
Country [273]
0
0
Korea, Republic of
Query!
State/province [273]
0
0
Chungcheongbuk Do
Query!
Country [274]
0
0
Korea, Republic of
Query!
State/province [274]
0
0
Gangwon-do
Query!
Country [275]
0
0
Korea, Republic of
Query!
State/province [275]
0
0
Gyeonggi Do
Query!
Country [276]
0
0
Korea, Republic of
Query!
State/province [276]
0
0
Korea
Query!
Country [277]
0
0
Korea, Republic of
Query!
State/province [277]
0
0
KOR
Query!
Country [278]
0
0
Korea, Republic of
Query!
State/province [278]
0
0
Daegu
Query!
Country [279]
0
0
Korea, Republic of
Query!
State/province [279]
0
0
Seoul
Query!
Country [280]
0
0
Mexico
Query!
State/province [280]
0
0
Coahulia
Query!
Country [281]
0
0
Mexico
Query!
State/province [281]
0
0
Distrito Federal
Query!
Country [282]
0
0
Mexico
Query!
State/province [282]
0
0
Guanajuato
Query!
Country [283]
0
0
Mexico
Query!
State/province [283]
0
0
Jalisco
Query!
Country [284]
0
0
Mexico
Query!
State/province [284]
0
0
Queretaro
Query!
Country [285]
0
0
Mexico
Query!
State/province [285]
0
0
San Luis Potosí
Query!
Country [286]
0
0
Mexico
Query!
State/province [286]
0
0
Sinaloa
Query!
Country [287]
0
0
Mexico
Query!
State/province [287]
0
0
Aguascalientes
Query!
Country [288]
0
0
Mexico
Query!
State/province [288]
0
0
San Luis Potosi
Query!
Country [289]
0
0
Netherlands
Query!
State/province [289]
0
0
DZ
Query!
Country [290]
0
0
Netherlands
Query!
State/province [290]
0
0
NL
Query!
Country [291]
0
0
Netherlands
Query!
State/province [291]
0
0
PP
Query!
Country [292]
0
0
Netherlands
Query!
State/province [292]
0
0
Arnhem
Query!
Country [293]
0
0
Netherlands
Query!
State/province [293]
0
0
Blaricum
Query!
Country [294]
0
0
Netherlands
Query!
State/province [294]
0
0
Den Haag
Query!
Country [295]
0
0
Netherlands
Query!
State/province [295]
0
0
Ede
Query!
Country [296]
0
0
Netherlands
Query!
State/province [296]
0
0
Gouda
Query!
Country [297]
0
0
Netherlands
Query!
State/province [297]
0
0
Groningen
Query!
Country [298]
0
0
Netherlands
Query!
State/province [298]
0
0
Hardenberg
Query!
Country [299]
0
0
Netherlands
Query!
State/province [299]
0
0
Harderwijk
Query!
Country [300]
0
0
Netherlands
Query!
State/province [300]
0
0
Nijmegen
Query!
Country [301]
0
0
Netherlands
Query!
State/province [301]
0
0
Rotterdam
Query!
Country [302]
0
0
Netherlands
Query!
State/province [302]
0
0
Sneek
Query!
Country [303]
0
0
Netherlands
Query!
State/province [303]
0
0
Tilburg
Query!
Country [304]
0
0
Norway
Query!
State/province [304]
0
0
Loerenskog
Query!
Country [305]
0
0
Norway
Query!
State/province [305]
0
0
Oslo
Query!
Country [306]
0
0
Norway
Query!
State/province [306]
0
0
Stavanger
Query!
Country [307]
0
0
Norway
Query!
State/province [307]
0
0
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Perm
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St Petersburg
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St.- Petersburg
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TUR
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Turkey
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Sivas
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GBR
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Coventry
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Dundee
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Glasgow
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Hull
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London
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Newport
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Nottingham
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Sheffield
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Swindon
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Wiltshire
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United Kingdom
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Wrexham
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Novartis Pharmaceuticals
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study was to evaluate the effect of LCZ696 compared to valsartan in the reduction of cardiovascular death and heart failure(HF) hospitalizations in patients with HF with preserved ejection fraction.
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Trial website
https://clinicaltrials.gov/study/NCT01920711
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Trial related presentations / publications
Butt JH, Dewan P, Jhund PS, Anand IS, Atar D, Ge J, Desai AS, Echeverria LE, Kober L, Lam CSP, Maggioni AP, Martinez F, Packer M, Rouleau JL, Sim D, Van Veldhuisen DJ, Vrtovec B, Zannad F, Zile MR, Gong J, Lefkowitz MP, Rizkala AR, Solomon SD, McMurray JJV. Sacubitril/Valsartan and Frailty in Patients With Heart Failure and Preserved Ejection Fraction. J Am Coll Cardiol. 2022 Sep 20;80(12):1130-1143. doi: 10.1016/j.jacc.2022.06.037. Epub 2022 Aug 29. Wijkman MO, Claggett B, Vaduganathan M, Cunningham JW, Rorth R, Jackson A, Packer M, Zile M, Rouleau J, Swedberg K, Lefkowitz M, Shah SJ, Pfeffer MA, McMurray JJV, Solomon SD. Effects of sacubitril/valsartan on glycemia in patients with diabetes and heart failure: the PARAGON-HF and PARADIGM-HF trials. Cardiovasc Diabetol. 2022 Jun 18;21(1):110. doi: 10.1186/s12933-022-01545-1. Vaduganathan M, Claggett BL, Inciardi RM, Fonarow GC, McMurray JJV, Solomon SD. Estimating the Benefits of Combination Medical Therapy in Heart Failure With Mildly Reduced and Preserved Ejection Fraction. Circulation. 2022 Jun 7;145(23):1741-1743. doi: 10.1161/CIRCULATIONAHA.121.058929. Epub 2022 May 23. No abstract available. Vaduganathan M, Claggett BL, McMurray JJV, Solomon SD. Health Status Trajectories Before and After Hospitalization for Heart Failure. Circulation. 2022 Jun 21;145(25):1872-1874. doi: 10.1161/CIRCULATIONAHA.122.059282. Epub 2022 May 21. No abstract available. Cikes M, Planinc I, Claggett B, Cunningham J, Milicic D, Sweitzer N, Senni M, Gori M, Linssen G, Shah SJ, Packer M, Pfeffer M, Zile MR, Anand I, Chiang LM, Lam CSP, Redfield M, Desai AS, McMurray JJV, Solomon SD. Atrial Fibrillation in Heart Failure With Preserved Ejection Fraction: The PARAGON-HF Trial. JACC Heart Fail. 2022 May;10(5):336-346. doi: 10.1016/j.jchf.2022.01.018. Epub 2022 Apr 6. Jackson AM, Rorth R, Liu J, Kristensen SL, Anand IS, Claggett BL, Cleland JGF, Chopra VK, Desai AS, Ge J, Gong J, Lam CSP, Lefkowitz MP, Maggioni AP, Martinez F, Packer M, Pfeffer MA, Pieske B, Redfield MM, Rizkala AR, Rouleau JL, Seferovic PM, Tromp J, Van Veldhuisen DJ, Yilmaz MB, Zannad F, Zile MR, Kober L, Petrie MC, Jhund PS, Solomon SD, McMurray JJV; PARAGON-HF Committees and Investigators. Diabetes and pre-diabetes in patients with heart failure and preserved ejection fraction. Eur J Heart Fail. 2022 Mar;24(3):497-509. doi: 10.1002/ejhf.2403. Epub 2022 Jan 4. Desai AS, Vaduganathan M, Cleland JG, Claggett BL, Barkoudah E, Finn P, McCausland FR, Yilmaz MB, Lefkowitz M, Shi V, Pfeffer MA, McMurray JJV, Solomon SD. Mode of Death in Patients With Heart Failure and Preserved Ejection Fraction: Insights From PARAGON-HF Trial. Circ Heart Fail. 2021 Dec;14(12):e008597. doi: 10.1161/CIRCHEARTFAILURE.121.008597. Epub 2021 Nov 22. Mooney L, Hawkins NM, Jhund PS, Redfield MM, Vaduganathan M, Desai AS, Rouleau JL, Minamisawa M, Shah AM, Lefkowitz MP, Zile MR, Van Veldhuisen DJ, Pfeffer MA, Anand IS, Maggioni AP, Senni M, Claggett BL, Solomon SD, McMurray JJV. Impact of Chronic Obstructive Pulmonary Disease in Patients With Heart Failure With Preserved Ejection Fraction: Insights From PARAGON-HF. J Am Heart Assoc. 2021 Dec 7;10(23):e021494. doi: 10.1161/JAHA.121.021494. Epub 2021 Nov 19. Jackson AM, Jhund PS, Anand IS, Dungen HD, Lam CSP, Lefkowitz MP, Linssen G, Lund LH, Maggioni AP, Pfeffer MA, Rouleau JL, Saraiva JFK, Senni M, Vardeny O, Wijkman MO, Yilmaz MB, Saito Y, Zile MR, Solomon SD, McMurray JJV. Sacubitril-valsartan as a treatment for apparent resistant hypertension in patients with heart failure and preserved ejection fraction. Eur Heart J. 2021 Sep 21;42(36):3741-3752. doi: 10.1093/eurheartj/ehab499. Felker GM, Butler J, Januzzi JL Jr, Desai AS, McMurray JJV, Solomon SD. Probabilistic Readjudication of Heart Failure Hospitalization Events in the PARAGON-HF Study. Circulation. 2021 Jun 8;143(23):2316-2318. doi: 10.1161/CIRCULATIONAHA.121.054496. Epub 2021 Jun 7. No abstract available. Selvaraj S, Claggett BL, Packer M, Zannad F, Anand IS, Pieske B, Zhao Z, Shi VC, Lefkowitz MP, McMurray JJV, Solomon SD. Effects of Sacubitril/Valsartan on Serum Lipids in Heart Failure With Preserved Ejection Fraction. J Am Heart Assoc. 2021 Sep 7;10(17):e022069. doi: 10.1161/JAHA.121.022069. Epub 2021 May 16. Shen L, Jhund PS, Anand IS, Bhatt AS, Desai AS, Maggioni AP, Martinez FA, Pfeffer MA, Rizkala AR, Rouleau JL, Swedberg K, Vaduganathan M, Vardeny O, van Veldhuisen DJ, Zannad F, Zile MR, Packer M, Solomon SD, McMurray JJV. Incidence and Outcomes of Pneumonia in Patients With Heart Failure. J Am Coll Cardiol. 2021 Apr 27;77(16):1961-1973. doi: 10.1016/j.jacc.2021.03.001. Tromp J, Claggett BL, Liu J, Jackson AM, Jhund PS, Kober L, Widimsky J, Boytsov SA, Chopra VK, Anand IS, Ge J, Chen CH, Maggioni AP, Martinez F, Packer M, Pfeffer MA, Pieske B, Redfield MM, Rouleau JL, Van Veldhuisen DJ, Zannad F, Zile MR, Rizkala AR, Inubushi-Molessa A, Lefkowitz MP, Shi VC, McMurray JJV, Solomon SD, Lam CSP; PARAGON-HF Investigators. Global Differences in Heart Failure With Preserved Ejection Fraction: The PARAGON-HF Trial. Circ Heart Fail. 2021 Apr;14(4):e007901. doi: 10.1161/CIRCHEARTFAILURE.120.007901. Epub 2021 Apr 19. Vaduganathan M, Cunningham JW, Claggett BL, Causland FM, Barkoudah E, Finn P, Zannad F, Pfeffer MA, Rizkala AR, Sabarwal S, McMurray JJV, Solomon S, Desai AS. Worsening Heart Failure Episodes Outside a Hospital Setting in Heart Failure With Preserved Ejection Fraction: The PARAGON-HF Trial. JACC Heart Fail. 2021 May;9(5):374-382. doi: 10.1016/j.jchf.2021.01.014. Epub 2021 Apr 7. Gronda E, Vanoli E, Iacoviello M. The PARAGON-HF trial: the sacubitril/valsartan in heart failure with preserved ejection fraction. Eur Heart J Suppl. 2020 Nov 18;22(Suppl L):L77-L81. doi: 10.1093/eurheartj/suaa140. eCollection 2020 Nov. Jering K, Claggett B, Redfield MM, Shah SJ, Anand IS, Martinez F, Sabarwal SV, Seferovic PM, Kerr Saraiva JF, Katova T, Lefkowitz MP, Pfeffer MA, McMurray JJV, Solomon SD. Burden of Heart Failure Signs and Symptoms, Prognosis, and Response to Therapy: The PARAGON-HF Trial. JACC Heart Fail. 2021 May;9(5):386-397. doi: 10.1016/j.jchf.2021.01.011. Epub 2021 Mar 10. Jering KS, Zannad F, Claggett B, Mc Causland FR, Ferreira JP, Desai A, Barkoudah E, McMurray JJV, Pfeffer MA, Solomon SD. Cardiovascular and Renal Outcomes of Mineralocorticoid Receptor Antagonist Use in PARAGON-HF. JACC Heart Fail. 2021 Jan;9(1):13-24. doi: 10.1016/j.jchf.2020.08.014. Epub 2020 Nov 11. Mc Causland FR, Lefkowitz MP, Claggett B, Anavekar NS, Senni M, Gori M, Jhund PS, McGrath MM, Packer M, Shi V, Van Veldhuisen DJ, Zannad F, Comin-Colet J, Pfeffer MA, McMurray JJV, Solomon SD. Angiotensin-Neprilysin Inhibition and Renal Outcomes in Heart Failure With Preserved Ejection Fraction. Circulation. 2020 Sep 29;142(13):1236-1245. doi: 10.1161/CIRCULATIONAHA.120.047643. Epub 2020 Aug 17. Cunningham JW, Claggett BL, O'Meara E, Prescott MF, Pfeffer MA, Shah SJ, Redfield MM, Zannad F, Chiang LM, Rizkala AR, Shi VC, Lefkowitz MP, Rouleau J, McMurray JJV, Solomon SD, Zile MR. Effect of Sacubitril/Valsartan on Biomarkers of Extracellular Matrix Regulation in Patients With HFpEF. J Am Coll Cardiol. 2020 Aug 4;76(5):503-514. doi: 10.1016/j.jacc.2020.05.072. Cunningham JW, Vaduganathan M, Claggett BL, Zile MR, Anand IS, Packer M, Zannad F, Lam CSP, Janssens S, Jhund PS, Kober L, Rouleau J, Shah SJ, Chopra VK, Shi VC, Lefkowitz MP, Prescott MF, Pfeffer MA, McMurray JJV, Solomon SD. Effects of Sacubitril/Valsartan on N-Terminal Pro-B-Type Natriuretic Peptide in Heart Failure With Preserved Ejection Fraction. JACC Heart Fail. 2020 May;8(5):372-381. doi: 10.1016/j.jchf.2020.03.002. Epub 2020 Mar 30. Selvaraj S, Claggett BL, Bohm M, Anker SD, Vaduganathan M, Zannad F, Pieske B, Lam CSP, Anand IS, Shi VC, Lefkowitz MP, McMurray JJV, Solomon SD. Systolic Blood Pressure in Heart Failure With Preserved Ejection Fraction Treated With Sacubitril/Valsartan. J Am Coll Cardiol. 2020 Apr 14;75(14):1644-1656. doi: 10.1016/j.jacc.2020.02.009. Epub 2020 Mar 16. Shah AM, Cikes M, Prasad N, Li G, Getchevski S, Claggett B, Rizkala A, Lukashevich I, O'Meara E, Ryan JJ, Shah SJ, Mullens W, Zile MR, Lam CSP, McMurray JJV, Solomon SD; PARAGON-HF Investigators. Echocardiographic Features of Patients With Heart Failure and Preserved Left Ventricular Ejection Fraction. J Am Coll Cardiol. 2019 Dec 10;74(23):2858-2873. doi: 10.1016/j.jacc.2019.09.063. Solomon SD, Vaduganathan M, L Claggett B, Packer M, Zile M, Swedberg K, Rouleau J, A Pfeffer M, Desai A, Lund LH, Kober L, Anand I, Sweitzer N, Linssen G, Merkely B, Luis Arango J, Vinereanu D, Chen CH, Senni M, Sibulo A, Boytsov S, Shi V, Rizkala A, Lefkowitz M, McMurray JJV. Sacubitril/Valsartan Across the Spectrum of Ejection Fraction in Heart Failure. Circulation. 2020 Feb 4;141(5):352-361. doi: 10.1161/CIRCULATIONAHA.119.044586. Epub 2019 Nov 17. McMurray JJV, Jackson AM, Lam CSP, Redfield MM, Anand IS, Ge J, Lefkowitz MP, Maggioni AP, Martinez F, Packer M, Pfeffer MA, Pieske B, Rizkala AR, Sabarwal SV, Shah AM, Shah SJ, Shi VC, van Veldhuisen DJ, Zannad F, Zile MR, Cikes M, Goncalvesova E, Katova T, Kosztin A, Lelonek M, Sweitzer N, Vardeny O, Claggett B, Jhund PS, Solomon SD. Effects of Sacubitril-Valsartan Versus Valsartan in Women Compared With Men With Heart Failure and Preserved Ejection Fraction: Insights From PARAGON-HF. Circulation. 2020 Feb 4;141(5):338-351. doi: 10.1161/CIRCULATIONAHA.119.044491. Epub 2019 Nov 17. Vaduganathan M, Claggett BL, Desai AS, Anker SD, Perrone SV, Janssens S, Milicic D, Arango JL, Packer M, Shi VC, Lefkowitz MP, McMurray JJV, Solomon SD. Prior Heart Failure Hospitalization, Clinical Outcomes, and Response to Sacubitril/Valsartan Compared With Valsartan in HFpEF. J Am Coll Cardiol. 2020 Jan 28;75(3):245-254. doi: 10.1016/j.jacc.2019.11.003. Epub 2019 Nov 11. Solomon SD, McMurray JJV, Anand IS, Ge J, Lam CSP, Maggioni AP, Martinez F, Packer M, Pfeffer MA, Pieske B, Redfield MM, Rouleau JL, van Veldhuisen DJ, Zannad F, Zile MR, Desai AS, Claggett B, Jhund PS, Boytsov SA, Comin-Colet J, Cleland J, Dungen HD, Goncalvesova E, Katova T, Kerr Saraiva JF, Lelonek M, Merkely B, Senni M, Shah SJ, Zhou J, Rizkala AR, Gong J, Shi VC, Lefkowitz MP; PARAGON-HF Investigators and Committees. Angiotensin-Neprilysin Inhibition in Heart Failure with Preserved Ejection Fraction. N Engl J Med. 2019 Oct 24;381(17):1609-1620. doi: 10.1056/NEJMoa1908655. Epub 2019 Sep 1. Chandra A, Vaduganathan M, Lewis EF, Claggett BL, Rizkala AR, Wang W, Lefkowitz MP, Shi VC, Anand IS, Ge J, Lam CSP, Maggioni AP, Martinez F, Packer M, Pfeffer MA, Pieske B, Redfield MM, Rouleau JL, Van Veldhuisen DJ, Zannad F, Zile MR, McMurray JJV, Solomon SD; PARAGON-HF Investigators. Health-Related Quality of Life in Heart Failure With Preserved Ejection Fraction: The PARAGON-HF Trial. JACC Heart Fail. 2019 Oct;7(10):862-874. doi: 10.1016/j.jchf.2019.05.015. Epub 2019 Jul 10. Solomon SD, Rizkala AR, Lefkowitz MP, Shi VC, Gong J, Anavekar N, Anker SD, Arango JL, Arenas JL, Atar D, Ben-Gal T, Boytsov SA, Chen CH, Chopra VK, Cleland J, Comin-Colet J, Duengen HD, Echeverria Correa LE, Filippatos G, Flammer AJ, Galinier M, Godoy A, Goncalvesova E, Janssens S, Katova T, Kober L, Lelonek M, Linssen G, Lund LH, O'Meara E, Merkely B, Milicic D, Oh BH, Perrone SV, Ranjith N, Saito Y, Saraiva JF, Shah S, Seferovic PM, Senni M, Sibulo AS Jr, Sim D, Sweitzer NK, Taurio J, Vinereanu D, Vrtovec B, Widimsky J Jr, Yilmaz MB, Zhou J, Zweiker R, Anand IS, Ge J, Lam CSP, Maggioni AP, Martinez F, Packer M, Pfeffer MA, Pieske B, Redfield MM, Rouleau JL, Van Veldhuisen DJ, Zannad F, Zile MR, McMurray JJV. Baseline Characteristics of Patients With Heart Failure and Preserved Ejection Fraction in the PARAGON-HF Trial. Circ Heart Fail. 2018 Jul;11(7):e004962. doi: 10.1161/CIRCHEARTFAILURE.118.004962. Mutze T, Glimm E, Schmidli H, Friede T. Group sequential designs with robust semiparametric recurrent event models. Stat Methods Med Res. 2019 Aug;28(8):2385-2403. doi: 10.1177/0962280218780538. Epub 2018 Jun 11. Solomon SD, Rizkala AR, Gong J, Wang W, Anand IS, Ge J, Lam CSP, Maggioni AP, Martinez F, Packer M, Pfeffer MA, Pieske B, Redfield MM, Rouleau JL, Van Veldhuisen DJ, Zannad F, Zile MR, Desai AS, Shi VC, Lefkowitz MP, McMurray JJV. Angiotensin Receptor Neprilysin Inhibition in Heart Failure With Preserved Ejection Fraction: Rationale and Design of the PARAGON-HF Trial. JACC Heart Fail. 2017 Jul;5(7):471-482. doi: 10.1016/j.jchf.2017.04.013. Epub 2017 Jun 26. Rossi A, Gheorghiade M, Triposkiadis F, Solomon SD, Pieske B, Butler J. Left atrium in heart failure with preserved ejection fraction: structure, function, and significance. Circ Heart Fail. 2014 Nov;7(6):1042-9. doi: 10.1161/CIRCHEARTFAILURE.114.001276. No abstract available.
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Will individual participant data (IPD) for this trial be available (including data dictionaries)?
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Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.
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Study protocol
https://cdn.clinicaltrials.gov/large-docs/11/NCT01920711/Prot_000.pdf
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https://cdn.clinicaltrials.gov/large-docs/11/NCT01920711/SAP_001.pdf
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https://clinicaltrials.gov/study/NCT01920711