Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01164592




Registration number
NCT01164592
Ethics application status
Date submitted
15/07/2010
Date registered
16/07/2010
Date last updated
7/08/2015

Titles & IDs
Public title
Substudy on the Mechanistic Plausibility of the Clinical Benefits of Adaptive Servo-ventilation
Scientific title
SERVE-HF: Substudy on the Mechanistic Plausibility of the Clinical Benefits of Adaptive Servo-ventilation
Secondary ID [1] 0 0
01a
Universal Trial Number (UTN)
Trial acronym
MS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 0 0
Sleep Disorder 0 0
Cheyne Stokes Respiration 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Sleep apnoea
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Neurological 0 0 0 0
Other neurological disorders
Mental Health 0 0 0 0
Other mental health disorders
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - adaptive servoventilation (ASV)

Active comparator: Therapy with adaptive servo ventilation - optimal medical therapy + adaptive servoventilation

No intervention: Optimal medical therapy according to guidelines - optimal medical therapy


Treatment: Devices: adaptive servoventilation (ASV)
Patients randomised to therapygroup should use the adaptive servoventilation (ASV) device each night at least 3 hours
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in Left Ventricular Ejection Fraction (LVEF) from baseline to 12 months of therapy as measured by echocardiography (Echo).
Timepoint [1] 0 0
Baseline (Randomization), 6- and 12 month-Follow-up-visit
Secondary outcome [1] 0 0
Changes in left and right ventricular function
Timepoint [1] 0 0
Baseline (Randomization), 6-and 12-month-Follow-up visit
Secondary outcome [2] 0 0
Changes in LV systolic and diastolic indexed volumes
Timepoint [2] 0 0
Baseline (Randomization), 6- and 12-month-Follow-up-visit
Secondary outcome [3] 0 0
Changes in right ventricular (RV) systolic and diastolic indexed volumes
Timepoint [3] 0 0
Baseline (Randomization), 6- and 12-month-Follow-up-visit
Secondary outcome [4] 0 0
Changes in LV and RV mass
Timepoint [4] 0 0
Baseline (Randomization), 6- and 12-month-Follow-up-visit
Secondary outcome [5] 0 0
Changes in LV sphericity index and LV end-systolic global wall stress
Timepoint [5] 0 0
Baseline (Randomization), 6- and 12-month-Follow-up-visit
Secondary outcome [6] 0 0
Changes in sleep duration and sleep stages as well as arousals
Timepoint [6] 0 0
Baseline (Randomization), 6- and 12-month-Follow-up-visit
Secondary outcome [7] 0 0
Changes in sleep-disordered breathing
Timepoint [7] 0 0
Baseline (Randomization), 6- and 12-month-Follow-up-visit
Secondary outcome [8] 0 0
Changes in quality of life assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ)
Timepoint [8] 0 0
Baseline (Randomization), 6- and 12-month-Follow-up-visit
Secondary outcome [9] 0 0
Changes in mental status assessed by Mini-Mental State Examination (MMSE)
Timepoint [9] 0 0
Baseline (Randomization), 6- and 12-month-Follow-up-visit
Secondary outcome [10] 0 0
Changes in Patient Health Questionnaire-9 (PHQ-9) score and Patient Anxiety Questionnaire GAD-7
Timepoint [10] 0 0
Baseline (Randomization), 6- and 12-month-Follow-up-visit

Eligibility
Key inclusion criteria
The inclusion and exclusion criteria are mainly those applicable for the parent study; SERVE-HF. The inclusion and exclusion criteria are listed here.

INCLUSION CRITERIA FOR SERVE-HF STUDY:

* Over 22 years of age
* Severe Chronic Heart Failure (CHF) with NYHA class III-IV or NYHA class II with at least one hospitalisation for HF within the last 24 months
* Left ventricular ejection fraction (LVEF) less than or equal to 45% by means of echocardiography, radionucleotide angiography, left ventriculography or cardiac MRI documented less than 12 weeks before randomisation
* Diagnosis of sleep disordered breathing (SDB) with an apnoea-hypopnoea-index (AHI) of >15/hr with at least 50% central events and a central AHI of at least 10/hr
* Clinically stable with no change in medication and no unplanned hospitalisation for heart failure in preceding month
* Optimised medical treatment according to the applicable guidelines
* Able to provide informed consent

ADDITIONAL INCLUSION CRITERIA FOR THE SUBSTUDY

• Predominant central sleep apnoea (apnoea hypopnoea index > 15/hour with = 50% central events and a central AHI =10/hour, derived from full polysomnography (based on total sleep time), documented less than 4 weeks before randomization. Flow measurements have to be performed with nasal cannula

EXCLUSION CRITERIA FOR THE SERVE-HF STUDY:

* Significant chronic obstructive pulmonary disease (COPD) with Forced Expiratory Volume within one second (FEV1)<50% predicted
* Oxygen saturation at rest during the day 90% at the time of inclusion
* Current use of Positive Airway Pressure (PAP) therapy
* Life expectancy < 1 year for diseases unrelated to chronic heart failure
* Cardiac surgery, Percutaneous coronary intervention (PCI), Myocardial Infarction (MI) or unstable angina within 6 months prior to randomisation
* Implantation of ICD (implanted cardiodefibrillator) or CRT (cardiac resynchronisation therapy) scheduled or within 6 months prior to randomisation
* Transient ischemic attack (TIA) or Stroke within 3 months prior to randomisation
* Primary hemodynamically significant uncorrected valvular heart disease, obstructive or regurgitant, or any valvular disease expected to lead to surgery during the trial
* Acute myocarditis/pericarditis within 6 months prior to randomisation
* Untreated or therapy refractory Restless legs Syndrome (RLS)
* Pregnancy

ADDITIONAL EXCLUSION CRITERIA FOR THE SUBSTUDY

* Amyloidosis, hypertrophic obstructive cardiomyopathy or arteriovenous fistulas
* Dosage changes of diuretics more than doubled within the last 4 weeks prior to randomisation
Minimum age
22 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2015
Sample size
Target
Accrual to date
Final
312
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Westmead Hospital - Westmead
Recruitment hospital [2] 0 0
Rivercity Private Hospital - Auchenflower
Recruitment hospital [3] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [4] 0 0
Melbourne Sleep Disorders Centre - East Melbourne
Recruitment hospital [5] 0 0
St. Vincents and Mercy Private Hospital - Melbourne
Recruitment hospital [6] 0 0
Hollywood Private Hospital (CVS) - Nedlands
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
4066 - Auchenflower
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment postcode(s) [4] 0 0
3002 - East Melbourne
Recruitment postcode(s) [5] 0 0
3065 - Melbourne
Recruitment postcode(s) [6] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
Czech Republic
State/province [1] 0 0
Brno
Country [2] 0 0
Finland
State/province [2] 0 0
Helsinki
Country [3] 0 0
Finland
State/province [3] 0 0
Tampere
Country [4] 0 0
France
State/province [4] 0 0
Grenoble
Country [5] 0 0
France
State/province [5] 0 0
Poitiers
Country [6] 0 0
Germany
State/province [6] 0 0
Aachen
Country [7] 0 0
Germany
State/province [7] 0 0
Alzey
Country [8] 0 0
Germany
State/province [8] 0 0
Bad Krozingen
Country [9] 0 0
Germany
State/province [9] 0 0
Bad Oeynhausen
Country [10] 0 0
Germany
State/province [10] 0 0
Berlin
Country [11] 0 0
Germany
State/province [11] 0 0
Bielefeld
Country [12] 0 0
Germany
State/province [12] 0 0
Bonn
Country [13] 0 0
Germany
State/province [13] 0 0
Borna
Country [14] 0 0
Germany
State/province [14] 0 0
Brühl
Country [15] 0 0
Germany
State/province [15] 0 0
Castrop-Rauxel
Country [16] 0 0
Germany
State/province [16] 0 0
Dortmund
Country [17] 0 0
Germany
State/province [17] 0 0
Dresden
Country [18] 0 0
Germany
State/province [18] 0 0
Duesseldorf
Country [19] 0 0
Germany
State/province [19] 0 0
Düsseldorf
Country [20] 0 0
Germany
State/province [20] 0 0
Essen
Country [21] 0 0
Germany
State/province [21] 0 0
Flonheim
Country [22] 0 0
Germany
State/province [22] 0 0
Frankfurt
Country [23] 0 0
Germany
State/province [23] 0 0
Frechen
Country [24] 0 0
Germany
State/province [24] 0 0
Freiburg im Breisgau
Country [25] 0 0
Germany
State/province [25] 0 0
Gütersloh
Country [26] 0 0
Germany
State/province [26] 0 0
Hagen
Country [27] 0 0
Germany
State/province [27] 0 0
Hamburg
Country [28] 0 0
Germany
State/province [28] 0 0
Heidelberg
Country [29] 0 0
Germany
State/province [29] 0 0
Hemer
Country [30] 0 0
Germany
State/province [30] 0 0
Herne
Country [31] 0 0
Germany
State/province [31] 0 0
Herten
Country [32] 0 0
Germany
State/province [32] 0 0
Immenhausen
Country [33] 0 0
Germany
State/province [33] 0 0
Ingelheim
Country [34] 0 0
Germany
State/province [34] 0 0
Karlstadt
Country [35] 0 0
Germany
State/province [35] 0 0
Köln
Country [36] 0 0
Germany
State/province [36] 0 0
Leipzig
Country [37] 0 0
Germany
State/province [37] 0 0
Lübeck
Country [38] 0 0
Germany
State/province [38] 0 0
Menden
Country [39] 0 0
Germany
State/province [39] 0 0
Moers
Country [40] 0 0
Germany
State/province [40] 0 0
Mühldorf
Country [41] 0 0
Germany
State/province [41] 0 0
Mülheim an der Ruhr
Country [42] 0 0
Germany
State/province [42] 0 0
München
Country [43] 0 0
Germany
State/province [43] 0 0
Münster
Country [44] 0 0
Germany
State/province [44] 0 0
Neuss
Country [45] 0 0
Germany
State/province [45] 0 0
Nienburg
Country [46] 0 0
Germany
State/province [46] 0 0
Ratingen
Country [47] 0 0
Germany
State/province [47] 0 0
Regensburg
Country [48] 0 0
Germany
State/province [48] 0 0
Reinbek
Country [49] 0 0
Germany
State/province [49] 0 0
Unna
Country [50] 0 0
Germany
State/province [50] 0 0
Waldkraiburg
Country [51] 0 0
Germany
State/province [51] 0 0
Wiesbaden
Country [52] 0 0
Germany
State/province [52] 0 0
Wuerzburg
Country [53] 0 0
Germany
State/province [53] 0 0
Würzburg
Country [54] 0 0
Netherlands
State/province [54] 0 0
Groningen
Country [55] 0 0
Switzerland
State/province [55] 0 0
Lugano
Country [56] 0 0
United Kingdom
State/province [56] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
ResMed
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Martin Cowie, Prof
Address 0 0
Royal Brompton Hospital, London
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01164592