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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03579641




Registration number
NCT03579641
Ethics application status
Date submitted
4/06/2018
Date registered
6/07/2018
Date last updated
25/10/2022

Titles & IDs
Public title
Precision Event Monitoring for Patients With Heart Failure Using HeartLogic
Scientific title
Precision Event Monitoring for Patients With Heart Failure Using HeartLogic: PREEMPT-HF
Secondary ID [1] 0 0
PREEMPT-HF
Universal Trial Number (UTN)
Trial acronym
PREEMPT-HF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 0 0
Defibrillators, Implantable 0 0
Monitoring, Physiologic 0 0
Cardiac Resynchronization Therapy 0 0
Cardiovascular Disease 0 0
Heart Disease 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - HeartLogic Sensors

Implantable Cardiac device with HeartLogic feature - Patients with Heart Failure, implanted with Boston Scientific Implantable Cardioverter Defibrillator or Defibrillator with Cardiac Resynchronization device with HeartLogic feature


Treatment: Devices: HeartLogic Sensors
HeartLogic Sensors
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Association of HeartLogic sensors with 30-day HF re-admission
Timepoint [1] 0 0
Heartlogic sensor data will be evaluated for the association to HF re-admission during the 30 days after the index event (e.g. the first HF hospitalization that occurs during the trial).

Eligibility
Key inclusion criteria
- Subject is age 18 or above, or of legal age to give informed consent specific to each
country and national laws.

- Subject has a documented diagnosis of heart failure.

- Subject has a Boston Scientific Cardiac Resynchronization Therapy Defibrillator or
Implantable Cardioverter Defibrillator device implant that has HeartLogic, with Heart
Failure Sensors turned ON, Respiratory Sensor turned ON, and Sleep Incline Sensor
turned ON.

- Subject has an active bipolar right ventricle lead implant.

- Subject is enrolled in LATITUDE (NXT 5.0 or future version), and is willing to be
remotely monitored from the baseline visit for approximately 12 months with HeartLogic
disabled.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Subject has received or is scheduled to receive a heart transplant or ventricular
assist device (VAD).

- Subject is enrolled in any concurrent clinical study without prior Boston Scientific
written approval (excluding registries).

- Subject has a life expectancy of less than 12 months.

- Subject has a history of non-compliance to medical care or known inability to comply
with requirements of the clinical study protocol

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
29/10/2021
Sample size
Target
Accrual to date
Final
2184
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Prince Charles Hospital - Chermside
Recruitment postcode(s) [1] 0 0
- Chermside
Recruitment outside Australia
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United States of America
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Alabama
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Arkansas
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United States of America
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California
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Delaware
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Florida
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United States of America
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Illinois
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Iowa
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Kansas
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Maine
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Maryland
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Massachusetts
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Michigan
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Minnesota
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Mississippi
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Missouri
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New York
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North Carolina
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Ohio
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Oregon
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Pennsylvania
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South Carolina
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United States of America
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Tennessee
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Texas
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Virginia
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Washington
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United States of America
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West Virginia
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Belgium
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Aalst
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Canada
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Montréal
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Canada
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Ste-Foy
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Denmark
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Aarhus
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France
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Caen
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France
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Nantes
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France
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Paris
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France
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Saint-Priest-en-Jarez
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Germany
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Bochum
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Germany
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Lübeck
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Hong Kong
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Aberdeen
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Hong Kong
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Hong Kong
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Ireland
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Waterford
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Italy
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Catanzaro
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Italy
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Naples
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Italy
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Negrar
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Italy
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Verona
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Netherlands
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Amsterdam
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Netherlands
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Leiden
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Netherlands
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Utrecht
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Spain
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Barcelona
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Spain
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Las Palmas
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Spain
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Málaga
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United Kingdom
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Belfast
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United Kingdom
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Clydebank
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United Kingdom
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Dundee
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United Kingdom
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Edinburgh
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United Kingdom
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Manchester
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United Kingdom
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Sheffield
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United Kingdom
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Wolverhampton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Boston Scientific Corporation
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The goal of the PREEMPT-HF study is to collect device and clinical event data to evaluate
extended applications of the HeartLogic Heart Failure Diagnostic (HeartLogic) in a broad
spectrum of heart failure patients with an implantable cardioverter defibrillator or cardiac
resynchronization therapy defibrillator. There are no primary safety and/or efficacy
endpoints for this study.

Heart failure is a complex clinical syndrome with high morbidity, mortality, and economic
burden. Chronic Heart Failure is persistent, gradually progressive, and punctuated by
episodes of acute worsening leading to hospitalizations. Therefore, there remains an unmet
clinical need to slow the progression of Heart Failure and prevent hospitalizations.
HeartLogic, available in Boston Scientific cardiac resynchronization therapy devices and
defibrillators, combines novel sensor parameters such as heart sounds and respiration with
other measurements like thoracic impedance, heart rate, and activity into a HeartLogic Index
for the early detection of worsening Heart Failure. However, there is limited data on the
association of HeartLogic with the risk of Hear Failure readmissions and tachyarrhythmias, or
for phenotyping the broad spectrum of Heart Failure patients.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03579641
Trial related presentations / publications
Benjamin EJ, Blaha MJ, Chiuve SE, Cushman M, Das SR, Deo R, de Ferranti SD, Floyd J, Fornage M, Gillespie C, Isasi CR, Jimenez MC, Jordan LC, Judd SE, Lackland D, Lichtman JH, Lisabeth L, Liu S, Longenecker CT, Mackey RH, Matsushita K, Mozaffarian D, Mussolino ME, Nasir K, Neumar RW, Palaniappan L, Pandey DK, Thiagarajan RR, Reeves MJ, Ritchey M, Rodriguez CJ, Roth GA, Rosamond WD, Sasson C, Towfighi A, Tsao CW, Turner MB, Virani SS, Voeks JH, Willey JZ, Wilkins JT, Wu JH, Alger HM, Wong SS, Muntner P; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2017 Update: A Report From the American Heart Association. Circulation. 2017 Mar 7;135(10):e146-e603. doi: 10.1161/CIR.0000000000000485. Epub 2017 Jan 25. No abstract available. Erratum In: Circulation. 2017 Mar 7;135(10 ):e646. Circulation. 2017 Sep 5;136(10 ):e196.
Ambrosy AP, Fonarow GC, Butler J, Chioncel O, Greene SJ, Vaduganathan M, Nodari S, Lam CSP, Sato N, Shah AN, Gheorghiade M. The global health and economic burden of hospitalizations for heart failure: lessons learned from hospitalized heart failure registries. J Am Coll Cardiol. 2014 Apr 1;63(12):1123-1133. doi: 10.1016/j.jacc.2013.11.053. Epub 2014 Feb 5.
Gheorghiade M, Pang PS. Acute heart failure syndromes. J Am Coll Cardiol. 2009 Feb 17;53(7):557-573. doi: 10.1016/j.jacc.2008.10.041.
Boehmer JP, Hariharan R, Devecchi FG, Smith AL, Molon G, Capucci A, An Q, Averina V, Stolen CM, Thakur PH, Thompson JA, Wariar R, Zhang Y, Singh JP. A Multisensor Algorithm Predicts Heart Failure Events in Patients With Implanted Devices: Results From the MultiSENSE Study. JACC Heart Fail. 2017 Mar;5(3):216-225. doi: 10.1016/j.jchf.2016.12.011.
Whellan DJ, Lindenfeld J. Easy to Predict, Difficult to Prevent. JACC Heart Fail. 2017 Mar;5(3):226-228. doi: 10.1016/j.jchf.2017.01.006. No abstract available.
Desai AS. The three-phase terrain of heart failure readmissions. Circ Heart Fail. 2012 Jul 1;5(4):398-400. doi: 10.1161/CIRCHEARTFAILURE.112.968735. No abstract available.
Dharmarajan K, Wang Y, Lin Z, Normand ST, Ross JS, Horwitz LI, Desai NR, Suter LG, Drye EE, Bernheim SM, Krumholz HM. Association of Changing Hospital Readmission Rates With Mortality Rates After Hospital Discharge. JAMA. 2017 Jul 18;318(3):270-278. doi: 10.1001/jama.2017.8444.
Shah SJ, Katz DH, Selvaraj S, Burke MA, Yancy CW, Gheorghiade M, Bonow RO, Huang CC, Deo RC. Phenomapping for novel classification of heart failure with preserved ejection fraction. Circulation. 2015 Jan 20;131(3):269-79. doi: 10.1161/CIRCULATIONAHA.114.010637. Epub 2014 Nov 14.
Public notes

Contacts
Principal investigator
Name 0 0
Stephen Gaertner
Address 0 0
Boston Scientific Corporation
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03579641