Precision Event Monitoring for Patients With Heart Failure Using HeartLogic

Heart Failure Clinical Trial

— PREEMPT-HF  

Official title:

Precision Event Monitoring for Patients With Heart Failure Using HeartLogic: PREEMPT-HF

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03579641
• Other study ID #: PREEMPT-HF
• Status: Completed
• Start date: June 1, 2018
• Est. completion date: October 29, 2021

Study information

• Verified date: October 2022
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Subjects will be followed for approximately 12 months after the baseline visit to collect the required number of clinical events to support the study objectives. These events are called Reviewable Clinical Events, and include all-cause hospitalizations and Heart Failure outpatient visits.

Clinical event definitions are as follows:

• Hospitalization (all-cause): the subject is admitted to inpatient hospital care and discharged on a different calendar date.

• Heart Failure Hospitalization: the subject is admitted with signs/symptoms of congestive heart failure and receives unscheduled augmented Heart Failure therapy with oral or intravenous medications, ultrafiltration therapy or other parenteral therapy.

• Heart Failure Readmission (30-day): the subject is admitted for an unplanned hospitalization for any cause within 30 days post discharge from a Heart Failure hospitalization.

• Heart Failure Outpatient Visit: the subject has signs/symptoms of Congestive Heart Failure, and receives unscheduled intravenous decongestive therapy (e.g., Intravenous diuretics, Intravenous inotropes, Intravenous vasoactive drugs, ultrafiltration) in a setting that does not involve a hospitalization (e.g., emergency room, Heart Failure clinic, primary care clinic, etc.).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2184
• Est. completion date: October 29, 2021
• Est. primary completion date: October 29, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

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

Related Conditions & MeSH terms

• Cardiac Resynchronization Therapy
• Cardiovascular Disease
• Cardiovascular Diseases
• Defibrillators, Implantable
• Heart Disease
• Heart Diseases
• Heart Failure
• Monitoring, Physiologic

Intervention

Device:
• HeartLogic Sensors
HeartLogic Sensors

Locations

Country	Name	City	State
Australia	Prince Charles Hospital	Chermside
Belgium	OLVZ Aalst	Aalst
Canada	CHUM	Montréal
Canada	IUCPQ	Ste-Foy
Denmark	Aarhus University Hospital	Aarhus
France	CHU de Caen	Caen
France	CHU de Nantes - Hôpital Laennec	Nantes
France	APHP - Hospital de la Pitie-Salpetriere	Paris
France	CHU de St. Etienne	Saint-Priest-en-Jarez
Germany	Augusta Kranken Anstalt GmbH - Klinik für Kardiologie und Angiologie	Bochum
Germany	Universitaetsklinikum Schleswig-Holstein	Lübeck
Hong Kong	Grantham Hospital	Aberdeen
Hong Kong	Prince of Wales Hospital	Hong Kong
Hong Kong	Queen Mary Hospital	Hong Kong
Ireland	University Hospital Waterford	Waterford
Italy	Az. Osp. G. Ciaccio Pontepiccolo	Catanzaro
Italy	Az. Osp. Monaldi	Naples
Italy	Ospedale Sacro Cuore Don Calabria	Negrar
Italy	Azienda Osp Univ Integrata di Verona	Verona
Netherlands	AMC	Amsterdam
Netherlands	Leiden University Medical Center	Leiden
Netherlands	Universitair Medisch Centrum	Utrecht
Spain	Hospital Clinic de Barcelona	Barcelona
Spain	Hospital de Gran Canaria Dr. Negrin	Las Palmas
Spain	Hospital Universitario Virgen De La Victoria	Málaga
United Kingdom	Belfast City Hospital	Belfast
United Kingdom	Golden Jubilee National Hospital	Clydebank
United Kingdom	Ninewells Hospital and Medical School	Dundee
United Kingdom	Royal Infirmary of Edinburgh	Edinburgh
United Kingdom	South Manchester University Hospital Trust	Manchester
United Kingdom	Northern General Hospital	Sheffield
United Kingdom	New Cross Hospital	Wolverhampton
United States	Abington Memorial Hospital	Abington	Pennsylvania
United States	Albany Medical Center	Albany	New York
United States	Capital Cardiology Associates	Albany	New York
United States	Lehigh Valley Hospital	Allentown	Pennsylvania
United States	Seton Medical Center	Austin	Texas
United States	University of Maryland Medical System	Baltimore	Maryland
United States	Eastern Maine Medical Center	Bangor	Maine
United States	Baptist Medical Center Princeton	Birmingham	Alabama
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Boston Medical Center	Boston	Massachusetts
United States	Providence St. Joseph Medical Center	Burbank	California
United States	Aultman Hospital	Canton	Ohio
United States	University of North Carolina Hospital	Chapel Hill	North Carolina
United States	Erlanger Medical Center	Chattanooga	Tennessee
United States	CorVita Science Foundation (NFP)	Chicago	Illinois
United States	Rush University Medical Center	Chicago	Illinois
United States	The University of Texas, Southwestern Medical Center	Dallas	Texas
United States	St. Luke's Hospital-Duluth	Duluth	Minnesota
United States	Evanston Hospital	Evanston	Illinois
United States	Providence Regional Medical Center Everett	Everett	Washington
United States	Advanced Cardiovascular Clinic	Flint	Michigan
United States	St. Francis Health System - St. Francis Hospital	Greenville	South Carolina
United States	Hattiesburg Clinic, P.A.	Hattiesburg	Mississippi
United States	Heart and Vascular Hattiesburg Clinic	Hattiesburg	Mississippi
United States	St. Mary's Medical Center	Huntington	West Virginia
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa
United States	Baptist Medical Center	Jacksonville	Florida
United States	Cardiology Associates of Northeast Arkansas	Jonesboro	Arkansas
United States	Bronson Methodist Hospital	Kalamazoo	Michigan
United States	University of Kansas Hospital	Kansas City	Kansas
United States	Watson Clinic Center for Research, Inc.	Lakeland	Florida
United States	Mass Heart and Rhythm	Leominster	Massachusetts
United States	Baptist Health Medical Center (Little Rock)	Little Rock	Arkansas
United States	Southern Oregon Cardiology, LLC	Medford	Oregon
United States	Mission Hospital	Mission Viejo	California
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Columbia University Medical Center	New York	New York
United States	Cardiology Physicians, PA	Newark	Delaware
United States	Riverside Regional Medical Center	Newport News	Virginia
United States	Orion Medical	Pasadena	Texas
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	St. Joseph Mercy Hospital Oakland	Pontiac	Missouri
United States	Providence St. Vincent Medical Center	Portland	Oregon
United States	Strong Memorial Hospital of the University of Rochester	Rochester	New York
United States	William Beaumont Hospital	Royal Oak	Michigan
United States	Barnes Jewish Hospital	Saint Louis	Missouri
United States	Regions Hospital	Saint Paul	Minnesota
United States	Sarasota Memorial Hospital	Sarasota	Florida
United States	St. John's Hospital	Springfield	Illinois
United States	Stanford University Medical Center	Stanford	California
United States	Tallahassee Memorial Hospital	Tallahassee	Florida
United States	Harbor UCLA Medical Center	Torrance	California
United States	Torrance Memorial Medical Center	Torrance	California
United States	Christus Trinity Mother Frances Health System	Tyler	Texas
United States	Carle Foundation Hospital	Urbana	Illinois
United States	Florida Hospital	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  Denmark,  France,  Germany,  Hong Kong,  Ireland,  Italy,  Netherlands,  Spain,  United Kingdom, 

References & Publications (8)

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. — View Citation

Benjamin EJ, Blaha MJ, Chiuve SE, Cushman M, Das SR, Deo R, de Ferranti SD, Floyd J, Fornage M, Gillespie C, Isasi CR, Jiménez 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. Review. Erratum in: Circulation. 2017 Mar 7;135(10 ):e646. Circulation. 2017 Sep 5;136(10 ):e196. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Association of HeartLogic sensors with 30-day HF re-admission	To compare a mean sensor value change (admission - discharge) between the no-readmission group and the 30-day readmission group.	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).