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

• Sponsor: Boston Scientific Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03579641
• Collaborator: (none)
• Enrollment: 2,184
• Locations: 88
• Actual Duration (Months): 43.1
• Patients Per Site: 24.8
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure; Defibrillators, Implantable; Monitoring, Physiologic; Cardiac Resynchronization Therapy; Cardiovascular Disease; Heart Disease	Device: HeartLogic Sensors

Detailed 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.).

Study Design

• Study Type: Observational
• Actual Enrollment: 2184 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Precision Event Monitoring for Patients With Heart Failure Using HeartLogic: PREEMPT-HF
• Actual Study Start Date: Jun 1, 2018
• Actual Primary Completion Date: Jan 3, 2022
• Actual Study Completion Date: Jan 3, 2022

Arms and Interventions

Arm	Intervention/Treatment
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	Device: HeartLogic Sensors; HeartLogic Sensors

Outcome Measures

Primary Outcome Measures

1. Association of HeartLogic sensors with 30-day HF re-admission [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).]

   To compare a mean sensor value change (admission - discharge) between the no-readmission group and the 30-day readmission group.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Baptist Medical Center Princeton	Birmingham	Alabama	United States	35211
2	University of Alabama at Birmingham	Birmingham	Alabama	United States	35294
3	Cardiology Associates of Northeast Arkansas	Jonesboro	Arkansas	United States	72401
4	Baptist Health Medical Center (Little Rock)	Little Rock	Arkansas	United States	72205
5	Providence St. Joseph Medical Center	Burbank	California	United States	91505
6	Mission Hospital	Mission Viejo	California	United States	92691
7	Stanford University Medical Center	Stanford	California	United States	94305
8	Harbor UCLA Medical Center	Torrance	California	United States	90502
9	Torrance Memorial Medical Center	Torrance	California	United States	90503
10	Cardiology Physicians, PA	Newark	Delaware	United States	19713
11	Baptist Medical Center	Jacksonville	Florida	United States	32207
12	Watson Clinic Center for Research, Inc.	Lakeland	Florida	United States	33805
13	Sarasota Memorial Hospital	Sarasota	Florida	United States	34239
14	Tallahassee Memorial Hospital	Tallahassee	Florida	United States	32308
15	Florida Hospital	Winter Park	Florida	United States	32792
16	CorVita Science Foundation (NFP)	Chicago	Illinois	United States	60605
17	Rush University Medical Center	Chicago	Illinois	United States	60612
18	Evanston Hospital	Evanston	Illinois	United States	60201
19	St. John's Hospital	Springfield	Illinois	United States	62701
20	Carle Foundation Hospital	Urbana	Illinois	United States	61801
21	University of Iowa Hospitals and Clinics	Iowa City	Iowa	United States	52242
22	University of Kansas Hospital	Kansas City	Kansas	United States	66160
23	Eastern Maine Medical Center	Bangor	Maine	United States	04401
24	University of Maryland Medical System	Baltimore	Maryland	United States	21201
25	Boston Medical Center	Boston	Massachusetts	United States	02118
26	Mass Heart and Rhythm	Leominster	Massachusetts	United States	01453
27	Advanced Cardiovascular Clinic	Flint	Michigan	United States	48532
28	Bronson Methodist Hospital	Kalamazoo	Michigan	United States	49007
29	William Beaumont Hospital	Royal Oak	Michigan	United States	48073
30	St. Luke's Hospital-Duluth	Duluth	Minnesota	United States	55805
31	Regions Hospital	Saint Paul	Minnesota	United States	55101
32	Hattiesburg Clinic, P.A.	Hattiesburg	Mississippi	United States	39401
33	Heart and Vascular Hattiesburg Clinic	Hattiesburg	Mississippi	United States	39401
34	St. Joseph Mercy Hospital Oakland	Pontiac	Missouri	United States	48341
35	Barnes Jewish Hospital	Saint Louis	Missouri	United States	63110-1093
36	Albany Medical Center	Albany	New York	United States	12208
37	Capital Cardiology Associates	Albany	New York	United States	12211
38	Columbia University Medical Center	New York	New York	United States	10032
39	Strong Memorial Hospital of the University of Rochester	Rochester	New York	United States	14642
40	University of North Carolina Hospital	Chapel Hill	North Carolina	United States	27599
41	Aultman Hospital	Canton	Ohio	United States	44710
42	Southern Oregon Cardiology, LLC	Medford	Oregon	United States	97504
43	Providence St. Vincent Medical Center	Portland	Oregon	United States	97225
44	Abington Memorial Hospital	Abington	Pennsylvania	United States	19001
45	Lehigh Valley Hospital	Allentown	Pennsylvania	United States	18103
46	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania	United States	15213
47	St. Francis Health System - St. Francis Hospital	Greenville	South Carolina	United States	29607
48	Erlanger Medical Center	Chattanooga	Tennessee	United States	37403
49	Vanderbilt University Medical Center	Nashville	Tennessee	United States	37232-8802
50	Seton Medical Center	Austin	Texas	United States	78705
51	The University of Texas, Southwestern Medical Center	Dallas	Texas	United States	75390-8837
52	Orion Medical	Pasadena	Texas	United States	77505
53	Christus Trinity Mother Frances Health System	Tyler	Texas	United States	75701
54	Riverside Regional Medical Center	Newport News	Virginia	United States	23601
55	Providence Regional Medical Center Everett	Everett	Washington	United States	98201
56	St. Mary's Medical Center	Huntington	West Virginia	United States	25701
57	Prince Charles Hospital	Chermside		Australia
58	OLVZ Aalst	Aalst		Belgium
59	CHUM	Montréal		Canada
60	IUCPQ	Ste-Foy		Canada
61	Aarhus University Hospital	Aarhus		Denmark
62	CHU de Caen	Caen		France
63	CHU de Nantes - Hôpital Laennec	Nantes		France
64	APHP - Hospital de la Pitie-Salpetriere	Paris		France
65	CHU de St. Etienne	Saint-Priest-en-Jarez		France
66	Augusta Kranken Anstalt GmbH - Klinik für Kardiologie und Angiologie	Bochum		Germany
67	Universitaetsklinikum Schleswig-Holstein	Lübeck		Germany
68	Grantham Hospital	Aberdeen		Hong Kong
69	Prince of Wales Hospital	Hong Kong		Hong Kong
70	Queen Mary Hospital	Hong Kong		Hong Kong
71	University Hospital Waterford	Waterford		Ireland
72	Az. Osp. G. Ciaccio Pontepiccolo	Catanzaro		Italy
73	Az. Osp. Monaldi	Naples		Italy
74	Ospedale Sacro Cuore Don Calabria	Negrar		Italy
75	Azienda Osp Univ Integrata di Verona	Verona		Italy
76	AMC	Amsterdam		Netherlands
77	Leiden University Medical Center	Leiden		Netherlands
78	Universitair Medisch Centrum	Utrecht		Netherlands
79	Hospital Clinic de Barcelona	Barcelona		Spain
80	Hospital de Gran Canaria Dr. Negrin	Las Palmas		Spain
81	Hospital Universitario Virgen De La Victoria	Málaga		Spain
82	Belfast City Hospital	Belfast		United Kingdom
83	Golden Jubilee National Hospital	Clydebank		United Kingdom
84	Ninewells Hospital and Medical School	Dundee		United Kingdom
85	Royal Infirmary of Edinburgh	Edinburgh		United Kingdom
86	South Manchester University Hospital Trust	Manchester		United Kingdom
87	Northern General Hospital	Sheffield		United Kingdom
88	New Cross Hospital	Wolverhampton		United Kingdom

Sponsors and Collaborators

• Boston Scientific Corporation

Investigators

• Study Director: Stephen Gaertner, Boston Scientific Corporation

Study Documents (Full-Text)

• Study Protocol - Apr 10, 2018

More Information

Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

• Responsible Party: Boston Scientific Corporation
• ClinicalTrials.gov Identifier: NCT03579641
• Other Study ID Numbers: PREEMPT-HF
• First Posted: Jul 6, 2018
• Last Update Posted: Aug 8, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by Boston Scientific Corporation: Heart Failure; Implantable Cardioverter Defibrillator; Cardiac Resynchronization Therapy Defibrillator; Heart Failure Sensor Data; 30-day Heart Failure Readmission; Ventricular Tachycardia/Ventricular Fibrillation Therapy; Non-Heart Failure Hospitalization; HeartLogic Feature; Latitude Remote Patient Monitor; Data Linkage; Sleep Incline Sensor; Respiratory Sensor; Decongestive Intravenous therapy; Decompensation
• Additional relevant MeSH terms: Heart Failure; Cardiovascular Diseases; Heart Diseases

Study Results

No Results Posted as of Aug 8, 2022