Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03579641
Other study ID # PREEMPT-HF
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


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).
See also
  Status Clinical Trial Phase
Recruiting NCT05650307 - CV Imaging of Metabolic Interventions
Recruiting NCT05654272 - Development of CIRC Technologies
Recruiting NCT05196659 - Collaborative Quality Improvement (C-QIP) Study N/A
Active, not recruiting NCT05896904 - Clinical Comparison of Patients With Transthyretin Cardiac Amyloidosis and Patients With Heart Failure With Reduced Ejection Fraction N/A
Completed NCT05077293 - Building Electronic Tools To Enhance and Reinforce Cardiovascular Recommendations - Heart Failure
Recruiting NCT05631275 - The Role of Bioimpedance Analysis in Patients With Chronic Heart Failure and Systolic Ventricular Dysfunction
Enrolling by invitation NCT05564572 - Randomized Implementation of Routine Patient-Reported Health Status Assessment Among Heart Failure Patients in Stanford Cardiology N/A
Enrolling by invitation NCT05009706 - Self-care in Older Frail Persons With Heart Failure Intervention N/A
Recruiting NCT04177199 - What is the Workload Burden Associated With Using the Triage HF+ Care Pathway?
Terminated NCT03615469 - Building Strength Through Rehabilitation for Heart Failure Patients (BISTRO-STUDY) N/A
Recruiting NCT06340048 - Epicardial Injection of hiPSC-CMs to Treat Severe Chronic Ischemic Heart Failure Phase 1/Phase 2
Recruiting NCT05679713 - Next-generation, Integrative, and Personalized Risk Assessment to Prevent Recurrent Heart Failure Events: the ORACLE Study
Completed NCT04254328 - The Effectiveness of Nintendo Wii Fit and Inspiratory Muscle Training in Older Patients With Heart Failure N/A
Completed NCT03549169 - Decision Making for the Management the Symptoms in Adults of Heart Failure N/A
Recruiting NCT05572814 - Transform: Teaching, Technology, and Teams N/A
Enrolling by invitation NCT05538611 - Effect Evaluation of Chain Quality Control Management on Patients With Heart Failure
Recruiting NCT04262830 - Cancer Therapy Effects on the Heart
Completed NCT06026683 - Conduction System Stimulation to Avoid Left Ventricle Dysfunction N/A
Withdrawn NCT03091998 - Subcu Administration of CD-NP in Heart Failure Patients With Left Ventricular Assist Device Support Phase 1
Recruiting NCT05564689 - Absolute Coronary Flow in Patients With Heart Failure With Reduced Ejection Fraction and Left Bundle Branch Block With Cardiac Resynchronization Therapy