Multiple Cardiac Sensors for the Management of Heart Failure (MANAGE-HF)

The MANAGE-HF study is a multi-center, global, prospective, open label, multi-phase trial intended to evaluate the clinical efficacy of the HeartLogic heart failure diagnostic feature.

Study Overview

• Status: Completed
• Conditions: Heart Failure, Congestive
• Intervention / Treatment: Device: HeartLogic ON; Device: HeartLogic OFF

Detailed Description

Phase I of the MANAGE-HF trial is not randomized, and is intended to evaluate the clinical integration of HeartLogic for managing patients with heart failure. There are no endpoints.

Phase II of the MANAGE-HF trial will assess the clinical effectiveness of remote monitoring of heart failure patients with implanted CRT-D or ICD cardiac devices that contain the diagnostic feature HeartLogic. This feature uses S1 and S3 heart sounds, night time heart rate, thoracic impedance, and respiration to alert clinicians when a patient's heart failure is worsening. The MANAGE-HF study will compare remote monitoring using HeartLogic alerts to drive heart failure care against patients with remote monitoring but without HeartLogic alerts.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nantes, France, 44277
    • L'Hôpital Privé du Confluent
  • Rennes, France, 35033
    • CHU Pontchaillou
• Germany
  • Würzburg, Germany, 97080
    • Universitätsklinikum Würzburg AÖR
• United States
  • Alabama
    • Huntsville, Alabama, United States, 35801
      • Heart Center Research, LLC
  • Arkansas
    • Jonesboro, Arkansas, United States, 72401
      • Cardiology Associates of Northeast Arkansas
  • California
    • Los Angeles, California, United States, 90033
      • University of Southern California Hospital
    • Oakland, California, United States, 94609
      • Cardiovascular Consultants
    • San Diego, California, United States, 92123
      • Sharp Memorial Hospital
    • San Francisco, California, United States, 94143
      • University of California, San Francisco
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University Hospital
  • Indiana
    • Fort Wayne, Indiana, United States, 46805
      • Parkview Hospital, Inc.
    • Indianapolis, Indiana, United States, 46250
      • Community Health Network
  • Louisiana
    • Shreveport, Louisiana, United States, 71105
      • Advanced Cardiovascular Specialists
  • Minnesota
    • Cold Spring, Minnesota, United States, 56320
      • Centra Care Heart and Vascular Center
    • Saint Paul, Minnesota, United States, 55102
      • United Heart and Vascular
  • New Hampshire
    • Manchester, New Hampshire, United States, 03102
      • Catholic Medical Center
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center
    • Rochester, New York, United States, 14642
      • Strong Memorial Hospital of the University of Rochester
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke University Medical Center
    • Raleigh, North Carolina, United States, 27607
      • Rex Hospital
  • Ohio
    • Cincinnati, Ohio, United States, 45220
      • Bethesda North Hospital
    • Cincinnati, Ohio, United States, 45219
      • Lindner Center for Research and Education at Christ Hosp
  • Oregon
    • Springfield, Oregon, United States, 97477
      • PeaceHealth Sacred Heart Medical Center
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Milton S Hershey Medical Center
    • Yardley, Pennsylvania, United States, 19067
      • Cardiology Consultants of Philadelphia
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
  • Tennessee
    • Germantown, Tennessee, United States, 38138
      • Stern Cardiovascular
  • Texas
    • Beaumont, Texas, United States, 77702
      • Southeast Texas Clinical Research Center
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Sentara Norfolk General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Subject is age 18 or above, or of legal age to give informed consent
2. Implanted with an cardiac resynchronization therapy defibrillator (CRT-D) or implantable cardioverter-defibrillator (ICD) device that has HeartLogic
3. Current symptomatic heart failure or New York Heart Association Class II or III at the time of enrollment
4. Remotely monitored by LATITUDE 5.0 (or future versions)
5. Willing and capable of participating in all study visits and complying with medication/treatment requirements associated with this clinical study at an approved clinical study center.

6. Meet at least one of the three following conditions:

   • At least one documented hospitalization with a primary diagnosis of worsening for heart failure during the 12 months prior to enrollment; or
   • Unscheduled outpatient visit with IV diuretic therapy for acute worsening of HF during 90 days prior to enrollment; or
   • N-terminal-pro brain natriuretic peptide (NT-proBNP) greater than 600 pg/mL or brain natriuretic peptide (BNP) greater than 150 pg/mL at any time during 90 days prior to enrollment

Exclusion Criteria:

1. The subject is unable to sign or refuses to sign the patient informed consent
2. Symptomatic heart failure at rest or New York Heart Association Class IV at the time of enrollment
3. The subject is implanted with unipolar right atrial or right ventricular leads
4. Subject has received or is scheduled to receive a heart transplant or ventricular assist device within the next 6 months
5. Subject is pregnant or planning to become pregnant during the study
6. Subject is enrolled in any other concurrent study (without prior written approval from Boston Scientific, excluding registries)
7. Glomerular filtration rate <25 mL/min who are non-responsive to diuretic therapy or are on chronic renal dialysis
8. Regularly scheduled intravenous heart failure therapy (for example inotropes or diuretics)
9. A life expectancy of less than 12 months per clinician discretion
10. APPLICABLE TO PHASE II ONLY: Subject enrolled in Phase I of MANAGE-HF
11. APPLICABLE TO PHASE II ONLY: Subject has been managed with HeartLogic Alerts ON at anytime within the past 6 months.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: HeartLogic ON; ICD and CRT-D devices with HeartLogic alerts turned ON	Device: HeartLogic ON; Remote management of patients with CRT-D or ICD devices and the HeartLogic diagnostic feature turned OFF
Placebo Comparator: HeartLogic OFF; ICD and CRT-D devices with HeartLogic alerts turned OFF	Device: HeartLogic OFF; Remote management of patients with CRT-D or ICD devices and the HeartLogic diagnostic feature turned ON

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Manage-HF Phase I	Phase-I was a single arm non-randomized study used to evaluate and optimize HeartLogic clinical integration and alert management. Phase-I had no outcome measures.	Data was collected from the time of consent until the last Phase I subject had completed their 12-month visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Freedom from all-cause mortality	This endpoint will compare the Kaplan-Meier curves of all-cause survival between the HeartLogic and control groups.	Subjects that have survived the entire follow-up will be censored at their date of withdrawal, study exit or on the date of the data snapshot, whichever occurs first.
Freedom from heart failure hospitalizations (time-to-first event)	This endpoint will compare the Kaplan-Meier curves of freedom from heart failure hospitalizations between the HeartLogic and control groups	Subjects that have survived without experiencing a heart failure hospitalization at the time of analysis will be censored at their date of withdrawal, study exit or on the date of the data snapshot, whichever occurs first
Risk of multiple heart failure hospitalizations	This endpoint will compare the cause-specific hazard of heart failure hospitalizations between the HeartLogic and control groups.	All heart failure hospitalizations following randomization for each subject in Phase II will contribute to the analysis
Change in NYHA classification	Change in NYHA from baseline through 12 months will be evaluated and compared between the randomized groups.	Baseline and 12 months.
Change in Quality of Life	Change in Quality of Life from baseline through 12 months will be evaluated and compared between the randomized groups .	Baseline and 12 months.
Change in NT-proBNP	Change in NT-proBNP from baseline through 12 months will be evaluated and compared between the randomized groups.	Baseline and 12 months.
Change in Medication Status	Change in medication status throughout the study will be evaluated and compared between the randomized groups.	From each patients randomization through final endpoint accrual.

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Investigators: Principal Investigator: Adrian Hernandez, MD, Duke University

Publications and helpful links

General Publications

• Hernandez AF, Albert NM, Allen LA, Ahmed R, Averina V, Boehmer JP, Cowie MR, Chien CV, Galvao M, Klein L, Kwan B, Lam CSP, Ruble SB, Stolen CM, Stein K; MANAGE-HF Study. Multiple cArdiac seNsors for mAnaGEment of Heart Failure (MANAGE-HF) - Phase I Evaluation of the Integration and Safety of the HeartLogic Multisensor Algorithm in Patients With Heart Failure. J Card Fail. 2022 Aug;28(8):1245-1254. doi: 10.1016/j.cardfail.2022.03.349. Epub 2022 Apr 21.
• Heggermont WA, Van Bockstal K. HeartlogicTM: ready for prime time? Expert Rev Med Devices. 2022 Feb;19(2):107-111. doi: 10.1080/17434440.2022.2038133. Epub 2022 Feb 12. No abstract available.

Helpful Links

• Multiple cArdiac seNsors for mAnaGEment of Heart Failure (MANAGE-HF) - Phase I Evaluation of the Integration and Safety of the HeartLogic Multisensor Algorithm in Patients With Heart Failure

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2017
• Primary Completion (Actual): July 21, 2020
• Study Completion (Actual): July 21, 2020

Study Registration Dates

• First Submitted: July 20, 2017
• First Submitted That Met QC Criteria: July 31, 2017
• First Posted (Actual): August 3, 2017

Study Record Updates

• Last Update Posted (Actual): March 27, 2024
• Last Update Submitted That Met QC Criteria: February 29, 2024
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: heart failure; ICD; remote monitoring; diagnostics; CRT-D; heart sounds
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 92125179

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes