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

Primary Purpose

Heart Failure, Congestive

Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
HeartLogic ON
HeartLogic OFF
Sponsored by
Boston Scientific Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Heart Failure, Congestive focused on measuring heart failure, diagnostics, heart sounds, CRT-D, ICD, remote monitoring

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Heart Center Research, LLC
  • Cardiology Associates of Northeast Arkansas
  • University of Southern California Hospital
  • Cardiovascular Consultants
  • Sharp Memorial Hospital
  • University of California, San Francisco
  • University of Colorado
  • Emory University Hospital
  • Parkview Hospital, Inc.
  • Community Health Network
  • Advanced Cardiovascular Specialists
  • Centra Care Heart and Vascular Center
  • United Heart and Vascular
  • Catholic Medical Center
  • Montefiore Medical Center
  • Strong Memorial Hospital of the University of Rochester
  • Duke University Medical Center
  • Rex Hospital
  • Lindner Center for Research and Education at Christ Hosp
  • Bethesda North Hospital
  • PeaceHealth Sacred Heart Medical Center
  • Penn State Milton S Hershey Medical Center
  • Cardiology Consultants of Philadelphia
  • Medical University of South Carolina
  • Stern Cardiovascular
  • Southeast Texas Clinical Research Center
  • Sentara Norfolk General Hospital
  • L'Hôpital privé du Confluent
  • CHU Pontchaillou
  • Universitätsklinikum Würzburg AöR

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

HeartLogic ON

HeartLogic OFF

Arm Description

ICD and CRT-D devices with HeartLogic alerts turned ON

ICD and CRT-D devices with HeartLogic alerts turned OFF

Outcomes

Primary Outcome Measures

All cause mortality and heart failure hospitalization
Freedom from all-cause mortality and heart failure hospitalization comparing patients managed with HeartLogic versus those not managed with HeartLogic.

Secondary Outcome Measures

Freedom from all-cause mortality
This endpoint will compare the Kaplan-Meier curves of all-cause survival between the HeartLogic and control groups.
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
Risk of multiple heart failure hospitalizations
This endpoint will compare the cause-specific hazard of heart failure hospitalizations between the HeartLogic and control groups.
Change in NYHA classification
Change in NYHA from baseline through 12 months will be evaluated and compared between the randomized groups.
Change in Quality of Life
Change in Quality of Life from baseline through 12 months will be evaluated and compared between the randomized groups .
Change in NT-proBNP
Change in NT-proBNP from baseline through 12 months will be evaluated and compared between the randomized groups.
Change in Medication Status
Change in medication status throughout the study will be evaluated and compared between the randomized groups.

Full Information

First Posted
July 20, 2017
Last Updated
October 3, 2023
Sponsor
Boston Scientific Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT03237858
Brief Title
Multiple Cardiac Sensors for the Management of Heart Failure
Acronym
MANAGE-HF
Official Title
Multiple Cardiac Sensors for the Management of Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 30, 2017 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
January 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Congestive
Keywords
heart failure, diagnostics, heart sounds, CRT-D, ICD, remote monitoring

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2700 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HeartLogic ON
Arm Type
Active Comparator
Arm Description
ICD and CRT-D devices with HeartLogic alerts turned ON
Arm Title
HeartLogic OFF
Arm Type
Placebo Comparator
Arm Description
ICD and CRT-D devices with HeartLogic alerts turned OFF
Intervention Type
Device
Intervention Name(s)
HeartLogic ON
Intervention Description
Remote management of patients with CRT-D or ICD devices and the HeartLogic diagnostic feature turned OFF
Intervention Type
Device
Intervention Name(s)
HeartLogic OFF
Intervention Description
Remote management of patients with CRT-D or ICD devices and the HeartLogic diagnostic feature turned ON
Primary Outcome Measure Information:
Title
All cause mortality and heart failure hospitalization
Description
Freedom from all-cause mortality and heart failure hospitalization comparing patients managed with HeartLogic versus those not managed with HeartLogic.
Time Frame
From each patients randomization through final endpoint accrual
Secondary Outcome Measure Information:
Title
Freedom from all-cause mortality
Description
This endpoint will compare the Kaplan-Meier curves of all-cause survival between the HeartLogic and control groups.
Time Frame
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.
Title
Freedom from heart failure hospitalizations (time-to-first event)
Description
This endpoint will compare the Kaplan-Meier curves of freedom from heart failure hospitalizations between the HeartLogic and control groups
Time Frame
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
Title
Risk of multiple heart failure hospitalizations
Description
This endpoint will compare the cause-specific hazard of heart failure hospitalizations between the HeartLogic and control groups.
Time Frame
All heart failure hospitalizations following randomization for each subject in Phase II will contribute to the analysis
Title
Change in NYHA classification
Description
Change in NYHA from baseline through 12 months will be evaluated and compared between the randomized groups.
Time Frame
Baseline and 12 months.
Title
Change in Quality of Life
Description
Change in Quality of Life from baseline through 12 months will be evaluated and compared between the randomized groups .
Time Frame
Baseline and 12 months.
Title
Change in NT-proBNP
Description
Change in NT-proBNP from baseline through 12 months will be evaluated and compared between the randomized groups.
Time Frame
Baseline and 12 months.
Title
Change in Medication Status
Description
Change in medication status throughout the study will be evaluated and compared between the randomized groups.
Time Frame
From each patients randomization through final endpoint accrual.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject is age 18 or above, or of legal age to give informed consent Implanted with an cardiac resynchronization therapy defibrillator (CRT-D) or implantable cardioverter-defibrillator (ICD) device that has HeartLogic Current symptomatic heart failure or New York Heart Association Class II or III at the time of enrollment Remotely monitored by LATITUDE 5.0 (or future versions) 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. 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: The subject is unable to sign or refuses to sign the patient informed consent Symptomatic heart failure at rest or New York Heart Association Class IV at the time of enrollment The subject is implanted with unipolar right atrial or right ventricular leads Subject has received or is scheduled to receive a heart transplant or ventricular assist device within the next 6 months Subject is pregnant or planning to become pregnant during the study Subject is enrolled in any other concurrent study (without prior written approval from Boston Scientific, excluding registries) Glomerular filtration rate <25 mL/min who are non-responsive to diuretic therapy or are on chronic renal dialysis Regularly scheduled intravenous heart failure therapy (for example inotropes or diuretics) A life expectancy of less than 12 months per clinician discretion APPLICABLE TO PHASE II ONLY: Subject enrolled in Phase I of MANAGE-HF APPLICABLE TO PHASE II ONLY: Subject has been managed with HeartLogic Alerts ON at anytime within the past 6 months.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adrian Hernandez, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Heart Center Research, LLC
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Cardiology Associates of Northeast Arkansas
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Facility Name
University of Southern California Hospital
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Cardiovascular Consultants
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
Facility Name
Sharp Memorial Hospital
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
University of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Emory University Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Parkview Hospital, Inc.
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46805
Country
United States
Facility Name
Community Health Network
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46250
Country
United States
Facility Name
Advanced Cardiovascular Specialists
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71105
Country
United States
Facility Name
Centra Care Heart and Vascular Center
City
Cold Spring
State/Province
Minnesota
ZIP/Postal Code
56320
Country
United States
Facility Name
United Heart and Vascular
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55102
Country
United States
Facility Name
Catholic Medical Center
City
Manchester
State/Province
New Hampshire
ZIP/Postal Code
03102
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Strong Memorial Hospital of the University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Rex Hospital
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Lindner Center for Research and Education at Christ Hosp
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Bethesda North Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45220
Country
United States
Facility Name
PeaceHealth Sacred Heart Medical Center
City
Springfield
State/Province
Oregon
ZIP/Postal Code
97477
Country
United States
Facility Name
Penn State Milton S Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Cardiology Consultants of Philadelphia
City
Yardley
State/Province
Pennsylvania
ZIP/Postal Code
19067
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Stern Cardiovascular
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Southeast Texas Clinical Research Center
City
Beaumont
State/Province
Texas
ZIP/Postal Code
77702
Country
United States
Facility Name
Sentara Norfolk General Hospital
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
L'Hôpital privé du Confluent
City
Nantes
ZIP/Postal Code
44277
Country
France
Facility Name
CHU Pontchaillou
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
Universitätsklinikum Würzburg AöR
City
Würzburg
ZIP/Postal Code
97080
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35460884
Citation
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.
Results Reference
derived
PubMed Identifier
35129007
Citation
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.
Results Reference
derived

Learn more about this trial

Multiple Cardiac Sensors for the Management of Heart Failure

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