Multiple Cardiac Sensors for the Management of Heart Failure

Not Applicable

Completed

• Conditions: Heart Failure, Congestive
• Interventions: Device: HeartLogic OFF; Device: HeartLogic ON

• Registration Number: NCT03237858
• Lead Sponsor: Boston Scientific Corporation

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.

Study Timeline

• Study First Submitted: 2017-07-20
• Study First Submitted QC: 2017-07-31
• Study First Posted: 2017-08-03
• Study Start: 2017-08-30
• Primary Completion: 2020-07-21
• Study Completion: 2020-07-21
• Status Verified: 2023-11
• Results First Submitted: 2023-11-21
• Results First Submitted QC: 2024-02-29
• Last Update Submitted: 2024-02-29
• Results First Posted: 2024-03-27
• Last Update Posted: 2024-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HeartLogic OFF	HeartLogic OFF	ICD and CRT-D devices with HeartLogic alerts turned OFF
HeartLogic ON	HeartLogic ON	ICD and CRT-D devices with HeartLogic alerts turned ON

Primary Outcome Measures

Name	Time	Method
Manage-HF Phase I	Data was collected from the time of consent until the last Phase I subject had completed their 12-month visit	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.

Trial Locations

Locations (30)

Emory University Hospital; 🇺🇸 Atlanta, Georgia, United States

United Heart and Vascular; 🇺🇸 Saint Paul, Minnesota, United States

Sharp Memorial Hospital; 🇺🇸 San Diego, California, United States

Bethesda North Hospital; 🇺🇸 Cincinnati, Ohio, United States

University of California, San Francisco; 🇺🇸 San Francisco, California, United States

University of Colorado; 🇺🇸 Aurora, Colorado, United States

Cardiology Associates of Northeast Arkansas; 🇺🇸 Jonesboro, Arkansas, United States

Heart Center Research, LLC; 🇺🇸 Huntsville, Alabama, United States

University of Southern California Hospital; 🇺🇸 Los Angeles, California, United States

Cardiovascular Consultants; 🇺🇸 Oakland, California, United States

Parkview Hospital, Inc.; 🇺🇸 Fort Wayne, Indiana, United States

Advanced Cardiovascular Specialists; 🇺🇸 Shreveport, Louisiana, United States

Community Health Network; 🇺🇸 Indianapolis, Indiana, United States

Centra Care Heart and Vascular Center; 🇺🇸 Cold Spring, Minnesota, United States

Catholic Medical Center; 🇺🇸 Manchester, New Hampshire, United States

Strong Memorial Hospital of the University of Rochester; 🇺🇸 Rochester, New York, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

PeaceHealth Sacred Heart Medical Center; 🇺🇸 Springfield, Oregon, United States

Rex Hospital; 🇺🇸 Raleigh, North Carolina, United States

Lindner Center for Research and Education at Christ Hosp; 🇺🇸 Cincinnati, Ohio, United States

Stern Cardiovascular; 🇺🇸 Germantown, Tennessee, United States

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States

Penn State Milton S Hershey Medical Center; 🇺🇸 Hershey, Pennsylvania, United States

Cardiology Consultants of Philadelphia; 🇺🇸 Yardley, Pennsylvania, United States

Sentara Norfolk General Hospital; 🇺🇸 Norfolk, Virginia, United States

L'Hôpital privé du Confluent; 🇫🇷 Nantes, France

CHU Pontchaillou; 🇫🇷 Rennes, France

Southeast Texas Clinical Research Center; 🇺🇸 Beaumont, Texas, United States

Universitätsklinikum Würzburg AöR; 🇩🇪 Würzburg, Germany

Montefiore Medical Center; 🇺🇸 Bronx, New York, United States