Multiple Cardiac Sensors for the Management of Heart Failure

Heart Failure, Congestive Clinical Trial

— MANAGE-HF  

Official title:

Multiple Cardiac Sensors for the Management of Heart Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03237858
• Other study ID #: 92125179
• Status: Completed
• Phase: N/A
• Start date: August 30, 2017
• Est. completion date: July 21, 2020

Study information

• Verified date: November 2023
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: July 21, 2020
• Est. primary completion date: July 21, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure, Congestive

Intervention

Device:
• HeartLogic ON
Remote management of patients with CRT-D or ICD devices and the HeartLogic diagnostic feature turned OFF
• HeartLogic OFF
Remote management of patients with CRT-D or ICD devices and the HeartLogic diagnostic feature turned ON

Locations

Country	Name	City	State
France	L'Hôpital privé du Confluent	Nantes
France	CHU Pontchaillou	Rennes
Germany	Universitätsklinikum Würzburg AöR	Würzburg
United States	Emory University Hospital	Atlanta	Georgia
United States	University of Colorado	Aurora	Colorado
United States	Southeast Texas Clinical Research Center	Beaumont	Texas
United States	Montefiore Medical Center	Bronx	New York
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Bethesda North Hospital	Cincinnati	Ohio
United States	Lindner Center for Research and Education at Christ Hosp	Cincinnati	Ohio
United States	Centra Care Heart and Vascular Center	Cold Spring	Minnesota
United States	Duke University Medical Center	Durham	North Carolina
United States	Parkview Hospital, Inc.	Fort Wayne	Indiana
United States	Stern Cardiovascular	Germantown	Tennessee
United States	Penn State Milton S Hershey Medical Center	Hershey	Pennsylvania
United States	Heart Center Research, LLC	Huntsville	Alabama
United States	Community Health Network	Indianapolis	Indiana
United States	Cardiology Associates of Northeast Arkansas	Jonesboro	Arkansas
United States	University of Southern California Hospital	Los Angeles	California
United States	Catholic Medical Center	Manchester	New Hampshire
United States	Sentara Norfolk General Hospital	Norfolk	Virginia
United States	Cardiovascular Consultants	Oakland	California
United States	Rex Hospital	Raleigh	North Carolina
United States	Strong Memorial Hospital of the University of Rochester	Rochester	New York
United States	United Heart and Vascular	Saint Paul	Minnesota
United States	Sharp Memorial Hospital	San Diego	California
United States	University of California, San Francisco	San Francisco	California
United States	Advanced Cardiovascular Specialists	Shreveport	Louisiana
United States	PeaceHealth Sacred Heart Medical Center	Springfield	Oregon
United States	Cardiology Consultants of Philadelphia	Yardley	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Countries where clinical trial is conducted

United States,  France,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External 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