Multiple Cardiac Sensors for the Management of Heart Failure

Completed · Not applicable

Conditions studied: Heart Failure, Congestive

In brief

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.

Key facts

Study ID

NCT03237858

Run by

Boston Scientific Corporation

People needed

200

Starts

2017-08-30

Expected to finish

2020-07-21

Last updated by the study team

2024-03-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Heart Center Research, LLC — Huntsville, Alabama, United States
• Cardiology Associates of Northeast Arkansas — Jonesboro, Arkansas, United States
• University of Southern California Hospital — Los Angeles, California, United States
• Cardiovascular Consultants — Oakland, California, United States
• Sharp Memorial Hospital — San Diego, California, United States
• University of California, San Francisco — San Francisco, California, United States
• University of Colorado — Aurora, Colorado, United States
• Emory University Hospital — Atlanta, Georgia, United States
• Parkview Hospital, Inc. — Fort Wayne, Indiana, United States
• Community Health Network — Indianapolis, Indiana, United States
• Advanced Cardiovascular Specialists — Shreveport, Louisiana, United States
• Centra Care Heart and Vascular Center — Cold Spring, Minnesota, United States
• United Heart and Vascular — Saint Paul, Minnesota, United States
• Catholic Medical Center — Manchester, New Hampshire, United States
• Strong Memorial Hospital of the University of Rochester — Rochester, New York, United States
• Montefiore Medical Center — The Bronx, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Rex Hospital — Raleigh, North Carolina, United States
• Lindner Center for Research and Education at Christ Hosp — Cincinnati, Ohio, United States
• Bethesda North Hospital — Cincinnati, Ohio, United States
• PeaceHealth Sacred Heart Medical Center — Springfield, Oregon, United States
• Penn State Milton S Hershey Medical Center — Hershey, Pennsylvania, United States
• Cardiology Consultants of Philadelphia — Yardley, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Stern Cardiovascular — Germantown, Tennessee, United States

Full record on ClinicalTrials.gov

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