Integrated Diagnostics Driven Diuretic and Chronic Medication Management for Heart Failure

Stopped early · Not applicable

Conditions studied: Heart Failure

In brief

The INTERVENE-HF study is a prospective, non-randomized, multi-center (US only), investigational, feasibility study. The purpose of this study is to characterize safety of managing heart failure patients with integrated device diagnostics that have an implanted commercially available Medtronic cardiac resynchronization therapy defibrillator (CRT-D).

Key facts

Study ID

NCT02698241

Run by

Medtronic Cardiac Rhythm and Heart Failure

People needed

79

Starts

2016-05-01

Expected to finish

2018-09-01

Last updated by the study team

2019-12-30

Who can join

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

You may qualify if…

• Subject (or subject's legally authorized representative) is willing and able to provide written informed consent
• Subject has been implanted with a CRT device for at least 9 months and has had a wireless Medtronic CRT-D device for at least 34 days
• Subject has >1 year life expectancy
• Subject's CRT-D device has at least 18 months of device longevity left
• Subject has an eGFR> 25 ml/min/1.73 m2
• Subject is NYHA Class II or III
• Subject is NYHA Class II or III • Subject has elevated BNP values (BNP>400 or NTpro BNP>800) within the last 3 months OR Subject has had at least one OptiVol threshold crossing in the last 9 months OR Subject has had a HF event within the last 9 months
• HF event is defined as meeting any one of the following two criteria:
• Subject was admitted to the hospital for worsening HF OR
• Subject has received Intravenous HF therapy (e.g. IV diuretics/vasodilators) or ultrafiltration at any settings including:
• Emergency Department
• Ambulance
• Observation Unit
• Urgent Care
• HF/Cardiology Clinic
• Patient's Home
• Subjects who are currently prescribed and taking medications for the management of heart failure and are able to tolerate transient increases in diuretic dosage
• Subject is willing and able to comply with the protocol, including screening, baseline and programming visit(s), remote care directions, follow-up visits, and exit visit
• Subject can send device transmissions and daily biometric data with in-home patient devices

You may not qualify if…

• Subject has systolic BP of < 90 mmHg at the time of enrollment
• Subject not responsive to diuretic therapy or is on chronic renal dialysis
• Subject unable to undergo one round of medication intervention (3 day up-titration of diuretic) without requiring safety check
• Subjects enrolled in a concurrent study that may confound the results of this study without documented pre-approval from a Medtronic study manager
• Subject weighs more than 500 pounds
• Subject is younger than 18 years of age
• Subject has hemodynamic monitoring device implanted

Where it is running

• Phoenix Cardiovascular Research Group, LLC — Phoenix, Arizona, United States
• Florida Heart Center — Ft. Pierce, Florida, United States
• Baptist Heart Specialists Research — Jacksonville, Florida, United States
• First Coast Cardiology — Jacksonville, Florida, United States
• South Miami Heart Specialists — Miami, Florida, United States
• Cardiology Partners — Wellington, Florida, United States
• University of Mississippi Medical Center — Jackson, Mississippi, United States
• Lindner Research Center — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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