Integrated Diagnostics Driven Diuretic and Chronic Medication Management for Heart Failure

NCT ID: NCT02698241

Last Updated: 2019-12-30

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 79 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2018-09-30

Brief Summary

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).

Detailed Description

The study is expected to be conducted at up to 20 centers located in the United States. Up to 400 subjects will be enrolled to yield up to 200 eligible subjects that meet screening criteria. This study will be conducted in subjects with an implanted, commercially available, Medtronic, CRT-D device. Each enrolled subject will be followed every 2 months from time of enrollment to end of the study.The study will end after the last enrolled subject completes the 12-month follow-up.

Conditions

Heart Failure

Keywords

Cardiac Resynchronization Therapy Defibrillator (CRT-D); heart failure; integrated diagnostics; chronic medication management

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Diagnostic & Medication Management

Enrolled subjects will be managed using integrated device diagnostics combined with a clinical medication plan.

Group Type: OTHER

Diagnostic & Medication Management

Intervention Type: DEVICE

Single Arm Study. Subjects will be managed using integrated diagnostics.

Interventions

Diagnostic & Medication Management

Single Arm Study. Subjects will be managed using integrated diagnostics.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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:

1. Subject was admitted to the hospital for worsening HF OR

2. 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Cardiac Rhythm and Heart Failure

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eduardo Warman, PhD

Role: STUDY_DIRECTOR

Medtronic

Locations

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

Countries

United States

References

Zile MR, Costanzo MRR, Ippolito EM, Zhang Y, Stapleton R, Sadhu A, Jimenez J, Hobbs J, Sharma V, Warman EN, Streeter L, Butler J. INTERVENE-HF: feasibility study of individualized, risk stratification-based, medication intervention in patients with heart failure with reduced ejection fraction. ESC Heart Fail. 2021 Apr;8(2):849-860. doi: 10.1002/ehf2.13231. Epub 2021 Feb 1.

Reference Type: DERIVED

PMID: 33527654 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

INTERVENE-HF

Identifier Type: -

Identifier Source: org_study_id