Integrated Diagnostics Driven Diuretic and Chronic Medication Management for Heart Failure

NCT02698241 | Terminated Results FDA Device

• 1 other identifier: INTERVENE-HF
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 8

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).

Conditions

Heart Failure

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Effectiveness of the Integrated Diagnostic Medication Intervention Strategy (i.e. Percentage of Implemented Interventions Being Effective)

  The Integrated Diagnostic Medication Intervention Strategy was physician-directed and nurse-implemented and it was based on a heart failure risk score diagnostic feature of a Medtronic CRT-D device implanted in the patients with heart failure. Effectiveness of this intervention strategy was measured as the percentage of implemented interventions being effective. Once initiated, an Integrated Diagnostic Medication Intervention would be effective if all the following criteria were met: 1. The intrathoracic impedance of a subject recovered per defined criterion after completion of the Integrated Diagnostic Medication Intervention; 2. The subject had no HF-related event (as adjudicated by the CEC) during or in the next 14 days after completion of the Integrated Diagnostic Medication Intervention; 3. The subject had not experienced any adverse events that were related to the Integrated Diagnostic Medication Intervention per CEC adjudication and require medical care.

  12 months post enrollment

• Safety of the Integrated Diagnostic and Medication Management (i.e. Percentage of Implemented Interventions Being Safe)

  The Integrated Diagnostic Medication Intervention Strategy was physician-directed and nurse-implemented and it was based on a heart failure risk score diagnostic feature of a Medtronic CRT-D device implanted in the patients with heart failure. Safety of this intervention strategy was measured as the percentage of implemented interventions being safe. Once initiated, the Integrated Diagnostic Medication Intervention Strategy would be regarded as being safe if all the following criteria were met: 1. The Integrated Diagnostic Medication Intervention applied to an episode was not terminated due to safety issues; 2. The Integrated Diagnostic Medication Intervention applied to an episode had not caused treatment-related adverse events (as adjudicated by the CEC).

  12 months post enrollment

Study Arms (1)

Diagnostic & Medication Management

OTHER

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

Device: Diagnostic & Medication Management

Interventions

Diagnostic & Medication Management DEVICE

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

Diagnostic & Medication Management

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

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

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (8)

Phoenix Cardiovascular Research Group, LLC

Phoenix, Arizona, 85018, United States

Location

Florida Heart Center

Ft. Pierce, Florida, 34950, United States

Location

Baptist Heart Specialists Research

Jacksonville, Florida, 32207, United States

Location

First Coast Cardiology

Jacksonville, Florida, 32216, United States

Location

South Miami Heart Specialists

Miami, Florida, 33143, United States

Location

Cardiology Partners

Wellington, Florida, 33449, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

Lindner Research Center

Cincinnati, Ohio, 45219, United States

Location

Related Publications (1)

• 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.

  PMID: 33527654 DERIVED

MeSH Terms

Conditions

Heart Failure

Interventions

Diagnosis

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Limitations and Caveats

Enrollment was stopped after 79 patients were enrolled in the study and the preliminary safety interim data report was completed. The early stop was not due to any safety concerns. The sponsor deemed sufficient data had been collected.

Results Point of Contact

• Title: Joe Hobbs Clinical Research Specialist
• Organization: Medtronic CRHF Clinical Research

joe.hobbs@medtronic.com

800-633-8766

Study Officials

• Eduardo Warman, PhD

  Medtronic

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 29, 2016
• First Posted: March 3, 2016
• Study Start: May 1, 2016
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: December 30, 2019
• Results First Posted: December 9, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)