Integrated Diagnostics Driven Diuretic and Chronic Medication Management for Heart Failure

Study Overview
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Brief Summary
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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
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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.

Official Title
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Integrated Diagnostics Driven Diuretic and Chronic Medication Management for Heart Failure

Conditions
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Heart Failure

Intervention / Treatment
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* Device: Diagnostic & Medication Management


Participation Criteria
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Eligibility Criteria
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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: 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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Diagnostic & Medication Management<br>Enrolled subjects will be managed using integrated device diagnostics combined with a clinical medication plan. | Device: Diagnostic & Medication Management<br>* Single Arm Study. Subjects will be managed using integrated diagnostics.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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: The intrathoracic impedance of a subject recovered per defined criterion after completion of the Integrated Diagnostic Medication Intervention; 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; 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: The Integrated Diagnostic Medication Intervention applied to an episode was not terminated due to safety issues; 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac Resynchronization Therapy Defibrillator (CRT-D), heart failure, integrated diagnostics, chronic medication management