Clinical trial NCT02698241: Integrated Diagnostics Driven Diuretic and Chronic Medication Management for Heart Failure
Official title: Integrated Diagnostics Driven Diuretic and Chronic Medication Management for Heart Failure
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Heart Failure
Keywords: Cardiac Resynchronization Therapy Defibrillator (CRT-D)
heart failure
integrated diagnostics
chronic medication management
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2016-03-03
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Effectiveness of the Integrated Diagnostic Medication Intervention Strategy (i.e. Percentage of Implemented Interventions Being Effective)
timeFrame: 12 months post enrollment
measure: Safety of the Integrated Diagnostic and Medication Management (i.e. Percentage of Implemented Interventions Being Safe)
timeFrame: 12 months post enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Phoenix Cardiovascular Research Group, LLC
state: Arizona
city: Fort Pierce
country: United States
facility: Florida Heart Center
state: Florida
city: Jacksonville
country: United States
facility: Baptist Heart Specialists Research
state: Florida
city: Jacksonville
country: United States
facility: First Coast Cardiology
state: Florida
city: Miami
country: United States
facility: South Miami Heart Specialists
state: Florida
city: Wellington
country: United States
facility: Cardiology Partners
state: Florida
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Cincinnati
country: United States
facility: Lindner Research Center
state: Ohio
Study officials:
affiliation: Medtronic
name: Eduardo Warman, PhD
role: STUDY_DIRECTOR
References:
citation: 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.