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Integrated Diagnostics Driven Diuretic and Chronic Medication Management for Heart Failure

Primary Purpose

Heart Failure

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Diagnostic & Medication Management
Sponsored by
Medtronic Cardiac Rhythm and Heart Failure
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Heart Failure focused on measuring Cardiac Resynchronization Therapy Defibrillator (CRT-D), heart failure, integrated diagnostics, chronic medication management

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Phoenix Cardiovascular Research Group, LLC
  • Florida Heart Center
  • Baptist Heart Specialists Research
  • First Coast Cardiology
  • South Miami Heart Specialists
  • Cardiology Partners
  • University of Mississippi Medical Center
  • Lindner Research Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Diagnostic & Medication Management

Arm Description

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

Outcomes

Primary Outcome Measures

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.
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).

Secondary Outcome Measures

Full Information

First Posted
February 29, 2016
Last Updated
December 20, 2019
Sponsor
Medtronic Cardiac Rhythm and Heart Failure
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1. Study Identification

Unique Protocol Identification Number
NCT02698241
Brief Title
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

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Terminated
Study Start Date
May 2016 (Actual)
Primary Completion Date
September 2018 (Actual)
Study Completion Date
September 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Cardiac Rhythm and Heart Failure

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Cardiac Resynchronization Therapy Defibrillator (CRT-D), heart failure, integrated diagnostics, chronic medication management

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
79 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diagnostic & Medication Management
Arm Type
Other
Arm Description
Enrolled subjects will be managed using integrated device diagnostics combined with a clinical medication plan.
Intervention Type
Device
Intervention Name(s)
Diagnostic & Medication Management
Intervention Description
Single Arm Study. Subjects will be managed using integrated diagnostics.
Primary Outcome Measure Information:
Title
Effectiveness of the Integrated Diagnostic Medication Intervention Strategy (i.e. Percentage of Implemented Interventions Being Effective)
Description
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.
Time Frame
12 months post enrollment
Title
Safety of the Integrated Diagnostic and Medication Management (i.e. Percentage of Implemented Interventions Being Safe)
Description
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).
Time Frame
12 months post enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eduardo Warman, PhD
Organizational Affiliation
Medtronic
Official's Role
Study Director
Facility Information:
Facility Name
Phoenix Cardiovascular Research Group, LLC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Facility Name
Florida Heart Center
City
Fort Pierce
State/Province
Florida
ZIP/Postal Code
34950
Country
United States
Facility Name
Baptist Heart Specialists Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
First Coast Cardiology
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
South Miami Heart Specialists
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Cardiology Partners
City
Wellington
State/Province
Florida
ZIP/Postal Code
33449
Country
United States
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Lindner Research Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33527654
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.
Results Reference
derived

Learn more about this trial

Integrated Diagnostics Driven Diuretic and Chronic Medication Management for Heart Failure

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