Heart FailureNCT02698241

Integrated Diagnostics Driven Diuretic and Chronic Medication Management for Heart Failure

A study testing Diagnostic & Medication Management in people with Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure at 8 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Heart Failure
What is being tested?: Diagnostic & Medication Management
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 79 participants
Where: 8 sitesUnited States
Study dates: May 2016to Sep 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Show all 19Show fewer

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

Who cannot join

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

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

United States8 sites

Lindner Research Center
Cincinnati, Ohio, 45219
Florida Heart Center
Ft. Pierce, Florida, 34950
University of Mississippi Medical Center
Jackson, Mississippi, 39216
Baptist Heart Specialists Research
Jacksonville, Florida, 32207
First Coast Cardiology
Jacksonville, Florida, 32216
South Miami Heart Specialists
Miami, Florida, 33143
Phoenix Cardiovascular Research Group, LLC
Phoenix, Arizona, 85018
Cardiology Partners
Wellington, Florida, 33449

Other trials in United States

About this study

Read the 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
Being tested: Diagnostic & Medication Management
Keywords: Cardiac Resynchronization Therapy Defibrillator (CRT-D), heart failure, integrated diagnostics, chronic medication management
Medical subject headings: Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Diagnostic & Medication ManagementDevice
Single Arm Study. Subjects will be managed using integrated diagnostics.

Study groups in NCT02698241
Study group	Role	What they receive
Diagnostic & Medication Management	Other	Enrolled subjects will be managed using integrated device diagnostics combined with a clinical medication plan. Receives: Device: Diagnostic & Medication Management

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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).
Measured: 12 months post enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2016Sep 2018

First posted3 Mar 2016 (estimated)
Study startMay 2016
Primary completionSep 2018
Study completionSep 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Heart FailureStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 79 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02698241
Sponsor's protocol ID: INTERVENE-HF
Status last verified: Dec 2019
First submitted: 29 Feb 2016
Last updated: 30 Dec 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

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.
PubMed 33527654

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2/3
Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-036)
Heart Failure, Left Ventricular Systolic Dysfunction
RecruitingPhase 1/2
HS235 Study in Overweight and Obese Participants With Combined Pre and Post-Capillary Pulmonary Hypertension Due to Heart Failure With Preserved Ejection Fraction
Pulmonary Hypertension, Heart Failure With Preserved Ejection Fraction
Active, not recruiting
Heart Failure Patient Management and Interventions Using Continuous Patient Monitoring Outside Hospitals and Real-world Data
Chronic Heart Failure, Heart Transplant Recipient
Enrolling by invitationObservational study
Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
Heart Failure
Not yet recruitingObservational study
Real-world Effectiveness and Safety of Savagen (Sacubitril/Valsartan) in Malaysian HFrEF Patients
Heart Failure With Reduced Ejection Fraction (HFrEF), Heart Failure

All Heart Failure trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Integrated Diagnostics Driven Diuretic and Chronic Medication Management for Heart Failure
ClinicalTrials.gov ID: NCT02698241
Acronym / sponsor ID: INTERVENE-HF
Conditions: Heart Failure
Keywords: Cardiac Resynchronization Therapy Defibrillator (CRT-D), heart failure, integrated diagnostics, chronic medication management
Study type: Interventional
Recruitment status: Terminated
Enrolment: 79 participants (actual)
Lead sponsor: Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
Study start: May 2016 (actual)
Primary completion: Sep 2018 (actual)
Study completion: Sep 2018 (actual)
First posted: 3 Mar 2016 (estimated)
Results: Posted 9 Dec 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Diagnostic & Medication Management	Other	Device: Diagnostic & Medication ManagementEnrolled subjects will be managed using integrated device diagnostics combined with a clinical medication plan.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (19 listed)

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

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Diagnostic & Medication ManagementSingle Arm Study. Subjects will be managed using integrated diagnostics.	Device	Diagnostic & Medication Management

Primary outcome

Effectiveness of the Integrated Diagnostic Medication Intervention Strategy (i.e. Percentage of Implemented Interventions Being Effective)
Time frame: 12 months post enrollment
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.
Safety of the Integrated Diagnostic and Medication Management (i.e. Percentage of Implemented Interventions Being Safe)
Time frame: 12 months post enrollment
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).

Results and safety

Results posted to the registry on 9 Dec 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Device Diagnostic & Diuretic and Chronic Medication Management	79	45

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

Time frame: 12 months post enrollment. Number. Unit: percentage of effective interventions

Measure	Device Diagnostic & Diuretic and Chronic Medication Management n = 66
Value	69.2

Population analysed: All subjects who had received the Integrated Diagnostic Medication Intervention per protocol were in the scope of this endpoint analysis. The interest was the effectiveness of the implemented interventions.

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

Time frame: 12 months post enrollment. Number. Unit: percentage of safe interventions

Measure	Device Diagnostic & Diuretic and Chronic Medication Management n = 66
Value	84.6

Adverse events

Time frame: In this study, adverse event data were collected from the time participants signed the informed consent to the time they died or completed the exit visit. The study planned to follow up subjects for 12 months.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Device Diagnostic & Diuretic and Chronic Medication Management	34 of 79 (43%)	13 of 79 (16.5%)	2 of 79

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33527654Zile 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.
Individual participant dataSharing planned: No

Related trials for Heart Failure

RecruitingPhase 2/3
Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-036)
Heart Failure, Left Ventricular Systolic Dysfunction
RecruitingPhase 1/2
HS235 Study in Overweight and Obese Participants With Combined Pre and Post-Capillary Pulmonary Hypertension Due to Heart Failure With Preserved Ejection Fraction
Pulmonary Hypertension, Heart Failure With Preserved Ejection Fraction
Active, not recruiting
Heart Failure Patient Management and Interventions Using Continuous Patient Monitoring Outside Hospitals and Real-world Data
Chronic Heart Failure, Heart Transplant Recipient
Enrolling by invitationObservational study
Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
Heart Failure
Not yet recruitingObservational study
Real-world Effectiveness and Safety of Savagen (Sacubitril/Valsartan) in Malaysian HFrEF Patients
Heart Failure With Reduced Ejection Fraction (HFrEF), Heart Failure

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Eduardo Warman, PhD study director

Medtronic

8 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Diagnostic & Medication Management in people with Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure at 8 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 30 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effectiveness of the Integrated Diagnostic Medication Intervention Strategy (i.e. Percentage of Implemented Interventions Being Effective) (time frame: 12 months post enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02698241, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2019.