Heart Failure
Conditions
Keywords
Cardiac Resynchronization Therapy Defibrillator (CRT-D), heart failure, integrated diagnostics, chronic medication management
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.
Interventions
DEVICEDiagnostic & Medication Management
Single Arm Study. Subjects will be managed using integrated diagnostics.
Sponsors
Medtronic Cardiac Rhythm and Heart Failure
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness of the Integrated Diagnostic Medication Intervention Strategy (i.e. Percentage of Implemented Interventions Being Effective) | 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) | 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). |
Countries
United States
Participant flow
Pre-assignment details
A screening visit was required after a subject signed the informed consent form and before the baseline and programming visit. During the screening visit, subject's OptiVol Fluid Index and bloodwork were verified for the eligibility to continue the study. If subject failed the screening, he/she would exit the study.
Participants by arm
| Arm | Count |
|---|---|
| Device Diagnostic & Diuretic and Chronic Medication Management Enrolled subjects will be managed using integrated device diagnostics combined with a clinical medication plan. This is a single arm feasibility study. | 66 |
| Total | 66 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 2 |
| Overall Study | geographic and licensing issue | 1 |
| Overall Study | Inclusion/exclusion criteria not met | 4 |
| Overall Study | Lost to Follow-up | 3 |
| Overall Study | Physician Decision | 2 |
| Overall Study | Screening not met | 7 |
| Overall Study | Subject on inodrip not safe to continue | 6 |
| Overall Study | Subject underwent system modification | 2 |
| Overall Study | Withdrawal by Subject | 7 |
Baseline characteristics
| Characteristic | Device Diagnostic & Diuretic and Chronic Medication Management |
|---|---|
| Age, Continuous | 72.9 years STANDARD_DEVIATION 9.1 |
| BMI | 28.1 kg/m^2 STANDARD_DEVIATION 6.4 |
| Diastolic BP | 70.6 mmHg STANDARD_DEVIATION 9.4 |
| Having heart failure events in previous 6 months No | 53 Participants |
| Having heart failure events in previous 6 months Yes | 13 Participants |
| NYHA Class Class I | 0 Participants |
| NYHA Class Class II | 27 Participants |
| NYHA Class Class III | 39 Participants |
| NYHA Class Class IV | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 57 Participants |
| Region of Enrollment United States | 66 participants |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 46 Participants |
| Systolic BP | 119.6 mmHg STANDARD_DEVIATION 17.7 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 79 |
| other Total, other adverse events | 13 / 79 |
| serious Total, serious adverse events | 34 / 79 |
Outcome results
Primary
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.
Time frame: 12 months post enrollment
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Device Diagnostic & Diuretic and Chronic Medication Management | Effectiveness of the Integrated Diagnostic Medication Intervention Strategy (i.e. Percentage of Implemented Interventions Being Effective) | 69.2 percentage of effective interventions |
Primary
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).
Time frame: 12 months post enrollment
Population: All subjects who had received the Integrated Diagnostic Medication Intervention per protocol were in the scope of this endpoint analysis. The interest was the safety of implemented interventions
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Device Diagnostic & Diuretic and Chronic Medication Management | Safety of the Integrated Diagnostic and Medication Management (i.e. Percentage of Implemented Interventions Being Safe) | 84.6 percentage of safe interventions |