Congestive Heart Failure
Conditions
Keywords
Heart Disease, Congestive Heart Failure, Thoracic Fluid Monitoring
Brief summary
The purpose of the PRECEDE-HF study is to collect data to compare patients whose heart failure is managed using Cardiac Compass with OptiVol (which is a tool in the device that records information about the heart that doctors can use to help treat their heart disease) combined with standard treatment methods (Access Group) to patients whose heart failure is managed by standard treatment methods only (Control Group). This comparison will show if the additional monitoring provided by Cardiac Compass with OptiVol delays the time patients are first admitted to hospital for heart failure or delays the time to death.
Detailed description
PRECEDE-HF was a prospective, multi-center, randomized, investigational device exemption (IDE) clinical study. The purpose of this study was to collect data required to determine whether the use of Cardiac Compass including OptiVol Fluid Status Monitoring with standard clinical assessment (Access Arm) will result in a longer time to first heart failure hospitalization or death compared to standard clinical assessment alone (Control Arm) and to support the approval of the following device features: * OptiVol Alert (audible and home monitor alerts) for use in Medtronic devices * SentryCheck™ Monitor * OptiVol Alert Suspend (OptiVol enhancement) * OptiVol Reference Impedance Adjustment (OptiVol enhancement)
Interventions
DEVICECardiac Compass with OptiVol Fluid Status Monitoring
Review of Cardiac Compass with OptiVol Fluid Status Monitoring
DEVICEStandard of Care alone (clinical assessment)
Clinical assessment utilizing standard of care, alone.
Sponsors
Medtronic Cardiac Rhythm and Heart Failure
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
The following criteria apply to all subjects: * Subject has a CRT-D or dual chamber ICD with Cardiac Compass and OptiVol Fluid Status Monitoring implanted in the pectoral region at least 30 days prior to enrollment. CRT-D/ICD must be supported by the Medtronic CareLink Network. * Subject has a market-released, transvenous, high voltage RV lead * Subject has a market-released RA lead * If subject has an LV lead, it must be compatible, not Y-adapted and not currently under investigation * Subject's heart failure regimen (i.e. beta blocker and ACE inhibitor (or substitute) unless documented evidence of intolerance is available) adheres to current ACC/AHA guidelines for management of chronic heart failure in adult patients * Subject has a history of at least one heart failure related hospitalization, Emergency Department (ED) visit, or urgent visit necessitating IV diuretic, IV inotropic, IV vasodilator, or other parenteral therapy within 12 months prior to baseline evaluation * Subject is at least 18 years of age * Subject is willing and able to comply with the Clinical Investigation Plan (e.g. willing and able to remain available for follow-up visits, use SentryCheck, etc.) * Subject is willing and able to transmit data using the Medtronic CareLink Network * Subject (or subject's legally authorized representative) is willing and able to sign and date the study Informed Consent and HIPAA Authorization (U.S.)
Exclusion criteria
The following criteria apply to all subjects: * Subject is post heart transplant or actively listed on the transplant list and reasonable probability (as defined by investigator) of undergoing transplantation in the next year * Subject received a coronary artery bypass graft or valve surgery in the last 90 days * Subject had a myocardial infarction (MI) in the last 90 days. * Subject is indicated for valve replacement/repair * Subject's life expectancy due to non-cardiac reasons is less than six months * Subject has serum creatinine \> 2.5 mg/dL measured within 30 days prior to enrollment. * Subject is on chronic renal dialysis * Subject is on continuous or intermittent (\> 2 stable infusions per week) infusion therapy for HF * Subject has complex and uncorrected congenital heart disease * Subject is enrolled in a Disease Management Program where an outside vendor, company or service is employed to determine, monitor, and/ or alert a clinician or subject to weight changes or other HF signs or symptoms via interactive or passive systems * Subject is implanted with a cardiac hemodynamic monitor or left ventricular assist device(LVAD) * Subject is enrolled in a concurrent study, with the exception of a study approved by the Medtronic PRECEDE-HF Clinical Trial Leader prior to enrollment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Heart-Failure Hospitalization or All-Cause Death | Up to five years | A composite endpoint of heart-failure hospitalization or all-cause death. To demonstrate a longer time to first heart failure (HF) hospitalization or death in HF subjects managed with standard clinical assessment using Cardiac Compass Trends with OptiVol Fluid Status Monitoring (Access Arm) compared to HF subjects managed with standard clinical assessment alone (Control Arm) |
| Number of Subjects Proportion Who Have a Safety Composite Event Within the First 6 Months Post-randomization Between the Access Arm and the Control Arm | Up to five years | A safety composite event is defined as an event that includes one or more of the following: Syncope, Worsening renal function resulting in IV therapy, ultrafiltration, or dialysis, Hypotension and/or hypovolemia resulting in the administration of IV fluids, Clinically significant electrolyte abnormalities resulting in IV replacement or ER/hospitalization for correction, Appropriately detected sustained VT/VF episode, Death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Combined Endpoint of All-cause Mortality and Cardiovascular Hospitalizations | up to five years | To demonstrate a reduction in the combined endpoint of all-cause mortality and cardiovascular hospitalizations in the Access Arm compared to the Control Arm |
| Cardiovascular Hospitalizations | up to five years | To demonstrate a reduction in cardiovascular hospitalizations in the Access Arm compared to the Control Arm |
Countries
United States
Participant flow
Pre-assignment details
120 subjects were enrolled but 3 were not randomized into the study for not meeting the inclusion/exclusion criteria.
Participants by arm
| Arm | Count |
|---|---|
| Access Arm Standard of Care and Cardiac Compass with OptiVol | 59 |
| Control Arm Standard of Care alone | 58 |
| Total | 117 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 5 | 4 |
Baseline characteristics
| Characteristic | Access Arm | Control Arm | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 38 Participants | 35 Participants | 73 Participants |
| Age, Categorical Between 18 and 65 years | 21 Participants | 23 Participants | 44 Participants |
| Age, Continuous | 65.5 years STANDARD_DEVIATION 17.3 | 63.8 years STANDARD_DEVIATION 15.1 | 64.7 years STANDARD_DEVIATION 16.2 |
| Region of Enrollment United States | 59 participants | 58 participants | 117 participants |
| Sex: Female, Male Female | 13 Participants | 23 Participants | 36 Participants |
| Sex: Female, Male Male | 46 Participants | 35 Participants | 81 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 11 / 59 | 3 / 58 |
| serious Total, serious adverse events | 32 / 59 | 21 / 58 |
Outcome results
Primary
Number of Participants With Heart-Failure Hospitalization or All-Cause Death
A composite endpoint of heart-failure hospitalization or all-cause death. To demonstrate a longer time to first heart failure (HF) hospitalization or death in HF subjects managed with standard clinical assessment using Cardiac Compass Trends with OptiVol Fluid Status Monitoring (Access Arm) compared to HF subjects managed with standard clinical assessment alone (Control Arm)
Time frame: Up to five years
Population: all randomized subjects; intention to treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Access Arm | Number of Participants With Heart-Failure Hospitalization or All-Cause Death | 14 Participants with an Event |
| Control Arm | Number of Participants With Heart-Failure Hospitalization or All-Cause Death | 9 Participants with an Event |
Comparison: This is a log-rank test, which uses the time from randomization to first composite endpoint event to compare the risk of event between Access and Control arms.p-value: 0.23Log Rank
Primary
Number of Subjects Proportion Who Have a Safety Composite Event Within the First 6 Months Post-randomization Between the Access Arm and the Control Arm
A safety composite event is defined as an event that includes one or more of the following: Syncope, Worsening renal function resulting in IV therapy, ultrafiltration, or dialysis, Hypotension and/or hypovolemia resulting in the administration of IV fluids, Clinically significant electrolyte abnormalities resulting in IV replacement or ER/hospitalization for correction, Appropriately detected sustained VT/VF episode, Death
Time frame: Up to five years
Population: all randomized subjects; intention to treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Access Arm | Number of Subjects Proportion Who Have a Safety Composite Event Within the First 6 Months Post-randomization Between the Access Arm and the Control Arm | 16 Number of Participants with a Event |
| Control Arm | Number of Subjects Proportion Who Have a Safety Composite Event Within the First 6 Months Post-randomization Between the Access Arm and the Control Arm | 13 Number of Participants with a Event |
p-value: 0.3695% CI: [-10.9, 20.3]Two-sample test of proportions
Secondary
Cardiovascular Hospitalizations
To demonstrate a reduction in cardiovascular hospitalizations in the Access Arm compared to the Control Arm
Time frame: up to five years
Population: The study was stopped early, therefore secondary objectives were not able to be analyzed.
Secondary
Combined Endpoint of All-cause Mortality and Cardiovascular Hospitalizations
To demonstrate a reduction in the combined endpoint of all-cause mortality and cardiovascular hospitalizations in the Access Arm compared to the Control Arm
Time frame: up to five years
Population: Study was stopped early, therefore secondary objectives were not analyzed.