Heart Failure
Conditions
Keywords
Heart failure, Cardiac filling pressure
Brief summary
This chronic, prospective, non-randomized feasibility study is designed to evaluate the Integrated Patient Care (IPC) concept in subjects who already have either a Medtronic Chronicle Implantable Hemodynamic Monitor (IHM) or Chronicle Implantable Cardioverter Defibrillator (ICD) device implanted, and are currently enrolled in the Chronicle Offers Management to Patients with Advanced Signs & Symptoms of Heart Failure (COMPASS-HF) Extension Phase Study (IDE # G020304). The purpose of the study is to use daily cardiac filling pressures from the Chronicle device to provide timely medication adjustments (diuretics) to subjects.
Detailed description
Subjects will be asked to transmit to the CareLink Network daily. Data specific to this study (subject's daily estimated Pulmonary Arterial Diastolic (ePAD) pressure values) will be extracted from the CareLink database and transferred to the IPC clinician website. As each subject is enrolled, clinicians at each participating site will determine the appropriate target pressure range for each subject based on a review of the subject's pressure data. Each day after enrollment, the subject's current pressure data will be compared to a target pressure range that the clinician sets for that subject. The patient instruction set (PtIS) is limited to a daily diuretic prescription and associated supplements, per physician discretion. The PtIS should not include adjustments of non-heart failure medications and should not include heart failure medications that are not indicated for day-to-day adjustments (e.g. ACE-Inhibitors, Angiotensin Receptor Blockers (ARBs), and Beta-Blockers). The PtIS will be sent from the IPC clinician website to the subject through a Patient Home Monitor.
Interventions
DRUGDiuretics
Daily adjustments of diuretics and associated supplements based on cardiac filling pressures.
Sponsors
Medtronic Cardiac Rhythm and Heart Failure
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients implanted with a Chronicle IHM device (Model 9520, Model 9520B) or Chronicle ICD device (Model 7286) * Patients who have been prescribed daily diuretic therapy for the management of heart failure * Patients currently participating in the COMPASS-HF Extension Phase Study (IDE #G020304) * Patients willing and able to give informed consent
Exclusion criteria
* Patients with non-physiologic Right Ventricular (RV) pressure values * Patients who have diuretic resistance * Patients who have an estimated Glomerular Filtration Rate(eGFR) \<30 ml/min (recorded within the last six months) * Patients who have a Chronicle IHM device (Model 9520) that was implanted as part of the Pulmonary Arterial Hypertension (PAH) Pilot Study (IDE #G020303) * Patients who do not have the ability to actively participate in the management of their own heart failure care (determine by physician discretion)(e.g. patient does not have ability to operate study equipment, patient does not have a history of compliance to sending CareLink transmissions) * Patients who have a reasonable probability of needing a device replacement during the study (approximately two months) * Patients enrolled or planning to participate in a concurrent drug and/or device study during the course of this clinical trial * Patient who are pregnant (all females of child-bearing potential must have a negative pregnancy test within 1 week of enrollment)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Characterize the Technical Feasibility of the Network Based IPC System | Baseline through Completion/Exit (an average of 3 months) | The proportion of study days a PtIS is based on the subjects' daily pressure state |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Characterize the Rate of IPC Setup System Changes | Baseline through Completion/Exit (an average of 3-months) | The frequency of changes in the IPC setup during the study (an average of 3-months). |
| Quantify Subject Compliance to Daily PtIS | Baseline through Completion/Exit (on average 3-months) | The proporition of IPC days study subjects indicated they complied with their PtIS. |
| Estimate Changes in Clinical Markers of Heart Failure and Kidney Function | Baseline through Completion/Exit (an average of 3-months) | Changes in brain natriuretic peptide from baseline to study exit (an average of 3-months). |
| Summarize Adverse Events | Baseline through Completion/Exit (an average of 3-months) | All serious adverse events, cardiovascular adverse events, and event related to the IPC system will be documented and summarized. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Daily Diuretic Adjustment Daily adjustments of diuretics and associated supplements based on cardiac filling pressures.
Diuretics: Daily adjustments of diuretics and associated supplements based on cardiac filling pressures. | 21 |
| Total | 21 |
Baseline characteristics
| Characteristic | Daily Diuretic Adjustment |
|---|---|
| Age, Continuous | 59.2 years STANDARD_DEVIATION 12.7 |
| New York Heart Association Classification Class I | 4 Participants |
| New York Heart Association Classification Class II | 12 Participants |
| New York Heart Association Classification Class III | 5 Participants |
| New York Heart Association Classification Class IV | 0 Participants |
| Region of Enrollment United States | 21 participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 21 |
| other Total, other adverse events | 4 / 21 |
| serious Total, serious adverse events | 2 / 21 |
Outcome results
Primary
Characterize the Technical Feasibility of the Network Based IPC System
The proportion of study days a PtIS is based on the subjects' daily pressure state
Time frame: Baseline through Completion/Exit (an average of 3 months)
Population: The analysis population is the total number of study participants. For each study subject, the number of days in which the IPC system delivered a patient instruction set based on the subject's pressure state as measured by the Chronicle ICD/IHM pressure sensor.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Daily Diuretic Adjustment | Characterize the Technical Feasibility of the Network Based IPC System | 72 percentage of days |
95% CI: [65, 78]
Secondary
Characterize the Rate of IPC Setup System Changes
The frequency of changes in the IPC setup during the study (an average of 3-months).
Time frame: Baseline through Completion/Exit (an average of 3-months)
Population: The analysis population is the total number of study participants. For each study subject, the number of changes to the IPC setup were obtained
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Daily Diuretic Adjustment | Characterize the Rate of IPC Setup System Changes | 0.2 changes per day |
Secondary
Estimate Changes in Clinical Markers of Heart Failure and Kidney Function
Changes in brain natriuretic peptide from baseline to study exit (an average of 3-months).
Time frame: Baseline through Completion/Exit (an average of 3-months)
Population: Subjects with brain natriuretic peptide values at baseline and study completion (3-month visit) visits
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Daily Diuretic Adjustment | Estimate Changes in Clinical Markers of Heart Failure and Kidney Function | -44.4 pg/dL | Standard Deviation 388.8 |
Secondary
Estimate Changes in Clinical Markers of Heart Failure and Kidney Function
Changes in estimated glomular filtration rate from baseline to study exit (an average of 3-months).
Time frame: Baseline through Completion/Exit (an average of 3-months)
Population: Subjects with lestimated glomular filtration rate values available at the baseline and study exit (3-month) visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Daily Diuretic Adjustment | Estimate Changes in Clinical Markers of Heart Failure and Kidney Function | 0 mL/min per 1.73 m^2 | Standard Deviation 14.2 |
Secondary
Estimate Changes in Clinical Markers of Heart Failure and Kidney Function
Changes in blood urea nitrogen from baseline to study exit (an average of 3-months).
Time frame: Baseline through Completion/Exit (an average of 3-months)
Population: Subjects with blood urea nitrogen values at both the baseline and study exit visits
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Daily Diuretic Adjustment | Estimate Changes in Clinical Markers of Heart Failure and Kidney Function | 1 mg/dL | Standard Deviation 6.2 |
Secondary
Quantify Subject Compliance to Daily PtIS
The proporition of IPC days study subjects indicated they complied with their PtIS.
Time frame: Baseline through Completion/Exit (on average 3-months)
Population: The analysis population is the total number of study participants. For each study subject, the number of days in which the subject indicated that they followed their PtIS
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Daily Diuretic Adjustment | Quantify Subject Compliance to Daily PtIS | 0.994 proportion of compliant days |
Secondary
Summarize Adverse Events
All serious adverse events, cardiovascular adverse events, and event related to the IPC system will be documented and summarized.
Time frame: Baseline through Completion/Exit (an average of 3-months)
Population: All 21 subjects participating in the IPC study
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Daily Diuretic Adjustment | Summarize Adverse Events | Cardiovascular Related Adverse Event | No | 18 Participants |
| Daily Diuretic Adjustment | Summarize Adverse Events | Serious Adverse Event | Yes | 2 Participants |
| Daily Diuretic Adjustment | Summarize Adverse Events | Serious Adverse Event | No | 19 Participants |
| Daily Diuretic Adjustment | Summarize Adverse Events | IPC Related Adverse Events | Yes | 0 Participants |
| Daily Diuretic Adjustment | Summarize Adverse Events | IPC Related Adverse Events | No | 21 Participants |
| Daily Diuretic Adjustment | Summarize Adverse Events | PtIS Related Adverse Events | Yes | 0 Participants |
| Daily Diuretic Adjustment | Summarize Adverse Events | PtIS Related Adverse Events | No | 21 Participants |
| Daily Diuretic Adjustment | Summarize Adverse Events | Heart Failure Related Adverse Event | Yes | 2 Participants |
| Daily Diuretic Adjustment | Summarize Adverse Events | Heart Failure Related Adverse Event | No | 19 Participants |
| Daily Diuretic Adjustment | Summarize Adverse Events | Cardiovascular Related Adverse Event | Yes | 3 Participants |