Clinical trial NCT01370564: Feasibility of an Integrated Patient Care (IPC) System Using Daily Filling Pressures
Official title: Feasibility of an Integrated Patient Care (IPC) System Using Daily Filling Pressures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Heart Failure
Keywords: Heart failure
Cardiac filling pressure
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2011-06-10
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Characterize the Technical Feasibility of the Network Based IPC System
timeFrame: Baseline through Completion/Exit (an average of 3 months)
Secondary outcomes:
measure: Characterize the Rate of IPC Setup System Changes
timeFrame: Baseline through Completion/Exit (an average of 3-months)
measure: Quantify Subject Compliance to Daily PtIS
timeFrame: Baseline through Completion/Exit (on average 3-months)
measure: Estimate Changes in Clinical Markers of Heart Failure and Kidney Function
timeFrame: Baseline through Completion/Exit (an average of 3-months)
measure: Summarize Adverse Events
timeFrame: Baseline through Completion/Exit (an average of 3-months)
measure: Estimate Changes in Clinical Markers of Heart Failure and Kidney Function
timeFrame: Baseline through Completion/Exit (an average of 3-months)
measure: Estimate Changes in Clinical Markers of Heart Failure and Kidney Function
timeFrame: Baseline through Completion/Exit (an average of 3-months)
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma Cardiovascular Research
state: Oklahoma
city: Norfolk
country: United States
facility: Sentara Cardiovascular
state: Virginia
Study officials:
affiliation: Oklahoma Cardiovascular Research
name: Philip Adamson, MD
role: PRINCIPAL_INVESTIGATOR
References: