Heart FailurePhase 2IPCNCT01370564
Feasibility of an Integrated Patient Care (IPC) System Using Daily Filling Pressures
A Phase 2 study testing Diuretics in people with Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure at 3 sites in United States.
Trial 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… 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?
- Diuretics
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 3 sitesUnited States
- Study dates
- Jun 2011to Jan 2012
- Phase
- Phase 2
- 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
- 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
Who cannot join
- 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)
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Ohio State University
Columbus, Ohio, 43210
Sentara Cardiovascular
Norfolk, Virginia, 23507
Oklahoma Cardiovascular Research
Oklahoma City, Oklahoma, 73120
About this study
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.
Read the 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.
- Conditions
- Heart Failure
- Being tested
- Diuretics
- Keywords
- Heart failure, Cardiac filling pressure
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiureticsDrug
Daily adjustments of diuretics and associated supplements based on cardiac filling pressures.
| Study group | Role | What they receive |
|---|---|---|
| Daily diuretic adjustment | Other | Daily adjustments of diuretics and associated supplements based on cardiac filling pressures. Receives: Drug: Diuretics |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline through Completion/Exit (an average of 3 months)
Secondary outcomes (6)
Characterize the Rate of IPC Setup System Changes
The frequency of changes in the IPC setup during the study (an average of 3-months).
Measured: Baseline through Completion/Exit (an average of 3-months)
Quantify Subject Compliance to Daily PtIS
The proporition of IPC days study subjects indicated they complied with their PtIS.
Measured: Baseline through Completion/Exit (on average 3-months)
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).
Measured: Baseline through Completion/Exit (an average of 3-months)
Summarize Adverse Events
All serious adverse events, cardiovascular adverse events, and event related to the IPC system will be documented and summarized.
Measured: Baseline through Completion/Exit (an average of 3-months)
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).
Measured: Baseline through Completion/Exit (an average of 3-months)
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).
Measured: Baseline through Completion/Exit (an average of 3-months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionDec 2011
- Study completionJan 2012
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.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Medtronic Cardiac Rhythm and Heart FailureThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Philip Adamson, MD, Principal investigator, Oklahoma Cardiovascular Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01370564
- Sponsor's protocol ID
- IPC
- Acronym
- IPC
- Status last verified
- Jun 2018
- First submitted
- 8 Jun 2011
- Last updated
- 11 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of an Integrated Patient Care (IPC) System Using Daily Filling Pressures
- ClinicalTrials.gov ID
- NCT01370564
- Acronym / sponsor ID
- IPC / IPC
- Conditions
- Heart Failure
- Keywords
- Heart failure, Cardiac filling pressure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 10 Jun 2011 (estimated)
- Results
- Posted 11 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Daily diuretic adjustment | Other | Drug: DiureticsDaily adjustments of diuretics and associated supplements based on cardiac filling pressures. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
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 |
|---|---|---|
| DiureticsDaily adjustments of diuretics and associated supplements based on cardiac filling pressures. | Drug | Daily diuretic adjustment |
Primary outcome
Characterize the Technical Feasibility of the Network Based IPC System
Time frame: Baseline through Completion/Exit (an average of 3 months)
The proportion of study days a PtIS is based on the subjects' daily pressure state
6 secondary outcomes
Characterize the Rate of IPC Setup System Changes
Time frame: Baseline through Completion/Exit (an average of 3-months)
Quantify Subject Compliance to Daily PtIS
Time frame: Baseline through Completion/Exit (on average 3-months)
Estimate Changes in Clinical Markers of Heart Failure and Kidney Function
Time frame: Baseline through Completion/Exit (an average of 3-months)
Summarize Adverse Events
Time frame: Baseline through Completion/Exit (an average of 3-months)
Estimate Changes in Clinical Markers of Heart Failure and Kidney Function
Time frame: Baseline through Completion/Exit (an average of 3-months)
Estimate Changes in Clinical Markers of Heart Failure and Kidney Function
Time frame: Baseline through Completion/Exit (an average of 3-months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Philip Adamson, MD principal investigator
Oklahoma Cardiovascular Research
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Diuretics in people with Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure at 3 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 4 inclusion and 8 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: finished, as of the sponsor's last update on 11 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jul 2018). 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?
Characterize the Technical Feasibility of the Network Based IPC System (time frame: Baseline through Completion/Exit (an average of 3 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jul 2018.