Heart FailureHOMEOSTASISNCT00547729
Hemodynamically Guided Home Self-Therapy in Severe Heart Failure Patients (HOMEOSTASIS)
A study testing HeartPOD™ System in people with Heart Failure, run by Abbott Medical Devices at 7 sites in 3 countries.
Trial summary
This study is a feasibility study of the HeartPOD™ Heart Failure Management System with DynamicRx® (HeartPOD system) in patients with severe chronic congestive heart failure. The device being studied in this trial monitors heart function and alerts the patient and physician of necessary changes to medication. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- HeartPOD™ System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 7 sitesin 3 countries
- Study dates
- Mar 2005to Jun 2008
- Phase
- Interventional
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 and < 85.
- Documented history of congestive heart failure resulting from ischemic or non-ischemic cardiomyopathy with systolic or diastolic dysfunction of at least 6 months duration.
- Patients with LVEF < 40% should receive maximally tolerated doses of ACE-I (or ARB if ACE-I is not tolerated), beta blockers, and anti-aldosterone therapy. The combination of hydralazine and nitrates should be considered in the persistently symptomatic African American patient.
- A history of NYHA Class II (OUS only), III or IV symptoms.
- Minimum of one (1) prior hospital admission within the last 12 months for exacerbation of CHF or one (1) presentation to the Emergency Department or Clinic requiring parenteral diuretic, vasodilator, inotrope, nesiritide, or equivalent treatment.
- Female subjects of childbearing potential must have a negative pregnancy test within seven (7) days before the procedure.
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- Central venous vascular access.
- Capable of Valsalva maneuver with airway pressure > 40 mm Hg for 10 seconds.
- The subject and the treating physician agree that the subject will comply with all required post-procedure follow-up, and that the patient is capable of correct device use as outlined in the protocol.
- Written informed consent.
Who cannot join
- Intractable HF with resting symptoms despite maximal medical therapy or active listing for cardiac transplantation (< 6 months survival expected).
- Resting systolic blood pressure < 90 or > 180 mmHg.
- Acute MI, unstable ischemic syndrome within the last 6 weeks.
- Percutaneous coronary intervention (PCI) or cardiac surgery performed or planned within 6 weeks.
- Coexisting stenotic valve lesions, vegetations, hypertrophic cardiomyopathy, amyloidosis or other infiltrative heart disease, constrictive, restrictive disease, tamponade, or moderate or large pericardial effusion.
- Subject has a history of deep venous thrombosis or pulmonary embolism.
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- Surgical correction of congenital heart disease involving atrial septum.
- CVA or TIA within 6 months. History of uncorrected cerebral vascular disease.
- Atrial or ventricular thrombus, tumor or systemic thromboembolism.
- Chronic atrial fibrillation.
- Symptomatic bradyarrhythmia or sustained VT/VF unless successfully treated with cardiac rhythm management device for 6 weeks.
- Atrial septal defect or patent foramen ovale > 2 mm in diameter.
- Life expectancy < 1 year from malignancy, primary pulmonary hypertension, renal, hepatic, or neurological condition, etc.
- Gastrointestinal bleeding during the last 6 months.
- Coagulopathy or uninterruptible anticoagulation therapy or unable to take antiplatelet medications.
- Creatinine > 2.5 gm/dl
- Temperature > 37.8C or white blood cell count (WBC) > 13,000/mm3.
- The subject is currently participating in an investigational drug or another device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints.
Trial locations and contacts
7 sites in 3 countries.
7 sites in 3 countries
United States4 sites
The Ohio State University
Columbus, Ohio, 43210
Scripps Green Hospital
La Jolla, California, 92037
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Oklahoma Heart Hospital
Oklahoma City, Oklahoma, 73120
New Zealand2 sites
University of Auckland
Auckland
Christchurch Hospital
Christchurch
About this study
Official title: Hemodynamically Guided Home Self-Therapy in Severe Heart Failure Patients: A Prospective, Multi-center, Non-randomized, Open Label Study.
This study is a feasibility study of the HeartPOD™ Heart Failure Management System with DynamicRx® (HeartPOD system) in patients with severe chronic congestive heart failure. The device being studied in this trial monitors heart function and alerts the patient and physician of necessary changes to medication. The study will assess the safety, reliability, and preliminary efficacy of the HeartPOD™ system.
Read the detailed description
Direct cardiac measurements may provide an accurate, reliable and medically acceptable way of informing patients and physicians of worsening CHF prior to the development of symptoms. This may enable physicians to take preventative measures and avoid hospitalization.
This is a feasibility study to assess the safety, reliability, and preliminary efficacy of the HeartPOD™ Heart Failure Management System with DynamicRx®. This feasibility study will be performed in two phases. The first phase will enroll 20 patients at sites in Australia and New Zealand and the second phase will enroll 20 patients at sites in the U.S.
- Conditions
- Heart Failure
- Being tested
- HeartPOD™ System
- Keywords
- Heart Failure, Left Atrial Pressure Monitoring
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HeartPOD™ SystemDevice
HeartPOD™ device with DynamicRx® automatically measures left heart pressures throughout the day.
| Study group | Role | What they receive |
|---|---|---|
| HeartPOD™ System | Experimental | Implantation of HeartPOD™ Heart Failure Management System with DynamicRx® Receives: Device: HeartPOD™ System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients Free From Major Adverse Cardiac and Neurological Events (MACNE) at 6 Weeks.
Out of 71 subjects enrolled, data from 55 subjects was adjudicated by a Clinical Events Committee and included in this primary endpoint analysis. MACNE was defined as a hierarchical composite of cardiovascular related death, myocardial infarction, systemic thromboembolism and stroke.
Measured: 6 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2007 (estimated)
- Study startMar 2005
- Primary completionJun 2008
- Study completionJun 2008
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.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- William T. Abraham, MD, FACC, Study chair, Ohio State UniversityHenry Krum, MD, Principal investigator, Monash University/Alfred Hosptial
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00547729
- Sponsor's protocol ID
- HP-05-04/HP-12-04
- Acronym
- HOMEOSTASIS
- Status last verified
- Aug 2021
- First submitted
- 19 Oct 2007
- Last updated
- 2 Sep 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Ritzema J, Melton IC, Richards AM, Crozier IG, Frampton C, Doughty RN, Whiting J, Kar S, Eigler N, Krum H, Abraham WT, Troughton RW. Direct left atrial pressure monitoring in ambulatory heart failure patients: initial experience with a new permanent implantable device. Circulation. 2007 Dec 18;116(25):2952-9. doi: 10.1161/CIRCULATIONAHA.107.702191. Epub 2007 Dec 3.
PubMed 18056531Pretorius V, Birgersdotter-Green U, Heywood JT, Hafelfinger W, Gutfinger DE, Eigler NL, Love CJ, Abraham WT. An implantable left atrial pressure sensor lead designed for percutaneous extraction using standard techniques. Pacing Clin Electrophysiol. 2013 May;36(5):570-7. doi: 10.1111/pace.12111. Epub 2013 Feb 28.
PubMed 23448187Ritzema JL, Richards AM, Crozier IG, Frampton CF, Melton IC, Doughty RN, Stewart JT, Eigler N, Whiting J, Abraham WT, Troughton RW. Serial Doppler echocardiography and tissue Doppler imaging in the detection of elevated directly measured left atrial pressure in ambulant subjects with chronic heart failure. JACC Cardiovasc Imaging. 2011 Sep;4(9):927-34. doi: 10.1016/j.jcmg.2011.07.004.
PubMed 21920328Ritzema J, Troughton R, Melton I, Crozier I, Doughty R, Krum H, Walton A, Adamson P, Kar S, Shah PK, Richards M, Eigler NL, Whiting JS, Haas GJ, Heywood JT, Frampton CM, Abraham WT; Hemodynamically Guided Home Self-Therapy in Severe Heart Failure Patients (HOMEOSTASIS) Study Group. Physician-directed patient self-management of left atrial pressure in advanced chronic heart failure. Circulation. 2010 Mar 9;121(9):1086-95. doi: 10.1161/CIRCULATIONAHA.108.800490. Epub 2010 Feb 22.
PubMed 20176990
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamically Guided Home Self-Therapy in Severe Heart Failure Patients: A Prospective, Multi-center, Non-randomized, Open Label Study.
- ClinicalTrials.gov ID
- NCT00547729
- Acronym / sponsor ID
- HOMEOSTASIS / HP-05-04/HP-12-04
- Conditions
- Heart Failure
- Keywords
- Heart Failure, Left Atrial Pressure Monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Mar 2005
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 23 Oct 2007 (estimated)
- Results
- Posted 6 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a feasibility study of the HeartPOD™ Heart Failure Management System with DynamicRx® (HeartPOD system) in patients with severe chronic congestive heart failure. The device being studied in this trial monitors heart function and alerts the patient and physician of necessary changes to medication. The study will assess the safety, reliability, and preliminary efficacy of the HeartPOD™ system.
Detailed description
Direct cardiac measurements may provide an accurate, reliable and medically acceptable way of informing patients and physicians of worsening CHF prior to the development of symptoms. This may enable physicians to take preventative measures and avoid hospitalization.
This is a feasibility study to assess the safety, reliability, and preliminary efficacy of the HeartPOD™ Heart Failure Management System with DynamicRx®. This feasibility study will be performed in two phases. The first phase will enroll 20 patients at sites in Australia and New Zealand and the second phase will enroll 20 patients at sites in the U.S.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HeartPOD™ System | Experimental | Device: HeartPOD™ SystemImplantation of HeartPOD™ Heart Failure Management System with DynamicRx® |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age > 18 and < 85.
- Documented history of congestive heart failure resulting from ischemic or non-ischemic cardiomyopathy with systolic or diastolic dysfunction of at least 6 months duration.
- Patients with LVEF < 40% should receive maximally tolerated doses of ACE-I (or ARB if ACE-I is not tolerated), beta blockers, and anti-aldosterone therapy. The combination of hydralazine and nitrates should be considered in the persistently symptomatic African American patient.
- A history of NYHA Class II (OUS only), III or IV symptoms.
- Minimum of one (1) prior hospital admission within the last 12 months for exacerbation of CHF or one (1) presentation to the Emergency Department or Clinic requiring parenteral diuretic, vasodilator, inotrope, nesiritide, or equivalent treatment.
Key exclusion criteria (18 listed)
- Intractable HF with resting symptoms despite maximal medical therapy or active listing for cardiac transplantation (< 6 months survival expected).
- Resting systolic blood pressure < 90 or > 180 mmHg.
- Acute MI, unstable ischemic syndrome within the last 6 weeks.
- Percutaneous coronary intervention (PCI) or cardiac surgery performed or planned within 6 weeks.
- Coexisting stenotic valve lesions, vegetations, hypertrophic cardiomyopathy, amyloidosis or other infiltrative heart disease, constrictive, restrictive disease, tamponade, or moderate or large pericardial effusion.
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 |
|---|---|---|
| HeartPOD™ SystemHeartPOD™ device with DynamicRx® automatically measures left heart pressures throughout the day. | Device | HeartPOD™ System |
Primary outcome
Number of Patients Free From Major Adverse Cardiac and Neurological Events (MACNE) at 6 Weeks.
Time frame: 6 Weeks
Out of 71 subjects enrolled, data from 55 subjects was adjudicated by a Clinical Events Committee and included in this primary endpoint analysis. MACNE was defined as a hierarchical composite of cardiovascular related death, myocardial infarction, systemic thromboembolism and stroke.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 18056531Ritzema J, Melton IC, Richards AM, Crozier IG, Frampton C, Doughty RN, Whiting J, Kar S, Eigler N, Krum H, Abraham WT, Troughton RW. Direct left atrial pressure monitoring in ambulatory heart failure patients: initial experience with a new permanent implantable device. Circulation. 2007 Dec 18;116(25):2952-9. doi: 10.1161/CIRCULATIONAHA.107.702191. Epub 2007 Dec 3.
- Derived from this study: PubMed 23448187Pretorius V, Birgersdotter-Green U, Heywood JT, Hafelfinger W, Gutfinger DE, Eigler NL, Love CJ, Abraham WT. An implantable left atrial pressure sensor lead designed for percutaneous extraction using standard techniques. Pacing Clin Electrophysiol. 2013 May;36(5):570-7. doi: 10.1111/pace.12111. Epub 2013 Feb 28.
- Derived from this study: PubMed 21920328Ritzema JL, Richards AM, Crozier IG, Frampton CF, Melton IC, Doughty RN, Stewart JT, Eigler N, Whiting J, Abraham WT, Troughton RW. Serial Doppler echocardiography and tissue Doppler imaging in the detection of elevated directly measured left atrial pressure in ambulant subjects with chronic heart failure. JACC Cardiovasc Imaging. 2011 Sep;4(9):927-34. doi: 10.1016/j.jcmg.2011.07.004.
- Derived from this study: PubMed 20176990Ritzema J, Troughton R, Melton I, Crozier I, Doughty R, Krum H, Walton A, Adamson P, Kar S, Shah PK, Richards M, Eigler NL, Whiting JS, Haas GJ, Heywood JT, Frampton CM, Abraham WT; Hemodynamically Guided Home Self-Therapy in Severe Heart Failure Patients (HOMEOSTASIS) Study Group. Physician-directed patient self-management of left atrial pressure in advanced chronic heart failure. Circulation. 2010 Mar 9;121(9):1086-95. doi: 10.1161/CIRCULATIONAHA.108.800490. Epub 2010 Feb 22.
- Individual participant dataSharing planned: No
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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.
William T. Abraham, MD, FACC study chair
Ohio State University
Henry Krum, MD principal investigator
Monash University/Alfred Hosptial
7 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HeartPOD™ System in people with Heart Failure, run by Abbott Medical Devices at 7 sites in 3 countries.
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 10 inclusion and 18 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 2 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, New Zealand, Australia. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Aug 2021). 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?
Number of Patients Free From Major Adverse Cardiac and Neurological Events (MACNE) at 6 Weeks. (time frame: 6 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00547729, which also lists 4 linked publications.
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 2 Sep 2021.