Hemodynamically Guided Home Self-Therapy in Severe Heart Failure Patients (HOMEOSTASIS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT00547729
First received: October 19, 2007
Last updated: August 24, 2012
Last verified: August 2012
  Purpose

Most people with heart failure take a number of medications that work in different ways. Patients and their families need to keep track of prescribed medications and follow instructions on how much to take and when to take them. Currently, doctors are guided primarily by symptoms. The device being studied in this trial (called the HeartPOD™ System) monitors heart function from inside your body and alerts the patient and physician of necessary changes to your medication.


Condition Intervention Phase
Heart Failure
Device: Left Atrial Pressure monitoring
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Hemodynamically Guided Home Self-Therapy in Severe Heart Failure Patients: A Prospective, Multi-center, Non-randomized, Open Label Study.

Resource links provided by NLM:


Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • Freedom from Major Adverse Cardiac and Neurological Events (MACNE) at 6 weeks. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 40
Study Start Date: March 2005
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Implantation of HeartPOD™ System
Device: Left Atrial Pressure monitoring
HeartPOD™ device automatically measures heart pressures throughout the day. This data is collected at follow up visits.
Other Name: HeartPOD™ System

Detailed Description:

The Sponsor believes that direct measurements from your heart may provide an accurate, reliable and medically acceptable way of telling you and your doctor that your CHF is worsening hours to days before the above symptoms would develop and you would notice. This may enable you and your doctor to take preventative measures and avoid hospitalization.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.
  • 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.

Exclusion Criteria:

  • 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.
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00547729

Locations
United States, California
Scripps Green Hospital
La Jolla, California, United States, 92037
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
United States, Ohio
The Ohio State University
Columbus, Ohio, United States, 43210
United States, Oklahoma
Oklahoma Heart Hospital
Oklahoma City, Oklahoma, United States, 73120
Australia, Victoria
Alfred Hospital
Melbourne, Victoria, Australia, 3004
New Zealand
University of Auckland
Auckland, New Zealand
Christchurch Hospital
Christchurch, New Zealand
Sponsors and Collaborators
St. Jude Medical
Investigators
Study Chair: William T. Abraham, MD, FACC Ohio State University
Principal Investigator: Henry Krum, MD Monash University/Alfred Hosptial
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT00547729     History of Changes
Other Study ID Numbers: HP-05-04/HP-12-04
Study First Received: October 19, 2007
Last Updated: August 24, 2012
Health Authority: United States: Food and Drug Administration
Australia: Human Research Ethics Committee

Keywords provided by St. Jude Medical:
Heart Failure
Left Atrial Pressure Monitoring

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 22, 2014