Randomized Trial for Patients With Chronic Heart Failure With Acute Decompensation

This study has been terminated.
(Projected neutral significance for primary composite efficacy endpoint.)
Sponsor:
Information provided by:
Orqis Medical Corporation
ClinicalTrials.gov Identifier:
NCT00357591
First received: July 25, 2006
Last updated: December 24, 2009
Last verified: August 2009
  Purpose

The Company's proprietary products are based on Orqis Medical's hypothesis, supported by early clinical data, that increasing and maintaining continuous blood flow in the descending aorta, known as continuous aortic flow augmentation or CAFA, improves hemodynamics in heart failure patients. The clinical impact of the hemodynamic improvement is currently being evaluated to determine the effects of CAFA on stopping or reversing the progression of heart failure through three physiological effects:

  • VASCULAR - Reducing systemic vascular resistance
  • RENAL - Improving renal function
  • CARDIAC - Reducing cardiac workload

Condition Intervention
Heart Failure, Congestive
Device: Continuous Aortic Flow Augmentation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: MOMENTUM: Multicenter Trial of the Orqis Medical CRS for the Enhanced Treatment of CHF Unresponsive to Medical Therapy

Resource links provided by NLM:


Further study details as provided by Orqis Medical Corporation:

Primary Outcome Measures:
  • Alive, Number of days out of the hospital, not on mechanical assistance over 35 day period. [ Time Frame: 35 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: September 2004
Study Completion Date: January 2008
Estimated Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Control Device: Continuous Aortic Flow Augmentation
1.0-1.5 lpm augmented blood flow

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients hospitalized due to decompensated heart failure who require IV inotropic and/or vasodilator and diuretic therapy
  2. Patients receiving appropriate medical therapy for heart failure, defined as ACE inhibitors and beta blockers (all unless not tolerated or contraindicated) and diuretics, for 1 month prior to study entry
  3. For at least 24 hours prior to inclusion into the study, the patient should be treated with a minimum dose of the following: dobutamine 2.5μg/kg/min or milrinone 0.3μg/kg/min or dopamine 5μg/kg/min. or nesiritide 0.01μg/kg/min or nitroglycerin 0.3 µg/kg/min or nitroprusside 0.3 µg/kg/min or a combination of any of these agents, with diuretic therapy. Doses of the above stated medications should be stable for 6 hours prior to inclusion into study. An increase in this dosage within the first 8 hours after enrollment is determined by the attending physician to be unlikely and the following definition of "not responding adequately to IV inotropic and/or vasodilator and diuretic therapy" is exhibited:

    • PCWP is ≥ 20 mmHg at time of randomization and PCWP was ≥ 18 mmHg continuously for 24 hours or PCWP ≥ 20 mmHg continuously for 12 hours prior to randomization.
    • Cardiac Index < 2.4 L/min/m2
    • There is evidence for abnormal renal function and/or diuretic resistance defined as: Serum creatinine > 1.2 mg/dL or Diuretic dosage of intravenous Furosemide ≥ 120 mg daily, or equivalent
  4. LVEF < 35%
  5. Male or female 18-90 years of age
  6. If female, no child-bearing potential or negative pregnancy test
  7. Written informed consent
  8. Willingness to participate in required follow-up exams

Exclusion Criteria:

  1. Acute Q-wave myocardial infarction within past 7 days
  2. Post cardiotomy shock within past 30 days
  3. Cardiac surgery within past 14 days
  4. Bridge to transplant
  5. History of severe COPD as defined as FEV1 < 1.0 liter
  6. History of malignant arrhythmias defined as either:

    • sustained ventricular tachycardia > 15 beats or more in length, not associated with a correctable cause, within the preceding 3 months, unless the patient presently has an implantable cardiac defibrillator.
    • history of ventricular fibrillation or sudden death, unless the patient presently has an implantable cardiac defibrillator
  7. Patients implanted with a resynchronization device within the previous 14 days or if there is a possibility of implant within 60 days following randomization
  8. Systolic pressure <80 mmHg
  9. Requiring cardiopulmonary support type devices
  10. Platelets < 50,000/mm3 or other evidence of coagulopathy, INR greater than 1.5 in the absence of anticoagulation therapy.
  11. Infection (WBC ≥ 12.5 x 103/ml, and or temperature ≥ 100.5°F/38°C)
  12. History of cerebral vascular accident (CVA) or transient ischemic attacks (TIA) within the last 3 months
  13. Unwilling or unable to receive blood transfusion
  14. Inability to undergo treatment with heparin
  15. Patients on dialysis or serum creatinine > 4.0 mg/dl
  16. Primary liver disease with bilirubin, SGOT, or SGPT > 4X upper limit of normal
  17. Life expectancy from other disease < 12 months
  18. Patients who are active on the cardiac transplantation waiting list, unless there is a documented reason (large body habitus, highly sensitized, O blood group) to anticipate that transplant is unlikely within the subsequent 65 days.
  19. Symptomatic patent foramen ovale or intracardiac shunt
  20. Patients diagnosed with clinically significant peripheral vascular disease, defined as absent pedal pulse or signs or symptoms of limb ischemia, including a history of intermittent claudication
  21. Patients with amyloidosis, thyroid induced heart failure, high output failure secondary to an arterio-venous fistula, and significant uncorrected primary valvular disease (with the exception of mitral regurgitation believed secondary to LV dilatation)
  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: NCT00357591

Locations
United States, California
University of California at San Diego
San Diego, California, United States, 92103
Sponsors and Collaborators
Orqis Medical Corporation
Investigators
Principal Investigator: Barry H Greenberg, M.D. University of California, San Diego
  More Information

Additional Information:
No publications provided by Orqis Medical Corporation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Irene Parker/VP Regulatory Affairs, Orqis Medical Corporation
ClinicalTrials.gov Identifier: NCT00357591     History of Changes
Other Study ID Numbers: IDEG020301
Study First Received: July 25, 2006
Last Updated: December 24, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Orqis Medical Corporation:
Heart Failure
Acute Decompensation
Chronic Heart Failure

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on October 29, 2014