Randomized Trial for Patients With Chronic Heart Failure With Acute Decompensation

NCT00357591 | Terminated DMC

• 1 other identifier: IDEG020301
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Heart Failure, Congestive

Keywords

Heart Failure; Acute Decompensation; Chronic Heart Failure

Outcome Measures

Primary Outcomes (1)

• Alive, Number of days out of the hospital, not on mechanical assistance over 35 day period.

  35 days

Study Arms (1)

Control

ACTIVE COMPARATOR

Device: Continuous Aortic Flow Augmentation

Interventions

Continuous Aortic Flow Augmentation DEVICE

1.0-1.5 lpm augmented blood flow

Control

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients hospitalized due to decompensated heart failure who require IV inotropic and/or vasodilator and diuretic therapy
• 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
• 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
• LVEF \< 35%
• Male or female 18-90 years of age
• If female, no child-bearing potential or negative pregnancy test
• Written informed consent
• Willingness to participate in required follow-up exams

You may not qualify if:

• Acute Q-wave myocardial infarction within past 7 days
• Post cardiotomy shock within past 30 days
• Cardiac surgery within past 14 days
• Bridge to transplant
• History of severe COPD as defined as FEV1 \< 1.0 liter
• 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
• Patients implanted with a resynchronization device within the previous 14 days or if there is a possibility of implant within 60 days following randomization
• Systolic pressure \<80 mmHg
• Requiring cardiopulmonary support type devices
• Platelets \< 50,000/mm3 or other evidence of coagulopathy, INR greater than 1.5 in the absence of anticoagulation therapy.
• Infection (WBC ≥ 12.5 x 103/ml, and or temperature ≥ 100.5°F/38°C)
• History of cerebral vascular accident (CVA) or transient ischemic attacks (TIA) within the last 3 months
• Unwilling or unable to receive blood transfusion

Sponsors & Collaborators

• Orqis Medical Corporation: lead

Study Sites (1)

University of California at San Diego

San Diego, California, 92103, United States

Location

Related Publications (2)

• Zile MR, Colombo PC, Mehra M, Greenberg B, Brown S, Konstam MA. Progressive improvement in cardiac performance with continuous aortic flow augmentation (aortic flow therapy) in patients hospitalized with severe heart failure: results of the Multicenter Trial of the Orqis Medical Cancion System for the Enhanced Treatment of Heart Failure Unresponsive to Medical Therapy (MOMENTUM). J Heart Lung Transplant. 2010 Jan;29(1):86-92. doi: 10.1016/j.healun.2009.10.005.

  PMID: 20123246 DERIVED

• Greenberg B, Czerska B, Delgado RM, Bourge R, Zile MR, Silver M, Klapholz M, Haeusslein E, Mehra MR, Mather P, Abraham WT, Neaton JD, Brown BS, Parker IC, Konstam MA; MOMENTUM Investigators and Coordinators. Effects of continuous aortic flow augmentation in patients with exacerbation of heart failure inadequately responsive to medical therapy: results of the Multicenter Trial of the Orqis Medical Cancion System for the Enhanced Treatment of Heart Failure Unresponsive to Medical Therapy (MOMENTUM). Circulation. 2008 Sep 16;118(12):1241-9. doi: 10.1161/CIRCULATIONAHA.108.773275. Epub 2008 Sep 2.

  PMID: 18765394 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Barry H Greenberg, M.D.

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 25, 2006
• First Posted: July 27, 2006
• Study Start: September 1, 2004
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: December 25, 2009

Record last verified: 2009-08

Locations

US (1)