Status:
UNKNOWN
Ursodeoxycholic Acid in Chronic Heart Failure
Lead Sponsor:
National Heart and Lung Institute
Collaborating Sponsors:
Dr. Falk Pharma GmbH
Conditions:
Heart Failure, Congestive
Eligibility:
All Genders
21+ years
Phase:
PHASE2
Brief Summary
This is a double-blind, placebo-controlled, cross-over study evaluating the effects of UDCA on peripheral blood flow and immune function in patients with stable chronic heart failure (CHF). Sixteen pa...
Eligibility Criteria
Inclusion
- age \>21 years
- of either sex
- the patient is willing and capable of complying with the requirements of this protocol
- the patient has provided written informed consent
- the patient has clinical evidence of chronic heart failure:
- reduced ejection fraction (≤40%) or left ventricular impairment on echocardiography (LVEDD ≥60mm)
- stable clinical condition and medication for at least 1 month prior to the study (New York Heart Association class II-IV).
- the patient is receiving appropriate conventional medical therapy for heart failure (ACE inhibitor or angiotensin II blocker, diuretics, beta-blocker as indicated and tolerated).
Exclusion
- congenital heart disease
- any life-threatening disease, other than heart failure
- active malignancy of any type, or history of a malignancy within previous 5 years. Patients with a history of other malignancies that have been surgically removed and who have no evidence of recurrence for at least five years prior to study enrolment are acceptable.
- previous heart transplant
- severe neuro-muscular disease
- history of unstable angina, myocardial infarction or stroke within 3 months prior to the study
- pregnancy or women of child-bearing age
- treatment with immunosuppressive therapy e.g. steroids for rheumatoid arthritis or obstructive lung disease
- significant renal dysfunction (serum creatinine \>250mmol/l), severe liver disease (liver function tests \> 3 times normal)
- unable to understand and comply with protocol or to give informed consent
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
End Date :
January 1 2006
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00285597
Start Date
May 1 2004
End Date
January 1 2006
Last Update
October 9 2009
Active Locations (1)
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1
National Heart and Lung Institute
London, United Kingdom, SW3 6LY