Ursodeoxycholic Acid in Chronic Heart Failure

Heart Failure, Congestive Clinical Trial

Official title:

Ursodeoxycholic Acid Therapy in Chronic Heart Failure: A Placebo-controlled Study Evaluating the Effects of Ursodeoxycholic Acid on Peripheral Blood Flow and Immune Function

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00285597
• Other study ID #: 02-080
• Status: Active, not recruiting
• Phase: Phase 2
• First received: January 31, 2006
• Last updated: October 8, 2009
• Start date: May 2004
• Est. completion date: January 2006

Study information

• Verified date: October 2009
• Source: National Heart and Lung Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines Control AgencyUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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 patients with CHF will be recruited from the heart failure clinic at the Royal Brompton Hospital. Following baseline evaluation, patients will be randomised to receive either placebo or UDCA at a dose of 1000 mg/day for a period of four weeks. They will then undergo repeat evaluation (peripheral blood flow and immune function). A four week washout period will then take place before the patients cross-over to receive the respective other therapy for a further four weeks (i.e. those first receiving placebo will go onto receive UDCA and vice versa). The study will be completed after a total of twelve weeks, with a final assessment (peripheral blood flow and immune function).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 0
• Est. completion date: January 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure, Congestive

Intervention

Drug:
• Ursodeoxycholic Acid

Locations

Country	Name	City	State
United Kingdom	National Heart and Lung Institute	London

Sponsors (2)

Lead Sponsor	Collaborator
National Heart and Lung Institute	Dr. Falk Pharma GmbH

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	peripheral blood flow as assessed by venous occlusion plethysmography
Secondary	peak and resting arm and leg post-ischaemic blood flow as assessed by venous occlusion plethysmography
Secondary	tumor Necrosis Factor-alpha (TNF), sCD14, soluble TNF-Receptor 1, Lipopolysaccharide levels
Secondary	cellular immune function
Secondary	endothelin-1, B type natriuretic peptide, E-selectin plasma levels