Ursodeoxycholic Acid in Chronic Heart Failure

The recruitment status of this study is unknown because the information has not been verified recently.

Verified October 2009 by National Heart and Lung Institute. Recruitment status was Active, not recruiting

First Received on January 31, 2006. Last Updated on October 8, 2009 History of Changes

Sponsor:	National Heart and Lung Institute
Collaborator:	Dr. Falk Pharma GmbH
Information provided by:	National Heart and Lung Institute
ClinicalTrials.gov Identifier:	NCT00285597

Purpose

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).

Condition	Intervention	Phase
Heart Failure, Congestive	Drug: Ursodeoxycholic Acid	Phase II

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

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure

Drug Information available for: Ursodeoxycholic acid

U.S. FDA Resources

Further study details as provided by National Heart and Lung Institute:

Primary Outcome Measures:

peripheral blood flow as assessed by venous occlusion plethysmography

Secondary Outcome Measures:

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

Study Start Date:	May 2004
Estimated Study Completion Date:	January 2006

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00285597

Locations

United Kingdom
National Heart and Lung Institute
London, United Kingdom, SW3 6LY

Sponsors and Collaborators

National Heart and Lung Institute

Dr. Falk Pharma GmbH

Investigators

Principal Investigator:

Philip A Poole-Wilson, MD

National Heart and Lung Institute, Dovehouse Street, London SW3 6LY, UK

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00285597 History of Changes
Other Study ID Numbers:	02-080
Study First Received:	January 31, 2006
Last Updated:	October 8, 2009
Health Authority:	United Kingdom: Medicines Control Agency; United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:

Heart Failure
Heart Diseases
Cardiovascular Diseases
Ursodeoxycholic Acid

Cholagogues and Choleretics
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012