Ursodeoxycholic Acid in Chronic Heart Failure

October 8, 2009 updated by: National Heart and Lung Institute

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

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
peripheral blood flow as assessed by venous occlusion plethysmography

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Heart and Lung Institute

Collaborators

Dr. Falk Pharma GmbH

Investigators

  • Principal Investigator: Philip A Poole-Wilson, MD, National Heart and Lung Institute, Dovehouse Street, London SW3 6LY, UK

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2004

Study Completion

January 1, 2006

Study Registration Dates

First Submitted

January 31, 2006

First Submitted That Met QC Criteria

January 31, 2006

First Posted (Estimate)

February 2, 2006

Study Record Updates

Last Update Posted (Estimate)

October 9, 2009

Last Update Submitted That Met QC Criteria

October 8, 2009

Last Verified

October 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 02-080

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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