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Ursodeoxycholic Acid in Chronic Heart Failure

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2009 by National Heart and Lung Institute.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00285597
First Posted: February 2, 2006
Last Update Posted: October 9, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Dr. Falk Pharma GmbH
Information provided by:
National Heart and Lung Institute
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
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:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00285597     History of Changes
Other Study ID Numbers: 02-080
First Submitted: January 31, 2006
First Posted: February 2, 2006
Last Update Posted: October 9, 2009
Last Verified: October 2009

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Ursodeoxycholic Acid
Cholagogues and Choleretics
Gastrointestinal Agents