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Ursodeoxycholic Acid in Chronic Heart Failure

NCT00285597 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2009-10-09

No results posted yet for this study

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).

Conditions

  • Heart Failure, Congestive

Interventions

DRUG

Ursodeoxycholic Acid

Sponsors & Collaborators

  • Dr. Falk Pharma GmbH

    collaborator INDUSTRY

  • National Heart and Lung Institute

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-05-31
Completion
2006-01-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00285597 on ClinicalTrials.gov