Ursodeoxycholic Acid in Chronic Heart Failure

NCT00285597 | Unknown Phase 2

• 1 other identifier: 02-080
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• peripheral blood flow as assessed by venous occlusion plethysmography

Secondary Outcomes (4)

• 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

Interventions

Ursodeoxycholic Acid DRUG

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• National Heart and Lung Institute: lead
• Dr. Falk Pharma GmbH: collaborator

Study Sites (1)

National Heart and Lung Institute

London, SW3 6LY, United Kingdom

Location

Related Publications (1)

• von Haehling S, Schefold JC, Jankowska EA, Springer J, Vazir A, Kalra PR, Sandek A, Fauler G, Stojakovic T, Trauner M, Ponikowski P, Volk HD, Doehner W, Coats AJ, Poole-Wilson PA, Anker SD. Ursodeoxycholic acid in patients with chronic heart failure: a double-blind, randomized, placebo-controlled, crossover trial. J Am Coll Cardiol. 2012 Feb 7;59(6):585-92. doi: 10.1016/j.jacc.2011.10.880.

  PMID: 22300693 DERIVED

MeSH Terms

Conditions

Heart Failure

Interventions

Ursodeoxycholic Acid

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Deoxycholic Acid; Cholic Acids; Bile Acids and Salts; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Cholanes

Study Officials

• Philip A Poole-Wilson, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 31, 2006
• First Posted: February 2, 2006
• Study Start: May 1, 2004
• Study Completion: January 1, 2006
• Last Updated: October 9, 2009

Record last verified: 2009-10

Locations

GB (1)