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Ursodeoxycholic Acid in Chronic Heart Failure

Primary Purpose

Heart Failure, Congestive

Status
Unknown status
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
Ursodeoxycholic Acid
Sponsored by
National Heart and Lung Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure, Congestive

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Heart and Lung Institute

Outcomes

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

Full Information

First Posted
January 31, 2006
Last Updated
October 8, 2009
Sponsor
National Heart and Lung Institute
Collaborators
Dr. Falk Pharma GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT00285597
Brief Title
Ursodeoxycholic Acid in Chronic Heart Failure
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2009
Overall Recruitment Status
Unknown status
Study Start Date
May 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Heart and Lung Institute
Collaborators
Dr. Falk Pharma GmbH

4. Oversight

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Congestive

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Ursodeoxycholic Acid
Primary Outcome Measure Information:
Title
peripheral blood flow as assessed by venous occlusion plethysmography
Secondary Outcome Measure Information:
Title
peak and resting arm and leg post-ischaemic blood flow as assessed by venous occlusion plethysmography
Title
tumor Necrosis Factor-alpha (TNF), sCD14, soluble TNF-Receptor 1, Lipopolysaccharide levels
Title
cellular immune function
Title
endothelin-1, B type natriuretic peptide, E-selectin plasma levels

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip A Poole-Wilson, MD
Organizational Affiliation
National Heart and Lung Institute, Dovehouse Street, London SW3 6LY, UK
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Heart and Lung Institute
City
London
ZIP/Postal Code
SW3 6LY
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
22300693
Citation
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.
Results Reference
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Ursodeoxycholic Acid in Chronic Heart Failure

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