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


Phase 2
21 Years
N/A
Open (Enrolling)
Both
Heart Failure, Congestive

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Outcome Measure:

peripheral blood flow as assessed by venous occlusion plethysmography

Principal Investigator

Philip A Poole-Wilson, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

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

Authority:

United Kingdom: Medicines Control Agency

Study ID:

02-080

NCT ID:

NCT00285597

Start Date:

May 2004

Completion Date:

January 2006

Related Keywords:

  • Heart Failure, Congestive
  • Heart Failure

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