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