Clinical trial NCT00997542: Allopurinol in Chronic Heart Failure
Official title: A Double-blind, Placebo-controlled, Cross-over Study of the Effects of Allopurinol on Oxidative Metabolism, Peripheral Blood Flow and Immune Function in Patients With Advanced Chronic Heart Failure (CHF).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Heart Failure
Hyperuricemia
Lead sponsor: National Heart and Lung Institute
Sponsor class: OTHER
First posted: 2009-10-19
Enrollment: 16
Sex: MALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to discover whether the inhibition of the xanthine oxidase with allopurinol leads to a reduction of the production of oxygen free radicals in patients with CHF and thereby improves characteristics of oxydative metabolism, peripheral blood flow, immune function and functional status.


Eligibility criteria: Inclusion Criteria:

* The patient is a male and at least 21 years of age.
* The patient has clinical evidence of heart failure: a) reduced ejection fraction (≤40%) or cardiomegaly on CXR or left ventricular impairment on echocardiography (LVEDD ≥60mm), b) stable clinical condition and medication for at least 1 month prior to the study.
* No history of unstable angina, myocardial infarction or stroke within 3 months prior to the study.
* The patient is receiving full conventional medical therapy for heart failure (ACE inhibitor or angiotensin II blocker, diuretics etc.).
* The patient is willing and capable of complying with the requirements of this protocol.
* The patient has provided written informed consent .

Exclusion Criteria:

* The patient has any life-threatening disease, other than heart failure (including patients with known, or suspected, myocarditis or with automatic implantable cardioverter/defibrillators).
* The patient has an active malignancy of any type, or history of a malignancy (Patients who have a history of basal cell carcinoma that has been surgically removed are acceptable). 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 also acceptable.
* The patient has had a heart transplant.
* The patient has severe renal disease (S-Creatinine \>300 μmol/l), severe liver disease (ASAT or ALAT \> 3 times of upper limit of normal range), rheumatoid arthritis, or complains of gout.
* The patients has received allopurinol therapy previously or if he is known to suffer from gout (acutely or chronically).
* The patient has an exercise capacity of \> 20 ml/kg/min (treadmill, Bruce protocol) or is in functional NYHA class I.

Primary outcomes:
measure: postischemic peak peripheral blood flow
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Royal Brompton Hospital
Study officials:
References:
citation: Fravel MA, Ernst ME. Management of gout in the older adult. Am J Geriatr Pharmacother. 2011 Oct;9(5):271-85. doi: 10.1016/j.amjopharm.2011.07.004. Epub 2011 Aug 17.