Allopurinol in Chronic Heart Failure

Phase 4

Completed

• Conditions: Chronic Heart Failure; Hyperuricemia
• Interventions: Drug: Placebo; Drug: Allopurinol

• Registration Number: NCT00997542
• Lead Sponsor: National Heart and Lung Institute

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2009-10
• Study First Submitted: 2009-10-16
• Study First Submitted QC: 2009-10-16
• Last Update Submitted: 2009-10-16
• Study First Posted: 2009-10-19
• Last Update Posted: 2009-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 16

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 .

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Allopurinol	Allopurinol	-

Primary Outcome Measures

Name	Time	Method
postischemic peak peripheral blood flow

Trial Locations

Locations (1)

Royal Brompton Hospital; 🇬🇧 London, United Kingdom