Allopurinol in Chronic Heart Failure

Chronic Heart Failure Clinical Trial

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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00997542
• Other study ID #: 97-044
• Status: Completed
• Phase: Phase 4
• First received: October 16, 2009
• Last updated: October 16, 2009

Study information

• Verified date: October 2009
• Source: National Heart and Lung Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 21 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Heart Failure
• Heart Failure
• Hyperuricemia

Intervention

Drug:
• Allopurinol

• Placebo

Locations

Country	Name	City	State
United Kingdom	Royal Brompton Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
National Heart and Lung Institute

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postischemic peak peripheral blood flow			Yes