Working… Menu

Allopurinol in Chronic Heart Failure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00997542
Recruitment Status : Completed
First Posted : October 19, 2009
Last Update Posted : October 19, 2009
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Chronic Heart Failure Hyperuricemia Drug: Allopurinol Drug: Placebo Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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).

Arm Intervention/treatment
Active Comparator: Allopurinol Drug: Allopurinol
Placebo Comparator: Placebo Drug: Placebo

Primary Outcome Measures :
  1. postischemic peak peripheral blood flow

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00997542

Layout table for location information
United Kingdom
Royal Brompton Hospital
London, United Kingdom, SW3 6NP
Sponsors and Collaborators
National Heart and Lung Institute
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00997542    
Other Study ID Numbers: 97-044
First Posted: October 19, 2009    Key Record Dates
Last Update Posted: October 19, 2009
Last Verified: October 2009
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Failure
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Gout Suppressants
Antirheumatic Agents
Free Radical Scavengers
Protective Agents
Physiological Effects of Drugs