Allopurinol in Chronic Heart Failure

October 16, 2009 updated by: National Heart and Lung Institute

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).

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, SW3 6NP
        • Royal Brompton Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Active Comparator: Allopurinol
Drug: Allopurinol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
postischemic peak peripheral blood flow

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Heart and Lung Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

October 16, 2009

First Submitted That Met QC Criteria

October 16, 2009

First Posted (Estimate)

October 19, 2009

Study Record Updates

Last Update Posted (Estimate)

October 19, 2009

Last Update Submitted That Met QC Criteria

October 16, 2009

Last Verified

October 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 97-044

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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