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OpenTrials
Completed

NCT Number: NCT00997542

Allopurinol in Chronic Heart Failure

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.

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Key information

Age range

21 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Royal Brompton Hospital

London, SW3 6NP, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Allopurinol

Drug

Placebo

Drug

Primary outcomes

  1. postischemic peak peripheral blood flow

Sponsors and collaborators

Lead sponsor

National Heart and Lung Institute

Other

Registry information

Official study 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).

Important dates

First posted
Oct 19, 2009
Registry last updated
Oct 19, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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