Allopurinol in Chronic Heart Failure

NCT ID: NCT00997542

Last Updated: 2009-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Brief Summary

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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

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Conditions

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Chronic Heart Failure Hyperuricemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Allopurinol

Group Type ACTIVE_COMPARATOR

Allopurinol

Intervention Type DRUG

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Allopurinol

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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National Heart and Lung Institute

OTHER

Sponsor Role lead

Locations

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Royal Brompton Hospital

London, , United Kingdom

Site Status

Countries

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United Kingdom

References

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Fravel MA, Ernst ME. Management of gout in the older adult. Am J Geriatr Pharmacother. 2011 Oct;9(5):271-85. doi: 10.1016/j.amjopharm.2011.07.004. Epub 2011 Aug 17.

Reference Type DERIVED
PMID: 21849262 (View on PubMed)

Other Identifiers

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97-044

Identifier Type: -

Identifier Source: org_study_id

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