Allopurinol in Chronic Heart Failure

NCT00997542 | Completed Phase 4

• 1 other identifier: 97-044
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Heart Failure; Hyperuricemia

Outcome Measures

Primary Outcomes (1)

• postischemic peak peripheral blood flow

Study Arms (2)

Allopurinol

ACTIVE COMPARATOR

Drug: Allopurinol

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Allopurinol DRUG

Allopurinol

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 21 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 .

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Heart and Lung Institute: lead

Study Sites (1)

Royal Brompton Hospital

London, SW3 6NP, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 21849262 DERIVED

MeSH Terms

Conditions

Hyperuricemia

Interventions

Allopurinol

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 16, 2009
• First Posted: October 19, 2009
• Last Updated: October 19, 2009

Record last verified: 2009-10

Locations

GB (1)