Allopurinol in Chronic Heart Failure

This study has been completed.
Sponsor:
Information provided by:
National Heart and Lung Institute
ClinicalTrials.gov Identifier:
NCT00997542
First received: October 16, 2009
Last updated: NA
Last verified: October 2009
History: No changes posted
  Purpose

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 Intervention Phase
Chronic Heart Failure
Hyperuricemia
Drug: Allopurinol
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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).

Resource links provided by NLM:


Further study details as provided by National Heart and Lung Institute:

Primary Outcome Measures:
  • postischemic peak peripheral blood flow [ Designated as safety issue: Yes ]

Enrollment: 16
Arms Assigned Interventions
Active Comparator: Allopurinol Drug: Allopurinol
Placebo Comparator: Placebo Drug: Placebo

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00997542

Locations
United Kingdom
Royal Brompton Hospital
London, United Kingdom, SW3 6NP
Sponsors and Collaborators
National Heart and Lung Institute
  More Information

No publications provided by National Heart and Lung Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00997542     History of Changes
Other Study ID Numbers: 97-044
Study First Received: October 16, 2009
Last Updated: October 16, 2009
Health Authority: United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Heart Failure
Hyperuricemia
Cardiovascular Diseases
Heart Diseases
Pathologic Processes
Allopurinol
Antimetabolites
Antioxidants
Antirheumatic Agents
Enzyme Inhibitors
Free Radical Scavengers
Gout Suppressants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014