Back to resultsEffects of Allopurinol on Diastolic Function in Chronic Heart Failure Patients
Primary Purpose
Chronic Heart Failure
Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
allopurinol
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Heart Failure focused on measuring chronic heart failure, diastolic dysfunction, uric acid
Eligibility Criteria
Inclusion Criteria:
- chronic heart failure;
- left ventricular systolic dysfunction (ejection fraction <45%)
- stable clinical conditions in the previous three months
- optimal medical therapy for CHF
- normal sinus rhythm
- written informed consent
- age >18 years
Exclusion Criteria:
- renal failure (s-creatinine >2.5 mg/dl)
- already on allopurinol
- malignancies
- chronic inflammatory diseases
Sites / Locations
- Division of Cardiology, University Hospital of Verona
Outcomes
Primary Outcome Measures
diastolic function uric acid levels BNP
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00477789
Brief Title
Effects of Allopurinol on Diastolic Function in Chronic Heart Failure Patients
Official Title
Effects of Allopurinol on Diastolic Function in Chronic Heart Failure Patients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2007
Overall Recruitment Status
Completed
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Name of the Sponsor
Universita di Verona
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
In patients with chronic heart failure (CHF)due to dilated cardiomyopathy diastolic dysfunction occurs frequently and is related to a poor outcome. We have previously shown that parameters of diastolic function significantly correlate with uric acid levels, a marker of impaired oxidative metabolism. We aimed to determine whether inhibition of xanthine oxidase with allopurinol might affect diastolic function in patients with CHF.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Heart Failure
Keywords
chronic heart failure, diastolic dysfunction, uric acid
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
allopurinol
Primary Outcome Measure Information:
Title
diastolic function uric acid levels BNP
Time Frame
three months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
chronic heart failure;
left ventricular systolic dysfunction (ejection fraction <45%)
stable clinical conditions in the previous three months
optimal medical therapy for CHF
normal sinus rhythm
written informed consent
age >18 years
Exclusion Criteria:
renal failure (s-creatinine >2.5 mg/dl)
already on allopurinol
malignancies
chronic inflammatory diseases
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mariantonietta Cicoira, MD, PhD
Organizational Affiliation
Division of Cardiology, University of Verona, Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Division of Cardiology, University Hospital of Verona
City
Verona
ZIP/Postal Code
37129
Country
Italy
12. IPD Sharing Statement
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Effects of Allopurinol on Diastolic Function in Chronic Heart Failure Patients
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