Effects of Allopurinol on Diastolic Function in Chronic H... | NCT00477789

Studies
Effects of Allopurinol on Diastolic Function in Chronic Heart Failure Patients

NCT00477789

Sponsor

Universita di Verona

Status

Completed

Last Update Posted

May 24, 2007Estimated

Enrollment

Not provided

Phase

Phase 4

Conditions

Chronic Heart Failure

Interventions

allopurinol

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

May 23, 2007

First Submission Date that Met QC Criteria

May 23, 2007

First Posted Date

May 24, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 23, 2007

Last Update Posted Date

May 24, 2007Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
allopurinol	Drug

Measure	Description	Time Frame
diastolic function uric acid levels BNP		three months

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mariantonietta Cicoira, MD, PhD	Division of Cardiology, University of Verona, Italy	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Division of Cardiology, University Hospital of Verona		Verona		37129	Italy

Intervention Browse Module

MeSH Terms

ID	Term
D000493	Allopurinol

Ancestor Terms

ID	Term
D011687	Purines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds

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Browse Branches

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