L-Arginine Supplementation and Exercise; L-Arginine Supplementation and Renal Function

This study has been completed.

Sponsor:

Information provided by:

University Hospital, Strasbourg, France

ClinicalTrials.gov Identifier:

NCT00213915

First received: September 13, 2005

Last updated: November 28, 2007

Last verified: November 2007

History of Changes

Tracking Information

First Received Date ^ICMJE

September 13, 2005

Last Updated Date

November 28, 2007

Start Date ^ICMJE

February 2004

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Maximal and sub maximal exercise capacity at the end of the 6 weeks L-arginine supplementation. Renal function at the end of the 6 weeks

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00213915 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

No secondary effects

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

L-Arginine Supplementation and Exercise; L-Arginine Supplementation and Renal Function

Official Title ^ICMJE

Effects of Oral Chronic L-Arginine Supplementation on Exercise and Renal Function of Heart Transplant Recipients

Brief Summary

exercise capacities are still altered after heart transplantation partly due to peripheral endothelial dysfunction
cyclosporin-induced renal dysfunction may be due to renal endothelial dysfunction and can be reversed in an animal model by L-arginine supplementation
to determine the potential beneficial effect of L-arginine supplementation on exercise capacity and renal function of heart transplant recipients

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Condition ^ICMJE

Heart Transplantation

Intervention ^ICMJE

Drug: 12 g of L-arginine glutamate during 6 weeks twice a day

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 2004

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Male (> 18 years old) stable heart transplant recipient for at least 6 weeks
Stable treatment for at least 3 months
Sedentary people

Exclusion Criteria:

Unstable cardiac pathology
Obesity (IMC > 40)
Participation in another study in the last month
Chronic renal failure (creatinine clearance < 20 ml/min)
Renal transplantation
Diabetes
Impossibility to practice exercise test
Nitrate therapy

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT00213915

Other Study ID Numbers ^ICMJE

3031

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

University Hospital, Strasbourg, France

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Stephane DOUTRELEAU, MD

Service de Physiologie et d'Explorations Fonctionnelles

Information Provided By

University Hospital, Strasbourg, France

Verification Date

November 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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