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

Heart Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00213915
• Other study ID #: 3031
• Status: Completed
• Phase: Phase 4
• First received: September 13, 2005
• Last updated: November 28, 2007
• Start date: February 2004
• Est. completion date: December 2004

Study information

• Verified date: November 2007
• Source: University Hospital, Strasbourg, France
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Heart Transplantation

Intervention

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

Locations

Country	Name	City	State
France	Institut de Physiologie	Strasbourg
France	Service de Chirurgie Vasculaire	Strasbourg
France	Service des Explorations Fonctionnelles Respiratoires et de l'Exercice	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	No secondary effects