Protective Effects of L-arginine During Reperfusion by Femoropopliteal Bypass for Lower Limb Ischemic Syndrome in Humans

NCT02117206 | Completed Phase 4

• 1 other identifier: 3262
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The symptoms and severity of arterial disease is secondary to perfusion deficit. The specific alteration of the mitochondrial function of ischemic skeletal muscle plays an important role, and therapeutic enhancing mitochondrial function are associated with a clinical improvement with increase in the walking distance of the patient. In severe ischemia, reperfusion required is accompanied by a deleterious episode through a worsening of endothelial dysfunction (impaired pathway of nitric oxide (NO)), majorant alteration of cellular energy and the hormonal and inflammatory responses. This is reperfusion syndrome, which can lead to grave consequences. Our goal is to limit mitochondrial and endothelial dysfunction (increased by the reperfusion) by stimulating the NO pathway by in situ addition of its precursor, L-arginine. Our working hypothesis is that this cellular improvement will be accompanied by an increase in systolic pressure index and an improvement in the walking distance. Method: This is a trial with direct individual benefit, comparative, randomized, prospective, single-center, double-blind, versus placebo.

Conditions

Skeletal Muscle Ischemia; Severe Lower Limb Ischemia; Mitochondrial Dysfunction

Keywords

L-arginine

Outcome Measures

Primary Outcomes (1)

• Protective effect of L-Arginine on skeletal muscle: V0 and Vmax measurements ACR (Acceptor control ratio)=Vmax/V0

  Immediate post surgery muscle biopsy analysis

Secondary Outcomes (1)

• Increase walking distance and ankle brachial index

  1 month and 3 months after surgery

Study Arms (2)

L-Arginine

ACTIVE COMPARATOR

Femoral arterial infusion of 2 g L-Arginine for 30 min

Drug: L-arginine (L-arginine Veyron)

Nacl

PLACEBO COMPARATOR

Femoral arterial infusion of Nacl for 30 min

Drug: Nacl

Interventions

L-arginine (L-arginine Veyron) DRUG

L-Arginine

Nacl DRUG

Nacl

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• atherosclerotic patient with peripheral arterial disease stage 2-4 Leriche and Fontaine classification
• requiring surgical revascularization by femoropopliteal bypass
• above 18 years old

You may not qualify if:

• active infectious disease
• severe heart disease
• chronic renal insufficency
• pregnant women
• women of childbearing age and with no effective contraception for at least three months

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

SERVICE DE PHYSIOLOGIE ET D'EXPLORATIONS FONCTIONNELLES- Nouvel Hôpital Civil, HUS

Strasbourg, 67091, France

Location

MeSH Terms

Conditions

Mitochondrial Diseases

Interventions

Arginine; Sodium Chloride

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino; Amino Acids, Essential; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Fabien THAVEAU, MD

  Hôpitaux Universitaires de Strasbourg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2014
• First Posted: April 17, 2014
• Study Start: November 1, 2005
• Primary Completion: March 1, 2012
• Study Completion: November 1, 2013
• Last Updated: April 17, 2014

Record last verified: 2014-04

Locations

FR (1)