Clinical trial NCT00399919: Safety and Efficacy of Propionyl-L-Carnitine in the Treatment of Peripheral Arterial Disease (Intermittent Claudication)
Official title: Safety and Efficacy pf Propionyl-L-Carnitine in Combination With Monitored Exercise Training in Peripheral Arterial Disease (Intermittent Claudication).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Peripheral Vascular Diseases
Intermittent Claudication
Keywords: Perhipheral Artery Disease
Claudication
Exercise
Intermittent Claudication due to Peripheral Artery Disease
Lead sponsor: Sigma-Tau Research, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Colorado Prevention Center
First posted: 2006-11-15
Enrollment: 69
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients with peripheral artery disease have decreased blood flow to exercising muscle causing pain. This decreased blood flow to the muscle affects the level of acylcarnitines which in turn decreases the level of carnitine. Carnitine allows muscles to function properly. This study will test the safety and efficacy of Propionyl-L-Carnitine taken in combination with a monitored exercise training program.

Detailed description: To test the hypothesis that Propionyl-L-Carnitine taken in combination with monitored exercise training may improve exercise performance the study will randomize male or female adults with peripheral artery disease and claudication to receive either Proprionyl-L-Carnitine or Placebo.

Eligibility criteria: Inclusion Criteria:

* Ambulatory outpatient who are able to exercise
* Intermittent claudication due to peripheral artery disease
* Willingness to participate in a monitored exercise training program

Exclusion Criteria:

* Pain at rest, ischemic ulcerations, gangrene of the lower extremity
* Peripheral Artery Disease of a non-atherosclerotic nature
* Any disease process other than PAD, that may interfere with performance during the treadmill test or prevent the subject from reaching their claudication-limited PWT
* Current participation in an exercise training program or previous participtation in a monitored exercise training program within 6 months of the screening visit.

Primary outcomes:
measure: Peak walking time
timeFrame: 6 months
Secondary outcomes:
measure: Claudication onset time, activity level and quality of life
timeFrame: 6 months
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Jacksonville Center for Clinical Research
state: Florida
city: Pensacola
country: United States
facility: Baptist Clinical Research
state: Florida
city: LaGrange
country: United States
facility: Western Suburban Cardiologists, Ltd.
state: Illinois
city: Springfield
country: United States
facility: SIU School of Medicine
state: Illinois
city: Worchester
country: United States
facility: University of Massachusetts Medical Center
state: Massachusetts
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Asheville
country: United States
facility: Asheville Cardiology Associates
state: North Carolina
city: Durham
country: United States
facility: Durham VA Medical Center
state: North Carolina
Study officials:
affiliation: Western Suburban Cardiologists, Ltd.
name: Edgar Carell
role: PRINCIPAL_INVESTIGATOR
affiliation: Durham VA Medical Center
name: Kenneth Morris
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Massachusetts, Worcester
name: Bruce Cutler
role: PRINCIPAL_INVESTIGATOR
affiliation: SIU School of Medicine
name: Robert McLafferty
role: PRINCIPAL_INVESTIGATOR
affiliation: Dartmouth-Hitchcock Medical Center
name: Richard Powell
role: PRINCIPAL_INVESTIGATOR
affiliation: Baptist Clinical Research
name: Layne Yonehiro
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Rochester
name: Karl Illig
role: PRINCIPAL_INVESTIGATOR
affiliation: Asheville Cardiology Associates
name: William Abernethy
role: PRINCIPAL_INVESTIGATOR
affiliation: Jacksonville Center For Clinical Research
name: Michael Koren
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mays RJ, Wesselman CW, White R, Creager MA, Amato A, Greenwalt M, Hiatt WR. Automated Detection of Exercise Sessions in Patients With Peripheral Artery Disease: EVIDENCE FOR AN EXERCISE DOSE RESPONSE TO TRAINING. J Cardiopulm Rehabil Prev. 2021 May 1;41(3):176-181. doi: 10.1097/HCR.0000000000000553.
citation: Hiatt WR, Creager MA, Amato A, Brass EP. Effect of propionyl-L-carnitine on a background of monitored exercise in patients with claudication secondary to peripheral artery disease. J Cardiopulm Rehabil Prev. 2011 Mar-Apr;31(2):125-32. doi: 10.1097/HCR.0b013e3181f1fd65.