Clinical trial NCT01738542: Safety and Efficacy Study of Bosentan for Intermittent Claudication in Peripheral Arterial Disease
Official title: CLAU Test Results (CLinical Assessment And Endothelin fUnction Assessment After Endothelin Receptor Antagonist) : Randomized Controlled Clinical Trial of Bosentan for Intermittent Claudication in Peripheral Arterial Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Arterial Disease
Keywords: Bosentan
Peripheral Arterial Disease
Lead sponsor: Hospital Universitario Getafe
Sponsor class: OTHER
First posted: 2012-11-30
Enrollment: 30
Sex: MALE
Minimum age (years): 50
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A prospective study, proof-of concept, randomized, controlled, parallel groups, simple blind was performed in 30 male patients (50-60 years old) with Intermittent Claudication (Rutherford category 1-2) recently diagnosed and clinical manifestations not exceeding 6 months with hypertension and/or dyslipidemia as unique co-morbility disorders. After a period of stabilization of the claudication distance in the Stress test (12.5%, 3.2 km/h) during 2 weeks, were randomized 1:1 to the experimental arm (Bosentan 62.5 mg twice daily/four weeks and 125 mg twice daily/eight weeks) or control group.


Eligibility criteria: Inclusion Criteria:

* Arterial hypertension and hypercholesterolemia
* ABI \<0,9
* Positive claudiometry with a claudication distance between 50 and 500

Exclusion Criteria:

* surgical patient
* Previous revascularization procedure in the Member studied
* Smoker
* Uncontrolled hypertension
* Cardiac Stress Test unfinished
* Prior DVT
* Concomitant severe disease
* Obesity

Primary outcomes:
measure: Change in Absolute Claudication Distance (ACD) respect baseline values
timeFrame: 1 Year
measure: Change in flow-mediated arterial dilation (FMAD) respect baseline values
timeFrame: 1 Year
Secondary outcomes:
measure: Changes in Analytical plasma values at each visit respect baseline values
timeFrame: 1 Year
measure: Change in the ankle brachial index (ABI) respect baseline values
timeFrame: 1 Year
measure: Change in subjective claudication distance (SCD) reported by the patient, as is defined in the Walking Impairment Questionnaire (WIQ), respect baseline values
timeFrame: 1 Year
measure: Occurrence of Adverse events during the study
timeFrame: 1 Year
Other outcomes:
measure: Change in the serum levels of Endothelin (ET) respect baseline values
timeFrame: 1 Year
measure: Change in the serum levels of C-reactive protein (CRP) respect baseline values
timeFrame: 1 Year
Locations:
city: Getafe
country: Spain
facility: Hospital Universitario de Getafe
state: Madrid
Study officials:
affiliation: Hospital Universitario de Getafe
name: De Haro Joaquin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: De Haro J, Bleda S, Varela C, Esparza L, Acin F; Bosentan Population-Based Randomized Trial for Clinical and Endothelial Function Assessment on Endothelin Antagonist Therapy in Patients With Intermittent Claudication CLAU Investigators. Effect of Bosentan on Claudication Distance and Endothelium-Dependent Vasodilation in Hispanic Patients With Peripheral Arterial Disease. Am J Cardiol. 2016 Jan 15;117(2):295-301. doi: 10.1016/j.amjcard.2015.10.032. Epub 2015 Nov 6.