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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
30
Bosentan 62.5 mg/12 hours (first four weeks) and 125 mg/12 hours (eight weeks)
AAS 100mg/d or Clopidogrel 75mg/d
Hospital Universitario de Getafe
Getafe, Madrid, Spain
Change in Absolute Claudication Distance (ACD) respect baseline values
To determine the efficacy of bosentan on the improvement in the absolute claudication distance in the exercise in patients with Intermittent Claudication due Peripheral Arterial Disease. ACD and percentage of change, both for the treatment group and control group, at each visit after baseline : 1 month, 3 months, 6 months and 12 months
Time frame: 1 Year
Change in flow-mediated arterial dilation (FMAD) respect baseline values
To determine the efficacy of bosentan on the improvement in the overall endothelin function in patients with Intermittent Claudication due Peripheral Arterial Disease FMAD for the treatment group and control group, at each visit after baseline : 1 month, 3 months, 6 months and 12 months
Time frame: 1 Year
Changes in Analytical plasma values at each visit respect baseline values
Safety of Bosentan in patients with Intermittent Claudication due Peripheral Arterial Disease. Analytical values : plasma electrolyte values, hepatic function, renal function, coagulation profiles, peripheral blood cell count
Time frame: 1 Year
Change in the ankle brachial index (ABI) respect baseline values
Efficacy of bosentan on the improvement in the hemodynamic states in patients with Intermittent Claudication due Peripheral Arterial Disease. ABI for the treatment group and control group, at each visit after baseline : 1 month, 3 months, 6 months and 12 months
Time frame: 1 Year
Change in subjective claudication distance (SCD) reported by the patient, as is defined in the Walking Impairment Questionnaire (WIQ), respect baseline values
Efficacy of bosentan on the improvement of functional status (symptoms of claudication) in patients with Intermittent Claudication due Peripheral Arterial Disease SCD for the treatment group and control group, at each visit after baseline : 1 month, 3 months, 6 months and 12 months
Time frame: 1 Year
Occurrence of Adverse events during the study
Safety of Bosentan in patients with Intermittent Claudication due Peripheral Arterial Disease.
Time frame: 1 Year
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