Peripheral Arterial Disease
Conditions
Keywords
Bosentan, Peripheral Arterial Disease
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.
Interventions
DRUGBosentan
Bosentan 62.5 mg/12 hours (first four weeks) and 125 mg/12 hours (eight weeks)
DRUGAntiaggregant therapy
AAS 100mg/d or Clopidogrel 75mg/d
DRUGStatins
Sponsors
Hospital Universitario Getafe
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
MALE
Age
50 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Absolute Claudication Distance (ACD) respect baseline values | 1 Year | 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 |
| Change in flow-mediated arterial dilation (FMAD) respect baseline values | 1 Year | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in the ankle brachial index (ABI) respect baseline values | 1 Year | 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 |
| Occurrence of Adverse events during the study | 1 Year | Safety of Bosentan in patients with Intermittent Claudication due Peripheral Arterial Disease. |
| Change in subjective claudication distance (SCD) reported by the patient, as is defined in the Walking Impairment Questionnaire (WIQ), respect baseline values | 1 Year | 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 |
| Changes in Analytical plasma values at each visit respect baseline values | 1 Year | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in the serum levels of Endothelin (ET) respect baseline values | 1 Year | To determine the efficacy of bosentan on the improvement in the endothelin function in patients with Intermittent Claudication due Peripheral Arterial Disease |
| Change in the serum levels of C-reactive protein (CRP) respect baseline values | 1 Year | To determine the efficacy of bosentan on the improvement in inflammatory status in patients with Intermittent Claudication due Peripheral Arterial Disease. CRP for the treatment group and control group, at each visit after baseline : 1 month, 3 months, 6 months and 12 months |
Countries
Spain
Outcome results
None listed