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| ID | Type | Description | Link |
|---|---|---|---|
| E.C.13/2009.CEIC10 | Other Grant/Funding Number | E.C.13/2009.CEIC10 |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Antiaggregants & Statins & Antihypertensives & Bosentan | Experimental | Bosentan 62.5 mg/12 hours (first four weeks) and 125 mg/12 hours (eight weeks) plus Antiaggregant therapy (AAS 100mg/d or Clopidogrel 75mg/d), Statins and Antihypertensive therapy |
|
| Antiaggregants & Statins & Antihypertensives | Active Comparator | Antiaggregant therapy (AAS 100 mg/d or Clopidogrel 75 mg/d), Statins, Antihypertensive therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bosentan | Drug | Bosentan 62.5 mg/12 hours (first four weeks) and 125 mg/12 hours (eight weeks) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 1 Year |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 1 Year |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the serum levels of Endothelin (ET) respect baseline values | To determine the efficacy of bosentan on the improvement in the endothelin function in patients with Intermittent Claudication due Peripheral Arterial Disease | 1 Year |
| Change in the serum levels of C-reactive protein (CRP) respect baseline values |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| De Haro Joaquin, MD, PhD | Hospital Universitario de Getafe | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario de Getafe | Getafe | Madrid | 28901 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26651453 | Derived | 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. |
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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000077300 | Bosentan |
| D019161 | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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| Antiaggregant therapy | Drug | AAS 100mg/d or Clopidogrel 75mg/d |
|
| Statins | Drug |
|
| Antihypertensive therapy | Drug |
|
| 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 |
| 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 | 1 Year |
| Occurrence of Adverse events during the study | Safety of Bosentan in patients with Intermittent Claudication due Peripheral Arterial Disease. | 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 |
| 1 Year |
| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000924 | Anticholesteremic Agents |
| D000960 | Hypolipidemic Agents |
| D000963 | Antimetabolites |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D004791 | Enzyme Inhibitors |
| D057847 | Lipid Regulating Agents |
| D045506 | Therapeutic Uses |