Peripheral Artery Disease With Intermittent Claudication Clinical Trial
Verified date | January 2019 |
Source | Yonsei University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To study the effect of olmesartan on walking distance and quality of life in peripheral artery disease patients with hypertension treated For intermittent claudication.
Status | Terminated |
Enrollment | 1 |
Est. completion date | November 17, 2015 |
Est. primary completion date | November 17, 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 85 Years |
Eligibility |
Inclusion Criteria: - Aged between 20 and 85 years at visit 1 - Patients with ankle-brachial index (ABI) of less than 0.9 in one or both legs with history of intermittent claudication stable for the previous 6 months - Patients whose statins, anti hypertensive medications and antiplatelet medications are stable for the past 6 months. Statins and cilostazol are allowed but needs to be stable for the past 6 months (diabetic medications may be changed) - Patients whose blood pressure is more than 140/90 mmHg with/without anti-hypertension treatment Exclusion Criteria: - Blood pressure of more than 180/110 mmHg - Patients taking ARBs or ACE inhibitors treatment for at least 6 months before - Patients taking aldosterone receptor antagonists at least 6 months before - Patients with serum creatinine of more than 3 mg/dL - serum potassium (K+) > 5.5mg/dl - History of bilateral renal artery stenosis - History of acute coronary syndrome or heart failure hospitalization within 6 months - Peripheral arterial revascularization planned within 1 month - Critical limb ischemia - Patients with impaired cognition (e.g. dementia) - pregnancy or women at age of childbearing potential |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Division of Cardiology, Department of Internal Medicine, Severance Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Yonsei University |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Pulse wave analysis as measured by PWV | pulse wave velocity | 24th week | |
Other | Blood pressure by measured by 24hr ABPM | 24hr ambulatory blood pressure monitoring | 24th week | |
Primary | Pain free maximum walking distance and time | Effect of olmesartan in maximum, pain free walking distance & time | 12th week | |
Secondary | Quality of life as measured by questionnaires | Effect of olmesartan in quality of life (WIQ, SF-36) | 24th week |