Effect of olmesaRtan on Walking distancE and quaLIty of lifE in Peripheral Artery Disease Patients With Hypertension Treated For Intermittent Claudication (RELIEF)

Phase 4

Terminated

• Conditions: Peripheral Artery Disease With Intermittent Claudication
• Interventions: Drug: other anti-hypertensive drug; Drug: Olmesartan

• Registration Number: NCT02373462
• Lead Sponsor: Yonsei University

Brief Summary

To study the effect of olmesartan on walking distance and quality of life in peripheral artery disease patients with hypertension treated For intermittent claudication.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-02-14
• Study First Submitted QC: 2015-02-22
• Study First Posted: 2015-02-27
• Study Start: 2015-08-25
• Primary Completion: 2015-11-17
• Study Completion: 2015-11-17
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-24
• Last Update Posted: 2019-01-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
other group	other anti-hypertensive drug	other anti-hypertensive drug (titrating BP \<140/90 mmHg)
olmesartan group	Olmesartan	olmesartan (20mg qd then 40mg qd for titrating BP \<140/90 mmHg)

Primary Outcome Measures

Name	Time	Method
Pain free maximum walking distance and time	12th week	Effect of olmesartan in maximum, pain free walking distance \& time

Secondary Outcome Measures

Name	Time	Method
Quality of life as measured by questionnaires	24th week	Effect of olmesartan in quality of life (WIQ, SF-36)

Trial Locations

Locations (1)

Division of Cardiology, Department of Internal Medicine, Severance Hospital; 🇰🇷 Seoul, Korea, Republic of