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

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ClinicalTrials.gov Identifier: NCT02373462
Recruitment Status : Terminated (The data of the paper referenced in the preparation of the protocols in this task were manipulated and the paper was withdrawn.)
First Posted : February 27, 2015
Last Update Posted : January 28, 2019
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Peripheral Artery Disease With Intermittent Claudication Drug: Olmesartan Drug: other anti-hypertensive drug Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Actual Study Start Date : August 25, 2015
Actual Primary Completion Date : November 17, 2015
Actual Study Completion Date : November 17, 2015

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Arms and Interventions
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Arm Intervention/treatment
Experimental: olmesartan group
olmesartan (20mg qd then 40mg qd for titrating BP <140/90 mmHg)
 Drug: Olmesartan
Active Comparator: other group
other anti-hypertensive drug (titrating BP <140/90 mmHg)
 Drug: other anti-hypertensive drug
CCB, diuretics, alpha blocker, direct vasodilator, beta blocker


Outcome Measures
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Primary Outcome Measures :
  1. Pain free maximum walking distance and time [ Time Frame: 12th week ]
    Effect of olmesartan in maximum, pain free walking distance & time


Secondary Outcome Measures :
  1. Quality of life as measured by questionnaires [ Time Frame: 24th week ]
    Effect of olmesartan in quality of life (WIQ, SF-36)


Other Outcome Measures:
  1. Pulse wave analysis as measured by PWV [ Time Frame: 24th week ]
    pulse wave velocity

  2. Blood pressure by measured by 24hr ABPM [ Time Frame: 24th week ]
    24hr ambulatory blood pressure monitoring


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02373462


Locations
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Korea, Republic of
Division of Cardiology, Department of Internal Medicine, Severance Hospital
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University
More Information
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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT02373462    
Other Study ID Numbers: 4-2014-0888
First Posted: February 27, 2015    Key Record Dates
Last Update Posted: January 28, 2019
Last Verified: January 2019
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Intermittent Claudication
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
 Peripheral Vascular Diseases
Olmesartan
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action