Back to resultsEffect of olmesaRtan on Walking distancE and quaLIty of lifE in Peripheral Artery Disease Patients With Hypertension Treated For Intermittent Claudication (RELIEF)
Primary Purpose
Peripheral Artery Disease With Intermittent Claudication
Status
Terminated
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Olmesartan
other anti-hypertensive drug
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral Artery Disease With Intermittent Claudication
Eligibility 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
Sites / Locations
- Division of Cardiology, Department of Internal Medicine, Severance Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
olmesartan group
other group
Arm Description
olmesartan (20mg qd then 40mg qd for titrating BP <140/90 mmHg)
other anti-hypertensive drug (titrating BP <140/90 mmHg)
Outcomes
Primary Outcome Measures
Pain free maximum walking distance and time
Effect of olmesartan in maximum, pain free walking distance & time
Secondary Outcome Measures
Quality of life as measured by questionnaires
Effect of olmesartan in quality of life (WIQ, SF-36)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02373462
Brief Title
Effect of olmesaRtan on Walking distancE and quaLIty of lifE in Peripheral Artery Disease Patients With Hypertension Treated For Intermittent Claudication (RELIEF)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Terminated
Why Stopped
The data of the paper referenced in the preparation of the protocols in this task were manipulated and the paper was withdrawn.
Study Start Date
August 25, 2015 (Actual)
Primary Completion Date
November 17, 2015 (Actual)
Study Completion Date
November 17, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Artery Disease With Intermittent Claudication
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
olmesartan group
Arm Type
Experimental
Arm Description
olmesartan (20mg qd then 40mg qd for titrating BP <140/90 mmHg)
Arm Title
other group
Arm Type
Active Comparator
Arm Description
other anti-hypertensive drug (titrating BP <140/90 mmHg)
Intervention Type
Drug
Intervention Name(s)
Olmesartan
Intervention Type
Drug
Intervention Name(s)
other anti-hypertensive drug
Intervention Description
CCB, diuretics, alpha blocker, direct vasodilator, beta blocker
Primary Outcome Measure Information:
Title
Pain free maximum walking distance and time
Description
Effect of olmesartan in maximum, pain free walking distance & time
Time Frame
12th week
Secondary Outcome Measure Information:
Title
Quality of life as measured by questionnaires
Description
Effect of olmesartan in quality of life (WIQ, SF-36)
Time Frame
24th week
Other Pre-specified Outcome Measures:
Title
Pulse wave analysis as measured by PWV
Description
pulse wave velocity
Time Frame
24th week
Title
Blood pressure by measured by 24hr ABPM
Description
24hr ambulatory blood pressure monitoring
Time Frame
24th week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Division of Cardiology, Department of Internal Medicine, Severance Hospital
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
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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