- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02482207
Effect of Rosuvastatin on Coronary Flow Reserve in Hypertensive Patients With Cardiovascular Risk (RESERVE II)
A Randomized, Double-blind, Active-controlled Study to Assess the Effect of Rosuvastatin on Coronary Flow Reserve in Hypertensive Patients With Cardiovascular Risk
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Statin therapy improves coronary flow reserve (CFR) and decreases cardiac morbidity and mortality in patients with coronary artery disease (CAD) and hypercholesterolemia via pleiotropic effects of statins, including regression of atheroma, stabilization of atherosclerotic plaques. Lipid lowering with a statin also provided beneficial effects in hypertensive patients with average levels of serum total cholesterol in the Anglo-Scandinavian Cardiac Outcomes Trial-Lipid Lowering Arm (ASCOT-LLA). Improvements in endothelial dysfunction and CFR may be related to the beneficial effects of statins in hypertensive patients without hypercholesterolemia.
Previously CFR could be invasively measured using a Doppler guide wire in a cardiac catheterization laboratory, but recent advances in echocardiographic imaging techniques have made it feasible to measure CFR noninvasively in patients without CAD, which highly correlates with the CFR measured by invasive means.Accordingly, investigators recently demonstrated that CFR significantly improved after rosuvastatin therapy in hypertensive patients with average levels of serum cholesterol by measuring the change in CFR after 1 year treatment with rosuvastatin and also found a weak correlation between the change of CFR and the change of LDL cholesterol in the RESERVE (Rosuvastatin Effect on Coronary Flow Reserve in Hypertensive Patients) I trial. However, this trial could not include placebo-control group due to the limited study budget. Although CFR was measured by blinded, batch reading of stored echocardiographic images, bias in measurement might affect the result. In our previous study, study patients continued taking their antihypertensive medications and were educated to follow lifestyle modification during the study period, which may have influenced the change in CFR during follow-up, and the absence of a placebo group made it difficult to exclude the possibility that lifestyle modification and antihypertensive medication also played a role in improving CFR. Investigators hypothesize that rosuvastatin added to lifestyle modification will be superior to lifestyle modification alone in improving CFR in controlled hypertensive patients with cardiovascular risk, and try to examine this hypothesis in a double-blind, randomized comparison study using echocardiography.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Seoul, Korea, Republic of, 138-736
- Asan Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Controlled Hypertension: treated SBP<140 mmHg and DBP<90 mmHg with angiotensin receptor blocker (ACE inhibitor) and/or calcium channel blocker LDL cholesterol ≥ 130mg/dL
- Patients with statin-naive state, defined as receiving no statin therapy for more than 6 months during the previous 12 months.
- Any 1 of these cardiovascular risk factors required: smoking, age over 55 (men) or 65 (women), history of cerebrovascular event, family history of early coronary heart disease before age 55, HDL cholesterol < 40 mg/dL
- The patient agrees to the study protocol and the schedule of clinical and echocardiographic follow-up, and provides informed, written consent, as approved by the Institutional Review Board
Exclusion Criteria:
- A previous history of intolerance or hypersensitivity to statins
- Uncontrolled hypertension; SBP≥140 mmHg or DBP≥90 mmHg
- Previous myocardial infarction or currently treated angina pectoris
- Stroke, transient ischemic attack < 3 months
- Secondary hypertension
- Diabetes mellitus
- Peripheral vascular disease
- Fasting serum triglyceride > 500 mg/dL
- Clinical congestive heart failure
- Uncontrolled arrhythmia
- Left ventricular hypertrophy: LV mass index >134g/m2 (male) or >110g/m2 (female)
- Concomitant clinically important hematological, gastrointestinal, hepatic, renal or other disease
- Pregnant or lactating women and those of child-bearing potential
- Unwillingness or inability to comply with the procedures described in this protocol
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Rosuvastatin
Rosuvastatin 10 mg qd for 1 year and life style modification
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Placebo Comparator: Placebo
Life style modification alone
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Difference of Coronary flow velocity reserve
Time Frame: 1 year follow-up
|
Averaged value of coronary flow velocity reserve will be obtained at 1 year follow-up
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1 year follow-up
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of coronary flow velocity reserve
Time Frame: 1 year follow-up
|
Change of coronary flow velocity reserve from baseline to 1 year follow-up
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1 year follow-up
|
Change of LDL cholesterol
Time Frame: 1 year follow-up
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Change of LDL cholesterol from baseline to 1 year follow-up
|
1 year follow-up
|
Change of C reactive protein (CRP)
Time Frame: 1 year follow-up
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Change of CRP from baseline to 1 year follow-up
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1 year follow-up
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015-0610
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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