HypertensionPhase 4RESERVE IINCT02482207
Effect of Rosuvastatin on Coronary Flow Reserve in Hypertensive Patients With Cardiovascular Risk
A Phase 4 study testing Rosuvastatin and Life style modification in people with Hypertension, run by Asan Medical Center at 1 site in South Korea.
Trial summary
Investigators recently demonstrated that coronary flow reserve (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 in the RESERVE (Rosuvastatin Effect on Coronary Flow Reserve… Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Rosuvastatin and Life style modification
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2015to 26 Nov 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Active-controlled Study to Assess the Effect of Rosuvastatin on Coronary Flow Reserve in Hypertensive Patients With Cardiovascular Risk
Investigators recently demonstrated that coronary flow reserve (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 in the RESERVE (Rosuvastatin Effect on Coronary Flow Reserve in Hypertensive Patients) I trial. However, 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 in our previous study. In a double-blind, randomized trial, investigators try to examine the hypothesis that rosuvastatin added to lifestyle modification will be superior to lifestyle modification alone in improving CFR in hypertensive patients .
Read the 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.
- Conditions
- Hypertension
- Being tested
- Rosuvastatin, Life style modification
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RosuvastatinDrug
Life style modificationBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Rosuvastatin | Experimental | Rosuvastatin 10 mg qd for 1 year and life style modification Receives: Drug: Rosuvastatin; Behavioral: Life style modification |
| Placebo | Placebo comparator | Life style modification alone Receives: Behavioral: Life style modification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference of Coronary flow velocity reserve
Averaged value of coronary flow velocity reserve will be obtained at 1 year follow-up
Measured: 1 year follow-up
Secondary outcomes (3)
Change of coronary flow velocity reserve
Change of coronary flow velocity reserve from baseline to 1 year follow-up
Measured: 1 year follow-up
Change of LDL cholesterol
Change of LDL cholesterol from baseline to 1 year follow-up
Measured: 1 year follow-up
Change of C reactive protein (CRP)
Change of CRP from baseline to 1 year follow-up
Measured: 1 year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2015 (estimated)
- Study startNov 2015
- Primary completion26 Nov 2019
- Study completion26 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Dong-A ST Co., Ltd.
- Responsible party
- Principal investigator, Duk-Hyun Kang, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02482207
- Sponsor's protocol ID
- 2015-0610
- Acronym
- RESERVE II
- Status last verified
- Jan 2021
- First submitted
- 22 Jun 2015
- Last updated
- 13 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Sun BJ, Hwang E, Jang JY, Kim DH, Song JM, Kang DH. Effect of rosuvastatin on coronary flow reserve in patients with systemic hypertension. Am J Cardiol. 2014 Oct 15;114(8):1234-7. doi: 10.1016/j.amjcard.2014.07.046. Epub 2014 Jul 30.
PubMed 25159238
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Active-controlled Study to Assess the Effect of Rosuvastatin on Coronary Flow Reserve in Hypertensive Patients With Cardiovascular Risk
- ClinicalTrials.gov ID
- NCT02482207
- Acronym / sponsor ID
- RESERVE II / 2015-0610
- Conditions
- Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Collaborators
- Dong-A ST Co., Ltd.
- Study start
- Nov 2015 (actual)
- Primary completion
- 26 Nov 2019 (actual)
- Study completion
- 26 Nov 2019 (actual)
- First posted
- 26 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Investigators recently demonstrated that coronary flow reserve (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 in the RESERVE (Rosuvastatin Effect on Coronary Flow Reserve in Hypertensive Patients) I trial. However, 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 in our previous study. In a double-blind, randomized trial, investigators try to examine the hypothesis that rosuvastatin added to lifestyle modification will be superior to lifestyle modification alone in improving CFR in hypertensive patients .
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rosuvastatin | Experimental | Drug: Rosuvastatin, Behavioral: Life style modificationRosuvastatin 10 mg qd for 1 year and life style modification |
| Placebo | Placebo comparator | Behavioral: Life style modificationLife style modification alone |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rosuvastatin | Drug | Rosuvastatin |
| Life style modification | Behavioural | Placebo, Rosuvastatin |
Primary outcome
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
3 secondary outcomes
Change of coronary flow velocity reserve
Time frame: 1 year follow-up
Change of LDL cholesterol
Time frame: 1 year follow-up
Change of C reactive protein (CRP)
Time frame: 1 year follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2021.
- Background: PubMed 25159238Sun BJ, Hwang E, Jang JY, Kim DH, Song JM, Kang DH. Effect of rosuvastatin on coronary flow reserve in patients with systemic hypertension. Am J Cardiol. 2014 Oct 15;114(8):1234-7. doi: 10.1016/j.amjcard.2014.07.046. Epub 2014 Jul 30.
- Individual participant dataSharing planned: No
Related trials for Hypertension
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rosuvastatin and Life style modification in people with Hypertension, run by Asan Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference of Coronary flow velocity reserve (time frame: 1 year follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02482207, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2021.