HypertensionPhase 4RESERVENCT01490398
Rosuvastatin Effect on Serial Echocardiographic Measurement of Coronary Flow Velocity Reserve
A Phase 4 study testing Rosuvastatin in people with Hypertension and Cardiovascular Risk Factors, run by Asan Medical Center at 1 site in South Korea.
Trial summary
In ASCOT study, lipid lowering with a statin provided additional beneficial effects in hypertensive patients with average levels of serum total cholesterol. However, the underlying mechanism of statins to improve clinical outcomes in hypertension is unclear and the effect of statins on coronary flow reserve (CFR) has… Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Hypertension, Cardiovascular Risk Factors
- What is being tested?
- Rosuvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2011to Oct 2013
- 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
- LDL cholesterol > 130 mg/dL
- Patients with statin-naive state, defined as receiving no statin therapy for more than 3 months during the previous 12 months
- Any 1 of these cardiovascular risk factors required: smoking, Type 2 DM, age over 55 (men) or 65 (women), peripheral vascular disease, history of cerebrovascular event, family history of early CHD before age 55, HDL cholesterol < 40 mg/dL
Who cannot join
- A previous history of intolerance or hypersensitivity to statins
- Uncontrolled hypertension; SBP ≥ 140 mmHg or DBP ≥ 90 mmHg
- Previous MI or currently treated angina pectoris
- Stroke, Transient ischemic attack < 3 months
- Secondary hypertension
- Fasting serum triglyceride > 500 mg/dL
Show all 11Show fewer
- Clinical congestive heart failure
- Uncontrolled arrhythmia
- Left ventricular hypertrophy: LV mass index > 134g/m2 (male) or >110g/m2 (female)
- Concomitant clinically important respiratory, hematological, gastrointestinal, hepatic, renal or other disease
- Pregnant or lactating women and those of child-bearing potential
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Rosuvastatin on Coronary Flow Reserve in Hypertensive Patients
In ASCOT study, lipid lowering with a statin provided additional beneficial effects in hypertensive patients with average levels of serum total cholesterol. However, the underlying mechanism of statins to improve clinical outcomes in hypertension is unclear and the effect of statins on coronary flow reserve (CFR) has not been examined in hypertensive patients. Therefore, it is clinically important and timely project to measure CFR non-invasively using echocardiography and to elucidate the mechanism of clinical benefits of statins in hypertensive patients with cardiovascular risk. The investigators try to evaluate the effect of rosuvastatin on CFR by measuring the change of CFR after 1 year treatment of rosuvastatin, and to correlate CFR with LDL-cholesterol and CRP.
Read the detailed description
In hypertensive patients with high risk, lipid lowering with a statin provided additional beneficial effects in hypertensive patients with average levels of serum total cholesterol. However, the underlying mechanism of statins to improve clinical outcomes in hypertension is unclear. In patients with hypercholesterolemia or coronary atherosclerosis, several studies reported that level of LDL-cholesterol was inversely correlated with coronary blood flow reserve and suggested that statin improved coronary blood flow. Although it is speculated that statin may improve coronary blood flow by decreasing LDL cholesterol level and stabilizing atherosclerotic plaque in coronary atherosclerosis, the effect of statins on coronary flow reserve (CFR) has not been examined in hypertensive patients.
LDL cholesterol is expected to significantly decrease when rosuvastatin 20mg is administered. In addition to LDL-cholesterol lowering effect, the stabilization of atherosclerotic plaque and the regression of atheroma are observed during rosuvastatin treatment. Because of these beneficial effects of rosuvastatin, it may be expected that rosuvastatin will improve coronary blood flow even in hypertensive patients without hypercholesterolemia and the efficacy of rosuvastatin on CFR needs to be investigated in hypertensive patients with cardiovascular risk.
Morphologic assessment for the measurement of coronary lumen in the invasive coronary angiography is used as a gold standard to assess the stenosis in coronary diseases. However, as decrease of myocardial blood flow due to coronary artery disease could not be exactly evaluated by morphologic stenosis, the functional test was required to assess the significance of coronary artery stenosis, and CFR could be directly measured using Doppler guide wire since mid-1990s. Since the pathophysiological implication of coronary stenosis can be assessed using CFR measurement, CFR value is widely used in clinical practice as a very useful indicator to assess coronary stenosis severity in performing percutaneous coronary intervention. As a high frequency transducer with excellent resolution has been used, coronary artery can be directly imaged, and coronary flow velocity can be measured using echo-Doppler technique. As a result, CFR is easily measured in an echocardiography lab which could be measured only in a cardiac catheterization lab using Doppler guide wire in the past. It was confirmed that CFR values obtained by Doppler technique were same as those invasively obtained in a cardiac catheterization lab. The clinical usefulness and accuracy of the technique have been verified also in the diagnosis of coronary artery disease.
Therefore, it is clinically important and timely project to measure CFR non-invasively using echocardiography and to elucidate the mechanism of clinical benefits of statins in hypertensive patients with cardiovascular risk. We try to evaluate the effect of rosuvastatin on CFR by measuring the change of CFR after 1 year treatment of rosuvastatin, and to correlate CFR with LDL-cholesterol and CRP.
- Conditions
- Hypertension, Cardiovascular Risk Factors
- Being tested
- Rosuvastatin
- Keywords
- Hypertension, Rosuvastatin, Coronary flow reserve
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RosuvastatinDrug
Also called Crestor
After baseline assessment, the starting dose of rosuvastatin 10 mg will be given to study patients. If tolerated and LDL-C is > 100mg/dL after 2-4 weeks, the dose will be increased to 20 mg. Rosuvastatin treatment is scheduled to continue for 1 year without no further dose titration, and each patient will be followed at 2 months, 6 months and 1 year.
| Study group | Role | What they receive |
|---|---|---|
| Rosuvastatin | Experimental | Rosuvastatin 10mg qd for 12 months. Receives: Drug: Rosuvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of coronary flow velocity reserve
Change of coronary flow velocity reserve from baseline to 1 year follow-up. For each patient, the averaged value of coronary flow velocity reserve will be obtained at baseline and 1 year follow-up.
Measured: 12 months
Secondary outcomes (3)
Change of averaged peak diastolic velocity
Change of averaged peak diastolic velocity from baseline to study end.
Measured: 12 months
Change of CRP
Change of CRP from baseline to study end.
Measured: 12 months
Change of LDL cholesterol
Change of LDL cholesterol from baseline to study end.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionOct 2013
- Study completionOct 2013
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Principal investigator, Duk-Hyun Kang, Asan Medical Center
- Investigators
- Duk Hyun Kang, MD, PhD, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01490398
- Sponsor's protocol ID
- 2011-0865
- Acronym
- RESERVE
- Status last verified
- May 2014
- First submitted
- 9 Dec 2011
- Last updated
- 9 May 2014
- Results posted
- No
- Data monitoring committee
- 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 9 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Rosuvastatin on Coronary Flow Reserve in Hypertensive Patients
- ClinicalTrials.gov ID
- NCT01490398
- Acronym / sponsor ID
- RESERVE / 2011-0865
- Conditions
- Hypertension, Cardiovascular Risk Factors
- Keywords
- Hypertension, Rosuvastatin, Coronary flow reserve
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- Dec 2011
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 13 Dec 2011 (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.
In ASCOT study, lipid lowering with a statin provided additional beneficial effects in hypertensive patients with average levels of serum total cholesterol. However, the underlying mechanism of statins to improve clinical outcomes in hypertension is unclear and the effect of statins on coronary flow reserve (CFR) has not been examined in hypertensive patients. Therefore, it is clinically important and timely project to measure CFR non-invasively using echocardiography and to elucidate the mechanism of clinical benefits of statins in hypertensive patients with cardiovascular risk. The investigators try to evaluate the effect of rosuvastatin on CFR by measuring the change of CFR after 1 year treatment of rosuvastatin, and to correlate CFR with LDL-cholesterol and CRP.
Detailed description
In hypertensive patients with high risk, lipid lowering with a statin provided additional beneficial effects in hypertensive patients with average levels of serum total cholesterol. However, the underlying mechanism of statins to improve clinical outcomes in hypertension is unclear. In patients with hypercholesterolemia or coronary atherosclerosis, several studies reported that level of LDL-cholesterol was inversely correlated with coronary blood flow reserve and suggested that statin improved coronary blood flow. Although it is speculated that statin may improve coronary blood flow by decreasing LDL cholesterol level and stabilizing atherosclerotic plaque in coronary atherosclerosis, the effect of statins on coronary flow reserve (CFR) has not been examined in hypertensive patients.
LDL cholesterol is expected to significantly decrease when rosuvastatin 20mg is administered. In addition to LDL-cholesterol lowering effect, the stabilization of atherosclerotic plaque and the regression of atheroma are observed during rosuvastatin treatment. Because of these beneficial effects of rosuvastatin, it may be expected that rosuvastatin will improve coronary blood flow even in hypertensive patients without hypercholesterolemia and the efficacy of rosuvastatin on CFR needs to be investigated in hypertensive patients with cardiovascular risk.
Morphologic assessment for the measurement of coronary lumen in the invasive coronary angiography is used as a gold standard to assess the stenosis in coronary diseases. However, as decrease of myocardial blood flow due to coronary artery disease could not be exactly evaluated by morphologic stenosis, the functional test was required to assess the significance of coronary artery stenosis, and CFR could be directly measured using Doppler guide wire since mid-1990s. Since the pathophysiological implication of coronary stenosis can be assessed using CFR measurement, CFR value is widely used in clinical practice as a very useful indicator to assess coronary stenosis severity in performing percutaneous coronary intervention. As a high frequency transducer with excellent resolution has been used, coronary artery can be directly imaged, and coronary flow velocity can be measured using echo-Doppler technique. As a result, CFR is easily measured in an echocardiography lab which could be measured only in a cardiac catheterization lab using Doppler guide wire in the past. It was confirmed that CFR values obtained by Doppler technique were same as those invasively obtained in a cardiac catheterization lab. The clinical usefulness and accuracy of the technique have been verified also in the diagnosis of coronary artery disease.
Therefore, it is clinically important and timely project to measure CFR non-invasively using echocardiography and to elucidate the mechanism of clinical benefits of statins in hypertensive patients with cardiovascular risk. We try to evaluate the effect of rosuvastatin on CFR by measuring the change of CFR after 1 year treatment of rosuvastatin, and to correlate CFR with LDL-cholesterol and CRP.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rosuvastatin | Experimental | Drug: RosuvastatinRosuvastatin 10mg qd for 12 months. |
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
- LDL cholesterol > 130 mg/dL
- Patients with statin-naive state, defined as receiving no statin therapy for more than 3 months during the previous 12 months
- Any 1 of these cardiovascular risk factors required: smoking, Type 2 DM, age over 55 (men) or 65 (women), peripheral vascular disease, history of cerebrovascular event, family history of early CHD before age 55, HDL cholesterol < 40 mg/dL
Key exclusion criteria (11 listed)
- A previous history of intolerance or hypersensitivity to statins
- Uncontrolled hypertension; SBP ≥ 140 mmHg or DBP ≥ 90 mmHg
- Previous MI 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 |
|---|---|---|
| RosuvastatinAlso: CrestorAfter baseline assessment, the starting dose of rosuvastatin 10 mg will be given to study patients. If tolerated and LDL-C is > 100mg/dL after 2-4 weeks, the dose will be increased to 20 mg. Rosuvastatin treatment is scheduled to continue for 1 year without no further dose titration, and each patient will be followed at 2 months, 6 months and 1 year. | Drug | Rosuvastatin |
Primary outcome
Change of coronary flow velocity reserve
Time frame: 12 months
Change of coronary flow velocity reserve from baseline to 1 year follow-up. For each patient, the averaged value of coronary flow velocity reserve will be obtained at baseline and 1 year follow-up.
3 secondary outcomes
Change of averaged peak diastolic velocity
Time frame: 12 months
Change of CRP
Time frame: 12 months
Change of LDL cholesterol
Time frame: 12 months
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 9 May 2014.
- Derived from this study: 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.
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.
Duk Hyun Kang, MD, PhD principal investigator
Asan Medical Center
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 in people with Hypertension and Cardiovascular Risk Factors, 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 11 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 9 May 2014. 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. 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?
Change of coronary flow velocity reserve (time frame: 12 months). 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 NCT01490398, 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 9 May 2014.