Effect of Pitavastatin on Coronary Flow Reserve in Hypertensive Patients

Hypertension Clinical Trial

— EPOCH  

Official title:

Effect of Pitavastatin on Coronary Flow Reserve in Hypertensive Patients With Cardiovascular Risk

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02144922
• Other study ID #: 2013-1091
• Status: Completed
• Phase: Phase 4
• First received: May 20, 2014
• Last updated: October 13, 2016
• Start date: May 2014
• Est. completion date: October 2016

Study information

• Verified date: October 2016
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Although statins reduce cardiac events in hypertensive patients with cardiovascular risk factors, the effect of statins on coronary flow reserve (CFR) has not been examined in such patients. The investigators hypothesize that pitavastatin added to standard antihypertensive therapy will be superior to placebo in improving CFR in hypertensive patients with cardiovascular risk, and try to examine this hypothesis in a double-blind, randomized comparison study using Doppler echocardiography.

Description:

Statin treatment improves coronary flow reserve (CFR) and decreases cardiac morbidity and mortality in patients with coronary artery disease (CAD) and hypercholesterolemia. Endothelial dysfunction and impairment in coronary microcirculation is also observed in hypertensive patients with cardiovascular risk factors. However, the measurement of CFR has rarely been performed in hypertensive patients without CAD, because CFR could be invasively measured using a Doppler guide wire in a cardiac catheterization laboratory. Recent advances in echocardiographic imaging techniques have made it possible to measure coronary flow velocity and CFR, which highly correlates with the CFR measured by invasive means.

Lipid lowering with a statin provided beneficial effects in patients with average levels of serum total cholesterol in the Anglo-Scandinavian Cardiac Outcomes Trial-Lipid Lowering Arm (ASCOT-LLA) study conducted in hypertensive patients at cardiovascular risk. Improvements in endothelial dysfunction and CFR may be related to the beneficial effects of statins in hypertensive patients without hypercholesterolemia, but the effect of statins on CFR has not been examined in such patients. Accordingly, the investigators try to examine the hypothesis that pitavastatin added to standard antihypertensive therapy in hypertensive patients with cardiovascular risk will be superior to placebo in improving CFR in a double-blind, randomized comparison study using Doppler echocardiography.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 80 Years

Eligibility

Inclusion Criteria:

• Controlled Hypertension: treated SBP<140 mmHg and DBP<90 mmHg

• 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 CHD before age 55, HDL cholesterol < 40 mg/dL

Exclusion Criteria:

• 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, TIA < 3 months

• Secondary hypertension

• 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

• Diabetes

• Peripheral vascular disease

• Unwillingness or inability to comply with the procedures described in this protocol

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Risk
• Hypertension

Intervention

Drug:
• Pitavastatin
statin

Other:
• Control
Life style modification alone

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Asan Medical Center	JW Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in the CFR value	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.	12 months	No
Primary	Difference in mean CFR value	DIfference in CFR value at 12 month follow-up between pitavastatin and placebo arm	12 months	No
Secondary	change of CRP	Change of CRP from baseline to 1 year follow-up.	12 months	No
Secondary	Change of LDL-cholesterol	Change of LDL-cholesterol from baseline to 1 year follow-up.	12 months	No
Secondary	Change of averaged peak diastolic velocity	Change of averaged peak diastolic velocity from baseline to study end.	12 months	No