Effect of Pitavastatin on Coronary Flow Reserve in Hypertensive Patients

NCT ID: NCT02144922

Last Updated: 2016-10-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 85 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2016-10-31

Brief 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.

Detailed 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.

Conditions

Hypertension; Cardiovascular Risk

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Control

Patients continue taking their antihypertensive medication alone.

Group Type: PLACEBO_COMPARATOR

Control

Intervention Type: OTHER

Life style modification alone

Pitavastatin

Pitavastatin 4 mg is given to study patients after a baseline assessment and continued for 1 year without further dose titration. Patients continue taking their antihypertensive medication during the entire follow-up period.

Group Type: ACTIVE_COMPARATOR

Pitavastatin

Intervention Type: DRUG

statin

Interventions

Pitavastatin

statin

Intervention Type: DRUG

Control

Life style modification alone

Intervention Type: OTHER

Other Intervention Names

Livalo

Eligibility Criteria

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

JW Pharmaceutical

INDUSTRY

Sponsor Role: collaborator

Asan Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Duk-Hyun Kang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Duk-Hyun Kang, M.D.

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

Asan Medical Center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

2013-1091

Identifier Type: -

Identifier Source: org_study_id