Rosuvastatin Effect on Serial Echocardiographic Measurement of Coronary Flow Velocity Reserve

NCT01490398 | Completed Phase 4

• 1 other identifier: 2011-0865
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Hypertension; Cardiovascular Risk Factors

Keywords

Hypertension; Rosuvastatin; Coronary flow reserve

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Secondary Outcomes (3)

• Change of averaged peak diastolic velocity

  12 months

• Change of CRP

  12 months

• Change of LDL cholesterol

  12 months

Study Arms (1)

Rosuvastatin

EXPERIMENTAL

Rosuvastatin 10mg qd for 12 months.

Drug: Rosuvastatin

Interventions

Rosuvastatin DRUG

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.

Also known as: Crestor

Rosuvastatin

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Asan Medical Center: lead
• AstraZeneca: collaborator

Study Sites (1)

Asan Medical Center

Seoul, 138-736, South Korea

Location

Related Publications (1)

• 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.

  PMID: 25159238 DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Duk Hyun Kang, MD, PhD

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 9, 2011
• First Posted: December 13, 2011
• Study Start: December 1, 2011
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: May 9, 2014

Record last verified: 2014-05

Locations

KR (1)