NCT02482207

Brief 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 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 .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P25-P50 for phase_4 hypertension

Timeline
Completed

Started Nov 2015

Longer than P75 for phase_4 hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 22, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 26, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 26, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 26, 2019

Completed
Last Updated

January 13, 2021

Status Verified

January 1, 2021

Enrollment Period

4.1 years

First QC Date

June 22, 2015

Last Update Submit

January 11, 2021

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

  • Difference of Coronary flow velocity reserve

    Averaged value of coronary flow velocity reserve will be obtained at 1 year follow-up

    1 year follow-up

Secondary Outcomes (3)

  • Change of coronary flow velocity reserve

    1 year follow-up

  • Change of LDL cholesterol

    1 year follow-up

  • Change of C reactive protein (CRP)

    1 year follow-up

Study Arms (2)

Rosuvastatin

EXPERIMENTAL

Rosuvastatin 10 mg qd for 1 year and life style modification

Drug: RosuvastatinBehavioral: Life style modification

Placebo

PLACEBO COMPARATOR

Life style modification alone

Behavioral: Life style modification

Interventions

RosuvastatinDRUG
Rosuvastatin
Life style modificationBEHAVIORAL
PlaceboRosuvastatin

Eligibility Criteria

Age35 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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: 25159238BACKGROUND

MeSH Terms

Conditions

Hypertension

Interventions

Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsSulfonesSulfur CompoundsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 22, 2015

First Posted

June 26, 2015

Study Start

November 1, 2015

Primary Completion

November 26, 2019

Study Completion

November 26, 2019

Last Updated

January 13, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)