Phase 3 N=287 Randomized Double-blind Treatment

The CLEVER Study - Coreg And Left Ventricular Mass Regression

Hypertrophy, Left Ventricular

Bottom Line

View on ClinicalTrials.gov: NCT00108082 ↗

Enrolled (actual)

287

Serious AEs

—

Results posted

Nov 2009

Primary outcome: Primary: Model-adjusted Mean Change From Baseline in Left Ventricular Mass Indexed (LVMI) by Body Surface Area as Measured by Magnetic Resonance Imaging (MRI) at Month 12 — -6.34; -6.67; -7.94 grams per meters squared (g/m^2) — p=0.7651

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: carvedilol MR (Drug); atenolol (Drug); lisinopril (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: GlaxoSmithKline
Primary completion: Aug 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Model-adjusted Mean Change From Baseline in Left Ventricular Mass Indexed (LVMI) by Body Surface Area as Measured by Magnetic Resonance Imaging (MRI) at Month 12	-6.34; -6.67; -7.94	0.7651
SECONDARY Model-adjusted Mean Change From Baseline in Left Ventricular Mass Indexed by Height (LVMIH) as Measured by MRI at Month 12	-3.19; -3.37; -3.98	—
SECONDARY Model-adjusted Mean Change From Baseline in Left Ventricular (LV) Mass as Measured by MRI at Month 12	-13.74; -14.17; -17.17	—
SECONDARY Model-adjusted Mean Change From Baseline in Left Ventricular Mass Indexed (LVMI) by Body Surface Area as Measured by Echocardiography at Month 12	-20.35; -20.06; -18.48	—
SECONDARY Model-adjusted Mean Change From Baseline in Left Ventricular Mass Indexed by Height (LVMIH) as Measured by Echocardiography at Month 12	-11.78; -12.51; -11.61	—
SECONDARY Model-adjusted Mean Change From Baseline in LV Mass as Measured by Echocardiography at Month 12	-45.76; -40.56; -38.58	—
SECONDARY Mean Change From Baseline in LV Filling Parameters as Measured by MRI at Month 12	0.364; 6.763; -3.406; -0.513; -0.565; 1.088	—
SECONDARY Model-adjusted Mean Change From Baseline in LV End Systolic and Diastolic Volumes and Ejection Fraction as Measured by MRI at Month 12	-1.44; -4.29; -3.04; -2.86; -2.45; -7.45	—
SECONDARY Model-adjusted Mean Change From Baseline in LV End Systolic and Diastolic Volumes and Ejection Fraction as Measured by Echocardiography at Month 12	-3.38; -4.74; -5.34; -3.07; -3.64; -9.37	—
SECONDARY Model-adjusted Mean Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at Month 12	-21.32; -21.12; -22.53; -12.77; -14.05; -11.13	—
SECONDARY Model-adjusted Ratio to Baseline as Percentage Change From Baseline in Log Transformed B-type Natriuretic Peptide (BNP) at Month 12	51.7; 48.3; -39.1	—
SECONDARY Model-adjusted Ratio to Baseline as Percentage Change From Baseline in Log Transformed C-Reactive Protein (CRP) at Month 12	-10.63; -3.22; 2.70	—
SECONDARY Percentage Change From Baseline in Log Transformed Lipid Parameters at Month 12	0.7; -1.3; -1.7; 0.0; -4.0; -2.7	—
SECONDARY Model-adjusted Ratio to Baseline as Percentage Change From Baseline in Log Transformed Albumin Creatinine Ratio (ACR) at Month 12	-27.1; -20.1; -21.5	—

Summary

This study is designed to compare the effects of COREG MR (carvedilol modified release formulation) to atenolol on indices of left ventricular dimensions when added to standardized angiotensin converting enzyme (ACE) inhibition, and to the effect of ACE inhibition alone. Subjects with LVH (left ventricular hypertrophy) and hypertension will be studied. The primary endpoint will be the change in left ventricular mass index (LVMI) characterized by magnetic resonance imaging (MRI) following 12 months of treatment. Secondary endpoints include the change in LV (left ventricular) mass, LV wall thickness, diastolic left ventricular filling parameters, and left ventricular ejection fraction by echocardiographic methods at Treatment Month 12. Composite outcomes and individual event data will also be evaluated by treatment group.

Eligibility Criteria

Inclusion criteria

Stage 1 or Stage 2 hypertension.
Left ventricular hypertrophy.

Exclusion criteria

In atrial fibrillation.
Takes beta-blocker for MI (myocardial infarction) or arrhythmia.
Has uncontrolled diabetes, uncontrollable or symptomatic arrhythmias, unstable angina, second or third degree heart block, history of MI, COPD (chronic obstructive pulmonary disease), liver or kidney disease.
Uses beta-2-agonists.
Unable to undergo MRI (magnetic resonance imaging).
Females of childbearing potential.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00108082). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.