Can Nebivolol Reverse Inappropriate Left Ventricular Mass in Hypertensive Patients?

• Status: Terminated
• Trial end date: 2013-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate if a drug called nebivolol can reverse inappropriate left ventricular mass (LVM) when compared to the standard of care drug metoprolol.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Collaborator: Forest Laboratories
• Treatments: Metoprolol; Nebivolol

Criteria

All candidates must have previously untreated hypertension. The candidates will be picked from patients with stage-1 hypertension (systolic BP 140-159 mm Hg or diastolic BP 90-99 mm Hg) and those with stage-2 hypertension (systolic BP ≥160 mm Hg or diastolic BP ≥100), based on the seventh report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure guidelines (JNC-7).

Inclusion Criteria:

• Presence of inappropriate LVM.

• Presence of phenotype of inappropriate LVM.

Exclusion Criteria:

The criteria will assure that only patients with hypertension are enrolled, that is, excluded will be subjects with systolic BP < 140 or diastolic BP < 90 (ie, prehypertension or normal BP), but without complications or any indication (or suspicion) of end-organ damage based on a physical exam, clinical history, or laboratory tests.

Specific exclusion criteria are:

• Reactive airways disease including asthma.

• Diabetes mellitus or hypoglycemia; thyrotoxicosis.

• LV dysfunction (ejection fraction < 50%) or heart failure.

• Present or previously documented coronary heart disease or angina.

• Acute myocardial infarction, or history of myocardial infarction.

• Severe bradycardia, heart block greater than first degree or sick sinus syndrome (unless a permanent pacemaker is in place).

• Hepatic insufficiency or history of cirrhosis.

• Chronic renal failure or renovascular dysfunction.

• Cerebrovascular dysfunction.

• Peripheral vascular disease.

• Pregnant or nursing women; women of childbearing age will be required to take a pregnancy test at the time of enrollment and use an acceptable method of birth control.

• Poor echo image quality.