Effect of Nebivolol on the Blood Flow in Hearts of Adults With High Blood Pressure and Abnormal Filling of Heart

• Status: Completed
• Trial end date: 2016-03-01
• Target enrollment: 0
• Participant gender: All

Summary

To investigate whether treatment with Nebivolol in subjects with high blood pressure and abnormal filling of left ventricle (LVDD) improves exercise time by improving Left Ventricular deformation and filling.

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

Details

• Lead Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborator: Forest Laboratories
• Treatments: Nebivolol

Criteria

Inclusion Criteria:

• History of mild (140-160 / 90-100) to moderate (160-200 / 100-120) hypertension

• LV diastolic dysfunction (>/= Grade1)

• LV ejection fraction >50%

• Indexed left atrial volume >/= 28 mL/m^2

• In sinus rhythm at the time of enrollment

• Willingness to return for the 6-month follow up investigations

Exclusion Criteria:

• Presence or history of any of the following at baseline:

1. History of mitral valve disease of greater than mild severity or prosthetic mitral valve, congenital heart disease or permanent pacemaker

2. Calculated creatinine clearance <50 mL/min

3. Terminal Illness with expected Survival of <1 year

4. Previous Heart Transplant

5. Individuals who are institutionalized

6. Systolic BP>180 mm Hg or diastolic BP > 120 mm Hg

• Medical treatment for elevated BP with:

1. Calcium channel blocker (e.g. verapamil, nifedipine);

2. Alpha blocker (e.g. prazosin);

3. Alpha agonist (e.g. α-methyldopa, hydralazine, clonidine)

• Patient unwilling or unable to provide informed consent for study participation

• Pregnancy (current, or anticipated within the study period)

• Secondary Hypertension

• Previous echo contrast allergy

• Poor echocardiography window

• Previous stroke, known carotid stenosis

• Contraindication for beta-blocker therapy (sinus bradycardia <50 beats/min);

• 2nd or 3rd degree AV conduction block

• Overt congestive cardiac failure (NYHA Class III-IV)

• Known bronchospastic disease

• Known hepatic dysfunction (SGOT/PT > twice above normal levels)