An Advanced Echocardiographic Evaluation of Nebivolol

Jack Rubinstein

Status and phase: Terminated; Phase 4

Conditions: Hypertension

Treatments: Drug: nebivolol

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01206439

UC- 09-12-31-04

Details and patient eligibility

About

The purpose of this study is to determine if Nebivolol has any effect on heart function determined by changes in echocardiographic data or exercise tolerance.

Full description

Subjects will be given either 5 or 10 mg daily of oral Nebivolol for blood pressure control. They will undergo stress echocardiography at baseline, day 14, 90 and 180.

Enrollment: 2 patients

Sex: All

Ages: 20 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Diagnosis of hypertension
2. Written informed consent before initiation of any study related procedure
3. Baseline Blood pressure > 140 systolic or >90 diastolic if on no antihypertensive therapy.
4. Currently taking one antihypertensive or one antihypertensive and one diuretic for the treatment of hypertension.

Exclusion criteria

1. Physical limitations resulting in a limited ability to walk on treadmill for stress echo

2. Intolerance to beta blockers

3. On more than one medication for the treatment of hypertension unless the second medication is a diuretic.

4. Currently pregnant or breast feeding.

5. LFT > 3 X ULN

6. HgA1C > 7

7. Participation in other clinical research studies involving the evaluation of other investigational drugs or devices within past 30 days of enrollment

8. Unwilling to follow protocol or return for study related procedures.

9. Any of the following conditions:

   Coronary artery disease Heart failure Valvular heart disease Ischemic heart disease Atrial fibrillation Pacemaker ICD Hyperlipidemia Diabetes Mellitus Stroke/TIA Anemia COPD Asthma Renal failure requiring dialysis Liver failure Cirrhosis Thyroid dysfunction

10. Any other medical condition that in the PI's opinion could affect myocardial function.

11. Current ETOH or illicit drug abuse -

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2 participants in 1 patient group

Nebivolol 5 or 10 mg, oral, daily

Experimental group

Description:

Subject will receive either 5 or 10 mg of oral nebivolol daily. Dose will be determined by control of blood pressure.

Treatment:

Drug: nebivolol