An Advanced Echocardiographic Evaluation of Nebivolol

Hypertension Clinical Trial

Official title:

An Advanced Echocardiographic Evaluation of Nebivolol

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01206439
• Other study ID #: UC- 09-12-31-04
• Status: Terminated
• Phase: Phase 4
• First received: April 2, 2010
• Last updated: February 13, 2018
• Start date: September 2010
• Est. completion date: August 2012

Study information

• Verified date: February 2018
• Source: University of Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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 -

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• nebivolol
nebivolol 5 or 10 mg oral, daily

Locations

Country	Name	City	State
United States	University of Cincinnati	Cincinnati	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Jack Rubinstein	Forest Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Systolic and Diastolic Myocardial Function	Cannot report as only 1 patient was evaluated and data will not be able to remain anonymous.	Baseline to day 180
Secondary	Exercise Tolerance	Changes in exercise tolerance and time from baseline to 180 days.	Baseline to day 180.