An Advanced Echocardiographic Evaluation of Nebivolol

Phase 4

Terminated

• Conditions: Hypertension
• Interventions: Drug: nebivolol

• Registration Number: NCT01206439
• Lead Sponsor: Jack Rubinstein

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2010-04-02
• Study Start: 2010-09
• Study First Submitted QC: 2010-09-20
• Study First Posted: 2010-09-21
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Results First Submitted: 2015-08-24
• Results First Submitted QC: 2015-10-22
• Results First Posted: 2015-11-25
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-13
• Last Update Posted: 2018-02-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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 -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Change in Systolic and Diastolic Myocardial Function	Baseline to day 180	Cannot report as only 1 patient was evaluated and data will not be able to remain anonymous.

Secondary Outcome Measures

Name	Time	Method
Exercise Tolerance	Baseline to day 180.	Changes in exercise tolerance and time from baseline to 180 days.

Trial Locations

Locations (1)

University of Cincinnati; 🇺🇸 Cincinnati, Ohio, United States