An Advanced Echocardiographic Evaluation of Nebivolol

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.

Study Overview

• Status: Terminated
• Conditions: Hypertension
• Intervention / Treatment: Drug: nebivolol

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 Type: Interventional
• Enrollment (Actual): 2
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45267
      • University of Cincinnati

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nebivolol 5 or 10 mg, oral, daily; Subject will receive either 5 or 10 mg of oral nebivolol daily. Dose will be determined by control of blood pressure.	Drug: nebivolol; nebivolol 5 or 10 mg oral, daily; Other Names: Bystolic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exercise Tolerance	Changes in exercise tolerance and time from baseline to 180 days.	Baseline to day 180.

Collaborators and Investigators

• Sponsor: Jack Rubinstein
• Collaborators: Forest Laboratories
• Investigators: Principal Investigator: Jack Rubinstein, MD, University of Cincinnati

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): August 1, 2012
• Study Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: April 2, 2010
• First Submitted That Met QC Criteria: September 20, 2010
• First Posted (Estimate): September 21, 2010

Study Record Updates

• Last Update Posted (Actual): February 15, 2018
• Last Update Submitted That Met QC Criteria: February 13, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Vasodilator Agents; Adrenergic Agonists; Adrenergic beta-Agonists; Adrenergic beta-1 Receptor Agonists; Nebivolol
• Other Study ID Numbers: UC- 09-12-31-04

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No