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An Advanced Echocardiographic Evaluation of Nebivolol

Primary Purpose

Hypertension

Status

Terminated

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

nebivolol

About this trial

This is an interventional treatment trial for Hypertension

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Physical limitations resulting in a limited ability to walk on treadmill for stress echo
Intolerance to beta blockers
On more than one medication for the treatment of hypertension unless the second medication is a diuretic.
Currently pregnant or breast feeding.
LFT > 3 X ULN
HgA1C > 7
Participation in other clinical research studies involving the evaluation of other investigational drugs or devices within past 30 days of enrollment
Unwilling to follow protocol or return for study related procedures.
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
Any other medical condition that in the PI's opinion could affect myocardial function.
Current ETOH or illicit drug abuse -

Sites / Locations

University of Cincinnati

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Nebivolol 5 or 10 mg, oral, daily

Arm Description

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

Outcomes

Primary Outcome Measures

Change in Systolic and Diastolic Myocardial Function

Cannot report as only 1 patient was evaluated and data will not be able to remain anonymous.

Secondary Outcome Measures

Exercise Tolerance

Changes in exercise tolerance and time from baseline to 180 days.

Full Information

NCT ID

NCT01206439

First Posted

April 2, 2010

Last Updated

February 13, 2018

Sponsor

Jack Rubinstein

Collaborators

Forest Laboratories

1. Study Identification

Unique Protocol Identification Number

NCT01206439

Brief Title

An Advanced Echocardiographic Evaluation of Nebivolol

Official Title

An Advanced Echocardiographic Evaluation of Nebivolol

Study Type

Interventional

2. Study Status

Record Verification Date

February 2018

Overall Recruitment Status

Terminated

Why Stopped

Slow enrollment

Study Start Date

September 2010 (undefined)

Primary Completion Date

August 2012 (Actual)

Study Completion Date

August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Jack Rubinstein

Collaborators

Forest Laboratories

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertension

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

2 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Nebivolol 5 or 10 mg, oral, daily

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

nebivolol

Other Intervention Name(s)

Bystolic

Intervention Description

nebivolol 5 or 10 mg oral, daily

Primary Outcome Measure Information:

Title

Change in Systolic and Diastolic Myocardial Function

Description

Cannot report as only 1 patient was evaluated and data will not be able to remain anonymous.

Time Frame

Baseline to day 180

Secondary Outcome Measure Information:

Title

Exercise Tolerance

Description

Changes in exercise tolerance and time from baseline to 180 days.

Time Frame

Baseline to day 180.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Diagnosis of hypertension Written informed consent before initiation of any study related procedure Baseline Blood pressure > 140 systolic or >90 diastolic if on no antihypertensive therapy. Currently taking one antihypertensive or one antihypertensive and one diuretic for the treatment of hypertension. Exclusion Criteria: Physical limitations resulting in a limited ability to walk on treadmill for stress echo Intolerance to beta blockers On more than one medication for the treatment of hypertension unless the second medication is a diuretic. Currently pregnant or breast feeding. LFT > 3 X ULN HgA1C > 7 Participation in other clinical research studies involving the evaluation of other investigational drugs or devices within past 30 days of enrollment Unwilling to follow protocol or return for study related procedures. 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 Any other medical condition that in the PI's opinion could affect myocardial function. Current ETOH or illicit drug abuse -

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jack Rubinstein, MD

Organizational Affiliation

University of Cincinnati

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Cincinnati

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45267

Country

United States

12. IPD Sharing Statement

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An Advanced Echocardiographic Evaluation of Nebivolol

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