An Advanced Echocardiographic Evaluation of Nebivolol

• Sponsor: Jack Rubinstein (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01206439
• Collaborator: Forest Laboratories (Industry)
• Enrollment: 2
• Location: 1
• Arm: 1
• Duration (Months): 23
• Patients Per Site Per Month: 0.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertension	Drug: nebivolol	Phase 4

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 Design

• Study Type: Interventional
• Actual Enrollment: 2 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Advanced Echocardiographic Evaluation of Nebivolol
• Study Start Date: Sep 1, 2010
• Actual Primary Completion Date: Aug 1, 2012
• Actual Study Completion Date: Aug 1, 2012

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. Exercise Tolerance [Baseline to day 180.]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

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

2. Current ETOH or illicit drug abuse -

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Cincinnati	Cincinnati	Ohio	United States	45267

Sponsors and Collaborators

• Jack Rubinstein
• Forest Laboratories

Investigators

• Principal Investigator: Jack Rubinstein, MD, University of Cincinnati

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jack Rubinstein, Assistant Professor, University of Cincinnati
• ClinicalTrials.gov Identifier: NCT01206439
• Other Study ID Numbers: UC- 09-12-31-04
• First Posted: Sep 21, 2010
• Last Update Posted: Feb 15, 2018
• Last Verified: Feb 1, 2018

• Additional relevant MeSH terms: Hypertension; Nebivolol

Study Results

Participant Flow

Arm/Group Title	Nebivolol 5 or 10 mg, Oral, Daily
Arm/Group Description	Subject will receive either 5 or 10 mg of oral nebivolol daily. Dose will be determined by control of blood pressure. nebivolol: nebivolol 5 or 10 mg oral, daily
Period Title: Overall Study
STARTED	2
COMPLETED	1
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	Nebivolol 5 or 10 mg, Oral, Daily
Arm/Group Description	Subject will receive either 5 or 10 mg of oral nebivolol daily. Dose will be determined by control of blood pressure. nebivolol: nebivolol 5 or 10 mg oral, daily
Overall Participants	1
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	1 100%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	1 100%
Male	0 0%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Insufficient data to analyze.

Arm/Group Title	Nebivolol 5 or 10 mg, Oral, Daily
Arm/Group Description	Subject will receive either 5 or 10 mg of oral nebivolol daily. Dose will be determined by control of blood pressure. nebivolol: nebivolol 5 or 10 mg oral, daily
Measure Participants	0

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Arm/Group Title	Nebivolol 5 or 10 mg, Oral, Daily
Arm/Group Description	Subject will receive either 5 or 10 mg of oral nebivolol daily. Dose will be determined by control of blood pressure. nebivolol: nebivolol 5 or 10 mg oral, daily
All Cause Mortality
	Nebivolol 5 or 10 mg, Oral, Daily
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Nebivolol 5 or 10 mg, Oral, Daily
	Affected / at Risk (%)	# Events
Total	0/1 (0%)
Other (Not Including Serious) Adverse Events
	Nebivolol 5 or 10 mg, Oral, Daily
	Affected / at Risk (%)	# Events
Total	0/1 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.