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An Advanced Echocardiographic Evaluation of Nebivolol

This study has been terminated.
(Slow enrollment)
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Jack Rubinstein, University of Cincinnati
ClinicalTrials.gov Identifier:
NCT01206439
First received: April 2, 2010
Last updated: October 30, 2012
Last verified: October 2012
  Purpose

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 Intervention Phase
Hypertension
Drug: nebivolol
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Advanced Echocardiographic Evaluation of Nebivolol

Resource links provided by NLM:


Further study details as provided by University of Cincinnati:

Primary Outcome Measures:
  • Change in systolic and diastolic myocardial function [ Time Frame: Baseline to day 180 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Exercise tolerance [ Time Frame: Baseline to day 180. ] [ Designated as safety issue: No ]
    Changes in exercise tolerance and time from baseline to 180 days.


Enrollment: 2
Study Start Date: September 2010
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Bystolic

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.

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 -
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01206439

Locations
United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45267
Sponsors and Collaborators
Jack Rubinstein
Forest Laboratories
Investigators
Principal Investigator: Jack Rubinstein, MD University of Cincinnati
  More Information

No publications provided

Responsible Party: Jack Rubinstein, Assistant Professor, University of Cincinnati
ClinicalTrials.gov Identifier: NCT01206439     History of Changes
Other Study ID Numbers: UC- 09-12-31-04
Study First Received: April 2, 2010
Last Updated: October 30, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hypertension
Cardiovascular Diseases
Vascular Diseases
Nebivolol
Adrenergic Agents
Adrenergic Antagonists
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Antihypertensive Agents
Cardiovascular Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on November 25, 2014