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Safety Study to Lower the Risk of Heart Failure is Also Effective in Reducing Stiffness of the Arteries (EFFORT)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
George L Bakris, MD, University of Chicago
ClinicalTrials.gov Identifier:
NCT00829296
First received: January 26, 2009
Last updated: January 22, 2013
Last verified: January 2013
History of Changes
  Purpose

The study is being done to see if a drug shown to lower the risk of heart failure is also effective in reducing the stiffness of the arteries.


Condition Intervention Phase
Stiffness of the Arteries
 Drug: nebivolol
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: The Effects of Nebivolol on Aortic Impendance Parameters in Type 2 Diabetics

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • It is thought that reducing the stiffness of arteries may provide an additional benefit in reducing the risk of death. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: January 2009
Estimated Study Completion Date: December 2013
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: nebivolol
bystolic
 Drug: nebivolol
taken once daily
Other Name: bystolic

Detailed Description:

To determine the effect of nebivolol versus metoprolol in Type 2 hypertensive diabetic patients on systolic blood pressure and diastolic blood pressure.

  Eligibility

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Established Type 2 diabetic not treated with insulin
  • Stage 1 hypertensives blood pressure > 130/80 mmHg and < 160/100 mmHg
  • BMI < 35
  • Hemoglobin A1C < 8.5
  • Must be postmenopausal or taking some form of birth control of surgically sterile

Exclusion Criteria:

  • Acute myocardial infarction, unstable angina, stroke or TIA within the past year.
  • Active angina in the last three months
  • Diabetes requiring treatment with insulin
  • Severe asthma
  • Female who are pregnant, planning to be pregnant during the study period, lactating or women of childbearing potential who are not using a medically approved method of contraception
  • Recent history of substance or alcohol abuse .
  • Uncontrolled hypertension systolic blood pressure >160mmHg or diastolic blood pressure > 100 mmHg
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00829296

Locations
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Forest Laboratories
Investigators
Principal Investigator: George Bakris, M.D. University of Chicago
  More Information

No publications provided

Responsible Party: George L Bakris, MD, Principal Investigator, University of Chicago
ClinicalTrials.gov Identifier: NCT00829296     History of Changes
Obsolete Identifiers: NCT01059916
Other Study ID Numbers: 16310B (EFFORT trial)
Study First Received: January 26, 2009
Last Updated: January 22, 2013
Health Authority: United States: Institutional Review Board
USA: FDA

Keywords provided by University of Chicago:
reducing stiffness of the arteries

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

ClinicalTrials.gov processed this record on June 18, 2013