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.
Forest Laboratories
Information provided by (Responsible Party):
University of Chicago Identifier:
First received: January 26, 2009
Last updated: September 6, 2013
Last verified: January 2013

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:

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
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.


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

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 identifier: NCT00829296

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

No publications provided

Responsible Party: University of Chicago Identifier: NCT00829296     History of Changes
Obsolete Identifiers: NCT01059916
Other Study ID Numbers: 16310B (EFFORT trial)
Study First Received: January 26, 2009
Last Updated: September 6, 2013
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
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 processed this record on April 23, 2014