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

This study has been completed.
Forest Laboratories
Information provided by (Responsible Party):
University of Chicago Identifier:
First received: January 26, 2009
Last updated: October 29, 2014
Last verified: October 2014
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
Hypertensive Diabetes
Drug: nebivolol
Drug: Metoprolol
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effects of Nebivolol on Aortic Impedance Parameters in Type 2 Diabetics

Resource links provided by NLM:

Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • Change in Central Systolic Blood Pressure (SBP) [ Time Frame: Baseline and 26 Weeks ] [ Designated as safety issue: No ]
    Changes in aortic impedance in patients on nebivolol vs. metoprolol succinate in Type 2 hypertensive diabetic patients as measured by the change from baseline in central systolic blood pressure.

Secondary Outcome Measures:
  • Change in Pulse Wave Velocity (PWV) [ Time Frame: Baseline and 26 Weeks ] [ Designated as safety issue: No ]
    To examine the effect of nebivolol versus metoprolol succinate in Type 2 hypertensive diabetic patients on other measures of central conduit artery function such as pulse wave velocity.

  • Change in Augmentation Index [ Time Frame: Baseline and 26 Weeks ] [ Designated as safety issue: No ]
    Augmentation index is defined as the percentage of the central pulse pressure which is attributed to the reflected pulse wave and, therefore, reflects the degree to which central arterial pressure is augmented by wave reflection.

  • Change in Pulse Pressure Amplification [ Time Frame: Baseline and 26 Weeks ] [ Designated as safety issue: No ]
    To examine the effect of nebivolol versus metoprolol succinate in Type 2 hypertensive diabetic patients on other measures of central conduit artery function such as pulse pressure amplification (central pulse pressure /brachial pulse pressure).

Enrollment: 70
Study Start Date: January 2009
Study Completion Date: April 2013
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: nebivolol
Starting at dose of 5 mg daily titrated up to max of 40 mg until target BP of 130/80 is reached
Drug: nebivolol
Active Comparator: Metoprolol
Starting at 50 mg daily dose is titrated to max 200 mg until target BP of 130/80 is reached
Drug: Metoprolol

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
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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
Results First Received: August 4, 2014
Last Updated: October 29, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Chicago:
aortic impedance

Additional relevant MeSH terms:
Adrenergic Agents
Adrenergic Antagonists
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Anti-Arrhythmia Agents
Antihypertensive Agents
Autonomic Agents
Cardiovascular Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Vasodilator Agents processed this record on November 24, 2015