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

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ClinicalTrials.gov Identifier: NCT00829296
Recruitment Status : Completed
First Posted : January 27, 2009
Results First Posted : November 5, 2014
Last Update Posted : February 5, 2016
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
University of Chicago

Brief Summary:
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 or disease Intervention/treatment Phase
Hypertension Diabetes Drug: nebivolol Drug: Metoprolol Phase 2 Phase 3

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effects of Nebivolol on Aortic Impedance Parameters in Type 2 Diabetics
Study Start Date : January 2009
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2013


Arm Intervention/treatment
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
Starting at dose of 5 mg daily titrated up to max of 40 mg until target BP of 130/80 is reached
Other Name: bystolic
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
Starting at 50 mg daily dose is titrated to max 200 mg until target BP of 130/80 is reached
Other Name: lopressor



Primary Outcome Measures :
  1. Change in Central Systolic Blood Pressure (SBP) [ Time Frame: Baseline and 26 Weeks ]
    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 :
  1. Change in Pulse Wave Velocity (PWV) [ Time Frame: Baseline and 26 Weeks ]
    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.

  2. Change in Augmentation Index [ Time Frame: Baseline and 26 Weeks ]
    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.

  3. Change in Pulse Pressure Amplification [ Time Frame: Baseline and 26 Weeks ]
    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).



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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00829296     History of Changes
Obsolete Identifiers: NCT01059916
Other Study ID Numbers: 16310B (EFFORT trial)
First Posted: January 27, 2009    Key Record Dates
Results First Posted: November 5, 2014
Last Update Posted: February 5, 2016
Last Verified: January 2016

Keywords provided by University of Chicago:
diabetes
hypertension
aortic impedance

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Metoprolol
Nebivolol
Anti-Arrhythmia Agents
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Adrenergic beta-1 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists