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

January 8, 2016 updated by: University of Chicago

The Effects of Nebivolol on Aortic Impedance Parameters in Type 2 Diabetics

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

70

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • lopressor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and 26 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and 26 Weeks
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.
Baseline and 26 Weeks
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).
Baseline and 26 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chicago

Collaborators

Forest Laboratories

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

January 26, 2009

First Submitted That Met QC Criteria

January 26, 2009

First Posted (Estimate)

January 27, 2009

Study Record Updates

Last Update Posted (Estimate)

February 5, 2016

Last Update Submitted That Met QC Criteria

January 8, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16310B (EFFORT trial)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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