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

Primary Purpose

Hypertension, Diabetes

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
nebivolol
Metoprolol
Sponsored by
University of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypertension focused on measuring diabetes, hypertension, aortic impedance

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Chicago

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

nebivolol

Metoprolol

Arm Description

Starting at dose of 5 mg daily titrated up to max of 40 mg until target BP of 130/80 is reached

Starting at 50 mg daily dose is titrated to max 200 mg until target BP of 130/80 is reached

Outcomes

Primary Outcome Measures

Change in Central Systolic Blood Pressure (SBP)
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)
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
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
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).

Full Information

First Posted
January 26, 2009
Last Updated
January 8, 2016
Sponsor
University of Chicago
Collaborators
Forest Laboratories
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1. Study Identification

Unique Protocol Identification Number
NCT00829296
Brief Title
Safety Study to Lower the Risk of Heart Failure is Also Effective in Reducing Stiffness of the Arteries
Acronym
EFFORT
Official Title
The Effects of Nebivolol on Aortic Impedance Parameters in Type 2 Diabetics
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
Collaborators
Forest Laboratories

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Diabetes
Keywords
diabetes, hypertension, aortic impedance

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
nebivolol
Arm Type
Experimental
Arm Description
Starting at dose of 5 mg daily titrated up to max of 40 mg until target BP of 130/80 is reached
Arm Title
Metoprolol
Arm Type
Active Comparator
Arm Description
Starting at 50 mg daily dose is titrated to max 200 mg until target BP of 130/80 is reached
Intervention Type
Drug
Intervention Name(s)
nebivolol
Other Intervention Name(s)
bystolic
Intervention Description
Starting at dose of 5 mg daily titrated up to max of 40 mg until target BP of 130/80 is reached
Intervention Type
Drug
Intervention Name(s)
Metoprolol
Other Intervention Name(s)
lopressor
Intervention Description
Starting at 50 mg daily dose is titrated to max 200 mg until target BP of 130/80 is reached
Primary Outcome Measure Information:
Title
Change in Central Systolic Blood Pressure (SBP)
Description
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.
Time Frame
Baseline and 26 Weeks
Secondary Outcome Measure Information:
Title
Change in Pulse Wave Velocity (PWV)
Description
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.
Time Frame
Baseline and 26 Weeks
Title
Change in Augmentation Index
Description
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.
Time Frame
Baseline and 26 Weeks
Title
Change in Pulse Pressure Amplification
Description
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).
Time Frame
Baseline and 26 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George Bakris, M.D.
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States

12. IPD Sharing Statement

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

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