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OpenTrials
Completed

NCT Number: NCT00829296

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

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Vascular Diseases

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

University of Chicago

Chicago, Illinois, 60637, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

nebivolol

Drug

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

metoprolol

Drug

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

Other names: lopressor

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Collaborators

  • Forest Laboratories

Registry information

Official study title

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

Acronym: EFFORT

Important dates

Study start
2009
Primary completion
2012
Study completion
2013
First posted
Jan 27, 2009
Registry last updated
Feb 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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