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

Hypertension Clinical Trial

— EFFORT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00829296
• Other study ID #: 16310B (EFFORT trial)
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: January 26, 2009
• Last updated: January 8, 2016
• Start date: January 2009
• Est. completion date: April 2013

Study information

• Verified date: January 2016
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

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

Other known NCT identifiers

• NCT01059916

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: April 2013
• Est. primary completion date: April 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes
• Hypertension

Intervention

Drug:
• nebivolol
Starting at dose of 5 mg daily titrated up to max of 40 mg until target BP of 130/80 is reached
• Metoprolol
Starting at 50 mg daily dose is titrated to max 200 mg until target BP of 130/80 is reached

Locations

Country	Name	City	State
United States	University of Chicago	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Chicago	Forest Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline and 26 Weeks	No
Secondary	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.	Baseline and 26 Weeks	No
Secondary	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.	Baseline and 26 Weeks	No
Secondary	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).	Baseline and 26 Weeks	No