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

Phase 2

Completed

• Conditions: Hypertension; Diabetes
• Interventions: Drug: nebivolol; Drug: Metoprolol

• Registration Number: NCT00829296
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-01-26
• Study First Submitted QC: 2009-01-26
• Study First Posted: 2009-01-27
• Primary Completion: 2012-04
• Study Completion: 2013-04
• Results First Submitted: 2014-08-04
• Results First Submitted QC: 2014-10-29
• Results First Posted: 2014-11-05
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-08
• Last Update Posted: 2016-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Change in Central Systolic Blood Pressure (SBP)	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

Name	Time	Method
Change in Pulse Pressure Amplification	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).
Change in Pulse Wave Velocity (PWV)	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.
Change in Augmentation Index	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.

Trial Locations

Locations (1)

University of Chicago; 🇺🇸 Chicago, Illinois, United States