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

University of Chicago70 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Hypertension Diabetes

Interventions

nebivololDRUG

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

MetoprololDRUG

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

Eligibility

Sex: ALLMin age: 50 YearsMax age: 85 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University of Chicago

Chicago, Illinois, United States

Outcomes

Primary Outcomes

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.

Time frame: Baseline and 26 Weeks

Secondary Outcomes

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.

Time frame: Baseline and 26 Weeks

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.

Time frame: Baseline and 26 Weeks

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).

Time frame: Baseline and 26 Weeks

Data from ClinicalTrials.gov

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