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

The University of Chicago

Status and phase

Completed

Phase 3

Phase 2

Conditions

Hypertension

Diabetes

Treatments

Drug: Metoprolol

Drug: nebivolol

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00829296

16310B (EFFORT trial)

Details and patient eligibility

About

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.

Full description

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

Enrollment

70 patients

Sex

All

Ages

50 to 85 years old

Volunteers

Accepts 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