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

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

This study is ongoing, but not recruiting participants.

First Received: January 26, 2009 Last Updated: January 27, 2009 History of Changes

Sponsors and Collaborators:	University of Chicago Forest Laboratories
Information provided by:	University of Chicago
ClinicalTrials.gov Identifier:	NCT00829296

Purpose

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.

Condition	Intervention	Phase
Stiffness of the Arteries	Drug: nebivolol	Phase II Phase III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind (Subject), Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	The Effects of Nebivolol on Aortic Impendance Parameters in Type 2 Diabetics

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure

Drug Information available for: Nebivolol

U.S. FDA Resources

Further study details as provided by University of Chicago:

Primary Outcome Measures:

It is thought that reducing the stiffness of arteries may provide an additional benefit in reducing the risk of death. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	60
Study Start Date:	January 2009
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
nebivolol: Experimental bystolic	Drug: nebivolol taken once daily

Detailed Description:

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

Eligibility

Ages Eligible for Study:	50 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00829296

Locations

United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
University of Chicago
Chicago, Illinois, United States, 60637

Sponsors and Collaborators

University of Chicago

Forest Laboratories

Investigators

Principal Investigator:

George Bakris, M.D.

University of Chicago

More Information

No publications provided

Responsible Party:	University of Chicago ( George Bakris, M.D. Principal Investigator )
Study ID Numbers:	16310B (EFFORT trial)
Study First Received:	January 26, 2009
Last Updated:	January 27, 2009
ClinicalTrials.gov Identifier:	NCT00829296 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Chicago:

reducing stiffness of the arteries

Study placed in the following topic categories:

Neurotransmitter Agents
Vasodilator Agents
Heart Failure
Adrenergic Agents
Adrenergic beta-Antagonists

Nebivolol
Adrenergic Antagonists
Cardiovascular Agents
Antihypertensive Agents

Additional relevant MeSH terms:

Neurotransmitter Agents
Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Therapeutic Uses
Physiological Effects of Drugs

Adrenergic beta-Antagonists
Nebivolol
Adrenergic Antagonists
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 10, 2009