Efficacy of Coreg CR and Lisinopril on Markers for Cardiovascular Functional and Structural Disease

Condition(s) targeted: Pre-Hypertension

Intervention: carvedilol phosphate (Drug); lisinopril (Drug); carvedilol phosphate and lisinopril (Drug)

Phase: Phase 1/Phase 2

Status: Recruiting

Sponsored by: University of Minnesota

Official(s) and/or principal investigator(s):
Jay N Cohn, MD, Principal Investigator, Affiliation: Professor, University of Minnesota, Cardiology Division

Overall contact:
Sara M Saul, PhD, Phone: 612-626-5446, Email: saul@umn.edu

This study will examine the individual and combined effects of Coreg CR and lisinopril, on cardiovascular health as measured by Rasmussen Disease Score (RDS) in a blinded, placebo controlled comparison over a 9-month study period. Patients to be randomized will have pre-hypertensive blood pressures that do not require anti-hypertensive therapy and at least one additional cardiovascular risk factor.

Official title: Efficacy of Coreg CR and Lisinopril on Markers for Cardiovascular Functional and Structural Disease. DETECT (DEtection and Treatment of Early Cardiovascular Disease Trial)

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Factorial Assignment

Primary outcome: The overall Rasmussen Disease Score (RDS) change from baseline to 9 months will be the primary end-point.

Secondary outcome: Quantitative change in each of the RDS components from baseline to 9 months will serve as a secondary end-point. The 3-month data will provide early evidence for drug efficacy and will be analyzed similarly as a secondary end-point.

Detailed description:

- This study will compare the effect of Coreg CR and lisinopril, separately and together,

on Rasmussen Disease Score in a controlled study with an inactive substance (placebo).

- Study patients will have pre-hypertensive (slightly elevated) blood pressures not

requiring therapy.

- Lisinopril is an angiotensin converting enzyme (ACE) inhibitor. Angiotensin is a

chemical that is made by the body continuously. Angiotensin narrows blood vessels and thereby maintains (elevates) blood pressure. When the enzyme is blocked by lisinopril, angiotensin cannot be converted into its active form. As a result, blood pressure is lowered. Lisinopril is a drug that has been approved for use by the U. S. Food and Drug Administration (FDA) and health authorities for the treatment of high blood pressure and heart failure.

- Coreg CR is a once-a-day heart medication that is part of a class of drugs known as

beta-blockers. Beta-blockers prevent beta-adrenergic substances such as adrenaline from activating parts of the nervous system, including the heart. Beta-blockers therefore relieve stress on the heart by slowing heart beat, decreasing the force of heart muscle contractions, and reducing blood pressure. Coreg has also been approved by the FDA for the treatment of hypertension and various other cardiovascular conditions.

- It is possible that the beta blocker could increase the benefits of the ACE inhibitor by

inhibiting renin production, which is an important step in angiotensin production. These two drugs may act together to provide even more protection to blood vessels and the heart.

Minimum age: 19 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Males and females > 18 years old with pre-hypertensive or borderline blood pressures

(systolic blood pressure ≥ 130 mmHg or diastolic blood pressure ≥ 85 mmHg) deemed not to need antihypertensive therapy. Subjects must also have one additional risk factor for cardiovascular disease, including:

- LDL > 130 and < 160 mg/dL

- HDL < 40 mg/dL

- Fasting blood sugar >100 and < 126 mg/dL

- Body mass index ≥ 30

- Smoker

- Family history of premature heart disease or hypertension

Exclusion Criteria:

- Patients with a history of cardiac, cerebral or other vascular events within the

previous 6 months will be excluded. Other exclusions include background therapy with a beta blocker or ACE inhibitor therapy, known or suspected intolerance to beta blockers or ACE inhibitors, angiotensin receptor blocker therapy, or diabetes. Pregnant or lactating women, and women of child-bearing age who are not using an acceptable form of contraception are also excluded from this study.

Sara M Saul, PhD, Phone: 612-626-5446, Email: saul@umn.edu

University of Minnesota, Variety Club Research Center 102, Minneapolis, Minnesota 55455, United States; Recruiting
Sara M Saul, PhD, Phone: 612-626-5446, Email: saul@umn.edu

Starting date: November 2007
Ending date: September 2009
Last updated: May 22, 2008