Conditions: Pre-hypertension
Keywords: cardiovascular disease prevention
Allocation: RANDOMIZED | Intervention model: FACTORIAL
Enrollment: 101
Healthy volunteers: no

Brief summary:
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.

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.

Arms:
arm 1: Coreg CR + lisinopril arm 2: Coreg CR + placebo arm 3: lisinopril + placebo arm 4: placebo + placebo

Interventions: intervention 1: carvedilol phosphate intervention 2: lisinopril intervention 3: carvedilol phosphate and lisinopril intervention 4: placebo and placebo
Intervention descriptions: intervention 1: Extended release capsules, 20mg once daily for 1 month, 40mg once daily for 8 months intervention 2: tablets, 10mg once daily for 1 month, 20mg once daily for 8 months intervention 3: carvedilol phosphate = extended release capsules, 20mg once daily for 1 month, 40mg once daily for 8 months; lisinopril= tablets, 10mg once daily for 1 month, 20mg once daily for 8 months intervention 4: capsule once daily for 9 months; dosage unknown

Protocol document: