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

University of Minnesota (UMN)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Pre-hypertension

Treatments: Drug: carvedilol phosphate; Drug: lisinopril; Drug: carvedilol phosphate and lisinopril; Drug: placebo and placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00553969

0709M15829

Details and patient eligibility

About

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.

Full 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.

Enrollment: 101 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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101 participants in 4 patient groups, including a placebo group

1

Experimental group

Description:

Coreg CR + lisinopril

Treatment:

Drug: carvedilol phosphate and lisinopril

2

Experimental group

Description:

Coreg CR + placebo

Treatment:

Drug: carvedilol phosphate

3

Experimental group

Description:

lisinopril + placebo

Treatment:

Drug: lisinopril

4

Placebo Comparator group

Description:

placebo + placebo

Treatment:

Drug: placebo and placebo