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

Phase 1

Completed

• Conditions: Pre-hypertension
• Interventions: Drug: carvedilol phosphate and lisinopril; Drug: placebo and placebo; Drug: carvedilol phosphate; Drug: lisinopril

• Registration Number: NCT00553969
• Lead Sponsor: University of Minnesota

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.

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2007-11-05
• Study First Submitted QC: 2007-11-05
• Study First Posted: 2007-11-06
• Primary Completion: 2010-09
• Study Completion: 2010-12
• Results First Submitted: 2013-12-16
• Results First Submitted QC: 2014-12-09
• Results First Posted: 2014-12-17
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-23
• Last Update Posted: 2018-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
1	carvedilol phosphate and lisinopril	Coreg CR + lisinopril
4	placebo and placebo	placebo + placebo
2	carvedilol phosphate	Coreg CR + placebo
3	lisinopril	lisinopril + placebo

Primary Outcome Measures

Name	Time	Method
Change in Disease Score (DS) Among the Treatment Groups	Baseline and nine months	Rasmussen Disease Score (RDS) Change From Baseline to 9 Months A score of six or higher on these tests means the patient likely has plaque build-up in the arteries, or atherosclerosis, while a score of three to five suggests that such a problem may be developing. A score of two or less signals a patient is fine but should return in the future for another test. The method detects disease at the earliest moment, before the traditionally used calcium score would show any signs of trouble.

Trial Locations

Locations (1)

University of Minnesota, Variety Club Research Center 102; 🇺🇸 Minneapolis, Minnesota, United States