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

Pre-hypertension Clinical Trial

— DETECT  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00553969
• Other study ID #: 0709M15829
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: November 5, 2007
• Last updated: March 23, 2018
• Start date: November 2007
• Est. completion date: December 2010

Study information

• Verified date: March 2018
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: December 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Pre-hypertension
• Prehypertension

Intervention

Drug:
• 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
• carvedilol phosphate and lisinopril
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
• placebo and placebo
capsule once daily for 9 months; dosage unknown

Locations

Country	Name	City	State
United States	University of Minnesota, Variety Club Research Center 102	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute	GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Disease Score (DS) Among the Treatment Groups	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.	Baseline and nine months