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NCT Number: NCT00669279

Effect of Carvedilol Controlled-Release (CR) and Atenolol on Central Blood Pressure

The purpose of this research study is to determine whether atenolol or controlled release carvedilol lower blood pressure in the body as effectively as in the arm. Blood pressure measured in the aorta, a large blood vessel carrying blood away from the heart, may be a better measure of the harmful effects of high blood pressure on the body's organs. In the past, blood pressure has only been measured in the arms. However, blood pressure in the arms may not accurately reflect the blood pressure in the aorta and thus may mislead doctors treating high blood pressure. For this reason, we are testing whether two different medications for blood pressure, both in a class called beta blockers, have similar effects on blood pressure in the arm and aorta.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Florida

Gainesville, Florida, 32610, United States

About this study

Carvedilol reduces aortic wave reflection and improves left ventricular/vascular coupling: a comparison with atenolol (CENTRAL Study) is a prospective, open-label, comparative, randomized control trial that evaluated brachial and central hemodynamic profiles in patients taking atenolol or controlled-release carvedilol.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • At least 18 years of age
  • Hypertension (untreated or treated with no more then one anti-hypertensive drug)

Exclusion criteria

  • Secondary forms of hypertension (including sleep apnea)
  • Patients currently treated with two or more antihypertensive drugs
  • Patients taking antihypertensive drugs with properly measured clinic systolic blood pressure greater then 170mmHg
  • Isolated systolic hypertension
  • Other diseases requiring treatment with blood pressure lowering medications
  • Heart rate less then 55 beats/min (in the absence of beta-blocker therapy)
  • Known cardiovascular disease including history of angina pectoris, heart failure, presence of a cardiac pacemaker, history of myocardial infarction or revascularization procedure, or cerebrovascular disease (including stroke and TIA)
  • Known diabetes mellitus (Type 1 or 2)
  • Renal insufficiency defined as a serum creatinine greater then 1.5mg/dL in males and 1.4mg/dL in females
  • Primary renal disease
  • Pregnancy or lactation
  • History of Raynaud's syndrome
  • Alcoholism and recreational drug use (due to compliance concerns)

Treatment and study plan

Carvedilol CR

Drug

Dose titration of 20mg by mouth once daily for 1 week, then 40mg by mouth once daily for 1 week, then 80mg by mouth once daily for 2 weeks

Other names: Coreg CR

Atenolol

Drug

Dose titration of 25mg by mouth once daily for 1 week, then 50mg by mouth once daily for 1 week, then 100mg by mouth once daily for 2 weeks

Other names: Tenormin

Primary outcomes

  1. Central Aortic Blood Pressure

    Time frame: Measured at baseline and 4 weeks.

Secondary outcomes

  1. Peripheral Blood Pressure

    Time frame: Measured at baseline, 2 weeks, and 4 weeks.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • GlaxoSmithKline

Registry information

Official study title

Non-Invasive Determination of Central Aortic Blood Pressure in Hypertensive Patients Treated With Controlled-Release Carvedilol or Atenolol

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Apr 30, 2008
Registry last updated
Oct 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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