Clinical trial NCT00669279: Effect of Carvedilol Controlled-Release (CR) and Atenolol on Central Blood Pressure
Official title: Non-Invasive Determination of Central Aortic Blood Pressure in Hypertensive Patients Treated With Controlled-Release Carvedilol or Atenolol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2008-04-30
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Central Aortic Blood Pressure
timeFrame: Measured at baseline and 4 weeks.
Secondary outcomes:
measure: Peripheral Blood Pressure
timeFrame: Measured at baseline, 2 weeks, and 4 weeks.
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Benjamin Epstein, Pharm.D.
role: PRINCIPAL_INVESTIGATOR
References: