Hypertension
Conditions
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.
Interventions
DRUGCarvedilol CR
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
DRUGAtenolol
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
Sponsors
University of Florida
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Central Aortic Blood Pressure | Measured at baseline and 4 weeks. |
Secondary
| Measure | Time frame |
|---|---|
| Peripheral Blood Pressure | Measured at baseline, 2 weeks, and 4 weeks. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Carvedilol CR Controlled-release carvedilol 20 mg - Forced titration occurred in carvedilol to 40 mg at week one, and to 80 mg at week two. | 22 |
| Atenolol Atenolol 25 mg once daily - Forced titration occurred in atenolol to 50 mg at week one, and to 100 mg at week two. | 19 |
| Total | 41 |
Baseline characteristics
| Characteristic | Atenolol | Carvedilol CR | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 19 Participants | 22 Participants | 41 Participants |
| Age, Continuous | 46.1 years STANDARD_DEVIATION 9.9 | 47.7 years STANDARD_DEVIATION 13.1 | 46.9 years STANDARD_DEVIATION 11.5 |
| Region of Enrollment United States | 19 participants | 22 participants | 41 participants |
| Sex: Female, Male Female | 13 Participants | 13 Participants | 26 Participants |
| Sex: Female, Male Male | 6 Participants | 9 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 22 | 0 / 19 |
| serious Total, serious adverse events | 0 / 22 | 0 / 19 |
Outcome results
Primary
Central Aortic Blood Pressure
Time frame: Measured at baseline and 4 weeks.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Carvedilol CR | Central Aortic Blood Pressure | -16.1 mmHg | Standard Error 10.4 |
| Atenolol | Central Aortic Blood Pressure | -16.0 mmHg | Standard Error 18.7 |
Secondary
Peripheral Blood Pressure
Time frame: Measured at baseline, 2 weeks, and 4 weeks.