Design and Statistical Aspects of the African American Study of Kidney Disease and Hypertension (AASK)
Key result
The AASK trial is designed to evaluate the effectiveness of three anti-hypertensive drug regimens and two levels of blood pressure control on the progression of hypertensive kidney disease.
Why the study?
Do specific anti-hypertensive drug regimens (ramipril, amlodipine, metoprolol) and lower blood pressure goals improve the rate of change in renal function in African-Americans with hypertensive kidney disease?
Population
African-American men and women aged 18 to 70 yr who have hypertensive kidney disease and GFR between 20 and…
Comparison
Three anti-hypertensive drug regimens as initial… vs Comparison between the three drug regimens and…
Design
Other, randomized
Authors
Discussion
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Implication
Addresses optimal antihypertensive strategies for hypertensive kidney disease in African-Americans; leaves open definitive renal outcomes.
Key Points
- To outline the rationale, design, and statistical methods evaluating three antihypertensive drug regimens and two blood pressure goals on renal disease progression.
- Multicenter randomized clinical trial enrolling African American men and women aged 18 to 70 years with hypertensive kidney disease and baseline GFR between 20 and 65 ml/min per 1.73 m².
- Participants were randomized to three initial drug therapies (ramipril, amlodipine, or metoprolol) and two blood pressure targets (mean arterial pressure ≤92 mmHg versus 102–107 mmHg).
- The primary outcome was GFR slope measured via 125I-iothalamate clearance, with a secondary composite of 50% GFR reduction, end-stage renal disease, or death.
- Comparative efficacy outcomes and event rates were not reported in this baseline protocol and trial design publication.
- Established protocol parameters for testing whether intensive blood pressure reduction and specific drug classes slow renal deterioration relative to standard care.
Study Design
Type
RCT
Randomization
Randomized
Multicenter
Yes
Structured PICO
Do specific anti-hypertensive drug regimens (ramipril, amlodipine, metoprolol) and lower blood pressure goals improve the rate of change in renal function in African-Americans with hypertensive kidney disease?
P
Population
African-American men and women aged 18 to 70 yr who have hypertensive kidney disease and GFR between 20 and 65 ml/min per 1.73 m(2)
I
Intervention
Three anti-hypertensive drug regimens (ramipril, amlodipine, or metoprolol) as initial therapy, and two levels of BP control (lower goal: mean arterial pressure ≤92 mmHg, usual goal: mean arterial pressure 102 to 107 mmHg)
C
Comparator
Comparison between the three drug regimens and the two BP control goals
O
Outcome
Rate of change in renal function as measured by GFR, assessed by (125) I-iothalamate clearancesurrogate
The AASK trial is designed to evaluate the optimal anti-hypertensive regimen and blood pressure target for slowing the progression of hypertensive kidney disease in African-Americans.
Cite This Study
Gassman et al. (2003) conducted an RCT in Hypertensive kidney disease. Ramipril, amlodipine, or metoprolol; lower BP goal (MAP ≤92 mmHg) vs usual BP goal (MAP 102-107 mmHg) vs. Active comparators and different BP goals was evaluated on Rate of change in renal function as measured by GFR, assessed by (125) I-iothalamate clearance. The AASK trial is designed to evaluate the effectiveness of three anti-hypertensive drug regimens and two levels of blood pressure control on the progression of hypertensive kidney disease.