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Citation
Gassman, Jennifer (2020). African American Study of Kidney Disease and Hypertension Study (Clinical Trial) (AASK Trial) (Version 8) [Dataset] NIDDK Central Repository. https://doi.org/10.58020/jtkq-h450
Data Availability Statement
Data from the African American Study of Kidney Disease and Hypertension Study (Clinical Trial) (AASK Trial) [(Version 8) https://doi.org/10.58020/jtkq-h450] reported here are available for request at the NIDDK Central Repository (NIDDK-CR) website, Resources for Research (R4R), https://repository.niddk.nih.gov/.
Acknowledgement Statement
The AASK Trial study was conducted by the study investigators and supported by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The resources from the AASK Trial (https://doi.org/10.58020/jtkq-h450) study reported here were supplied by NIDDK Central Repository (NIDDK-CR) and are available for request at https://repository.niddk.nih.gov. This manuscript was not prepared under the auspices of the AASK Trial study and does not necessarily reflect the opinions or views of the AASK Trial study, NIDDK-CR, or NIDDK.
Data Package Version
Version 8 (Updated on: Nov 18, 2020)
Resource Availability
  • Data Available for Request
  • Specimens Available for Request
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General Description

The African American Study of Kidney Disease and Hypertension study (AASK Trial) was a multi-center, randomized clinical trial that investigated the effects of blood pressure (BP) control and the use of specific antihypertensive regimens on the progression of chronic kidney disease (CKD). The study was designed to address the high incidence of CKD in African Americans with hypertension. A two by three factorial study design, including two levels of BP control as defined by mean arterial pressure (MAP) and three different anti-hypertensive regimens, was used. Participants were randomized into two levels of BP control groups, either a goal MAP < 92 mmHg or a goal MAP between 102-107 mmHg inclusive.. The antihypertensive drugs used for treatment were amlodipine, a calcium channel blocker; ramipril, an angiotensin-converting enzyme inhibitor; and metoprolol, a β-blocker. The trial was double-blind (drug administration only). The change in glomerular filtration rate (GFR) as determined by iothalamate clearance was measured as the primary outcome to test the regimens’ efficacy in slowing the rate of decline of kidney function.

The study showed that the angiotensin-converting enzyme inhibitor ramipril was more effective than the beta blocker metoprolol or the dihydropyridine calcium channel blocker amlodipine in slowing the rate of GFR decline. The results suggest that reduction in blood pressure to levels below those currently advocated for cardiovascular risk reduction does not provide readily identifiable benefits to African Americans with hypertensive nephrosclerosis.

Objectives

The AASK study aimed to determine the effects of a lower than usual level of blood pressure control and the use of specific antihypertensive regimens on the progression of renal insufficiency that was clinically attributed to the effects of hypertension on the kidney. Two levels of BP control and 3 different antihypertensive regimens were tested for efficacy in slowing the rate of decline of renal function.

Outcome Measure

The primary outcome measure was change in GFR as determined by iothalamate clearance. Secondary outcome measures included a time-to-event analysis of reduction in GFR by 50% or by 25 ml/min/1.73m2, end-stage renal disease (ESRD), and death to determine the clinical impact of the interventions.

Eligibility Criteria

The study enrolled African-American men and women between 18 and 70 years of age who presented with hypertension (defined as a sitting diastolic blood pressure of 95 mmHg or more) and reduced renal function (defined as a pre-randomization 125I-iothalamate glomerular filtration rate between 20 65 ml/min/1.73m2).

Exclusion criteria are documented in the study protocol.

Outcome

Results of the AASK study showed that the angiotensin-converting enzyme inhibitor ramipril was was more effective than the beta blocker metoprolol or the dihydropyridine calcium channel blocker amlodipine in slowing the rate of glomerular filtration rate decline in African American patients with mild to moderate renal insufficiency. Notably, there was no significant difference in the rate of decline in kidney function between the 92 mmHg or less and the 102-107 mmHg MAP groups. The study suggests that reduction in blood pressure to levels below those currently advocated for cardiovascular risk reduction does not provide readily identifiable benefits to African Americans with hypertensive nephrosclerosis. While this study provides the basis for the primary use of angiotensin-converting enzyme inhibitors in an African American population, it is undetermined if this represents a class effect for all angiotensin-converting enzyme inhibitors.

Research Area

Multidisciplinary Research, Kidney Disease

Study Type

Interventional

Study Sites

21

Study Start Date

1995-02

Study End Date

2007-06

Condition

Cardiovascular Disorder, Chronic Kidney Disease, Hypertensive Disorder

Keywords

Glomerular Filtration Rate (GFR), Hypertension, Blood Pressure Control, Renal Insufficiency, MAP, Drug Therapy, Mean Arterial Pressure, Cardiovascular Disease, Chronic Kidney Disease (CKD), Kidney Disease

NIDDK Division

Division of Kidney, Urologic, and Hematologic Diseases

3,017
Participants

Target Population
Adults

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Buffy Coat852
DNA7941
Serum17760
Urine12896