African American Study of Kidney Disease and Hypertension ABPM Pilot Study

4. Methods 4a. Overview The study will be conducted in participants in the African-American Study of Kidney Disease (AASK) Cohort study as a randomized three period cross-over trial.

Eighty five percent of AASK cohort participants are currently on an ACE inhibitor or angiotensin receptor blocker; the most commonly used ACE inhibitor is ramipril. The new strategies proposed in this pilot study will remain ramipril-based, to maintain the overall blood pressure control achieved thus far.

The antihypertensive regimens proposed are as follows:

* AM dosing of ramipril and other once daily medications in the participants antihypertensive regimen (termed USUAL), * Bedtime dosing of ramipril and other once a day medications in the participant's antihypertensive regimen (termed HS-DOSING), and * their current antihypertensive regimen plus an additional antihypertensive agent dosed at bed time; the choice of the additional agent will be tailored based on prespecified clinical guidelines (termed ADD-ON DOSING)

The "usual arm" serves as the comparator arm. The "hs dosing" and "add-on dosing" arms test practical strategies that could be tested in a subsequent clinical outcomes trial and that could be implemented in clinical practice. We hypothesize that both arms will reduce nocturnal BP in comparison to "usual dosing". We further hypothesize that the "hs dosing" arm will raise daytime BP somewhat but have no net effect on 24 hour BP and that the "add on dosing" arm will have no effect on daytime BP but lower 24 hour BP.

This pilot study will begin after the last scheduled AASK Cohort study visit. Eligible participants will be treated for 6 weeks on each of 3 antihypertensive regimens. The sequence of the regimens will be random. Each period of the three periods will have 2 visits, one visit at 3 weeks and one visit at 6 weeks. In the last week of each 6-week period, a 24-hour ABPM will be obtained. The primary outcome variable is nocturnal BP; each pair wise difference between the regimens will be calculated.

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Key information

Conditions

Hypertensive Renal Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hypertensive Nephropathy Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

University of Alabama, Birmingham, Alabama, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Participant in the AASK Cohort Study
Ability and willingness to provide informed consent
Completion of a technically adequate ABPM at CO48 AASK cohort study visit.
Participants must have had at least 2 visits in the last 12 months of the Cohort Study (July 1 2006 to June 1 2007)
The average of last two BPs measured at least one week apart in the Cohort Study must be less than or equal to 140/90 mm Hg. This would exclude a small percentage of the AASK cohort population; however, it would enroll a group of participants with stable BP who should not require adjustments to their antihypertensive medications during the course of this study.
Antihypertensive medications at baseline visit: This refers to the participant's antihypertensive regimen at the time of the baseline visit ; the transition period may be used to adjust the participant's antihypertensive regimen to meet these criteria, based on the clinical judgement of the site investigator.

Exclusion criteria

Arm circumference greater than 50 cms.
ESRD requiring renal replacement therapy or kidney transplantation
Institutionalized participants
Shift workers working at night
MI or CVA within 3 months of AASK Cohort close out visit
Participants with known ejection fraction less than 40%
Females known to be pregnant or lactating
Participants likely to reach end stage renal disease within the next six weeks, in the judgement of the site investigator

Treatment and study plan

USUAL - take your BP Meds as you usually do

Behavioral

The patient's antihypertensive regimen at the baseline visit is the comparison (or control) regimen. All once a day medications will be administered in the morning.

HS DOSING

Behavioral

Take your usual BP meds at bed time

ADD On Dosing

Drug

Take your usual BP meds but add one more med at bed time.

Primary outcomes

Night Time Blood Pressure

Time frame: Night time blood pressure from APBM at weeks 6, 12, and 18

Secondary outcomes

Blood pressure in the clinic Daytime blood pressure

Time frame: Measured at weeks 6, 12, and 18

Sponsors and collaborators

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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Registry information

Important dates

Study start: 2007
Primary completion: 2008
Study completion: 2008
First posted: Dec 28, 2007
Registry last updated: Apr 16, 2012

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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