Trial Outcomes & Findings for A Pilot Study of Chlorthalidone Among Patients With Poorly Controlled Hypertension and CKD (NCT NCT01750294)

NCT ID: NCT01750294

Last Updated: 2016-06-13

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 14 participants
• Primary outcome timeframe: Baseline and 12 weeks after intervention
• Results posted on: 2016-06-13

Participant Flow

Subjects were recruited from the VA Medical Center from Sept. 18, 2012 - May 15, 2013. Eligible subjects were ≥ 18 years of age with estimated glomerular filtration rate ≤ 45 but > 20 mL/min/1.73m2. The study initially recruited subjects with resistant hypertension but was amended to include those with poorly controlled but treated hypertension.

Prior to assignment, participants completed home blood pressure monitoring, ambulatory blood pressure monitoring, and a two-week run-in period, during which all subjects received a standard anti-hypertensive regimen based on the existing regimen of the subject.

Participant milestones

Measure	Chlorthalidone Open-label, forced-titration of Chlorthalidone (25mg/day at baseline)
Overall Study STARTED	14
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	Chlorthalidone Open-label, forced-titration of Chlorthalidone (25mg/day at baseline)
Overall Study Withdrawal by Subject	1
Overall Study Safety Endpoint	1

Baseline Characteristics

A Pilot Study of Chlorthalidone Among Patients With Poorly Controlled Hypertension and CKD

Baseline characteristics by cohort

Measure	Chlorthalidone n=14 Participants Open-label, forced-titration of Chlorthalidone (25mg/day at baseline)
Age, Continuous	67.5 years STANDARD_DEVIATION 10.2 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	8 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Chronic Kidney Disease (CKD) Stage Stage 3B	4 participants n=5 Participants
Chronic Kidney Disease (CKD) Stage Stage 4	8 participants n=5 Participants
Chronic Kidney Disease (CKD) Stage Stage 5	2 participants n=5 Participants
Estimated GFR	26.8 mL/min/1.73m2 STANDARD_DEVIATION 8.8 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 12 weeks after intervention

Population: Intention to treat analysis (includes completers and non-completers)

Outcome measures

Measure	Chlorthalidone n=14 Participants Open-label, forced-titration of Chlorthalidone (25mg/day at baseline)
Change of Systolic Ambulatory Blood Pressure From Baseline to 12 Weeks	-10.5 mmHg Standard Deviation 4.2

Adverse Events

Chlorthalidone

Serious events: 2 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Measure	Chlorthalidone n=14 participants at risk Open-label, forced-titration of Chlorthalidone (25mg/day at baseline)
Renal and urinary disorders Elective kidney biopsy	7.1% 1/14 • Number of events 1 • Baseline (week 0) through study completion (week 12)
Nervous system disorders New-onset ischemic stroke	7.1% 1/14 • Number of events 1 • Baseline (week 0) through study completion (week 12)
Vascular disorders Hypotension	7.1% 1/14 • Number of events 2 • Baseline (week 0) through study completion (week 12)
Nervous system disorders Syncope	7.1% 1/14 • Number of events 2 • Baseline (week 0) through study completion (week 12)

Other adverse events

Measure	Chlorthalidone n=14 participants at risk Open-label, forced-titration of Chlorthalidone (25mg/day at baseline)
Metabolism and nutrition disorders Hypokalemia	28.6% 4/14 • Number of events 4 • Baseline (week 0) through study completion (week 12)
Metabolism and nutrition disorders Hyperuricemia	28.6% 4/14 • Number of events 4 • Baseline (week 0) through study completion (week 12)
Metabolism and nutrition disorders Hyponatremia	21.4% 3/14 • Number of events 3 • Baseline (week 0) through study completion (week 12)
Investigations Transient elevations of serum creatinine	21.4% 3/14 • Number of events 3 • Baseline (week 0) through study completion (week 12)
Nervous system disorders Dizziness	7.1% 1/14 • Number of events 1 • Baseline (week 0) through study completion (week 12)
Metabolism and nutrition disorders Hyperglycemia	7.1% 1/14 • Number of events 1 • Baseline (week 0) through study completion (week 12)
Gastrointestinal disorders Constipation	7.1% 1/14 • Number of events 1 • Baseline (week 0) through study completion (week 12)

Additional Information

Rajiv Agarwal, MD, FAHA, FASN, FASH

Indiana University & Richard L Roudebush VA Medical Center

Phone: 317-988-2241

Email: ragarwal@iu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place