A Phase 4 interventional study of Spironolactone in Resistant Hypertension, Kidney Failure, Chronic and Hemodialysis, sponsored by Universitas Sebelas Maret. Completed at 1 site in Indonesia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by Universitas Sebelas Maret · Phase 4, Interventional, and Treatment
Many patients on hemodialysis have high blood pressure that does not respond to three or more drugs (resistant hypertension). This pilot study gave a low dose of spironolactone (12.5 mg once daily) for 6 weeks to adults on hemodialysis with resistant hypertension. The study measured changes in blood pressure, heart rate variability, markers of inflammation (interleukin-6 and high-sensitivity C-reactive protein), a marker of cardiac stress (NT-proBNP), and serum potassium.
Design: single-center, open-label, single-arm pilot study with a pre-test and post-test design.
Setting: Kidney-Hypertension Clinic and Hemodialysis Unit, Dr. Moewardi General Hospital, Surakarta, Central Java, Indonesia.
Participants: adults with stage 5 chronic kidney disease on hemodialysis twice weekly, with resistant hypertension despite three antihypertensive drug classes including a diuretic.
Intervention: oral spironolactone 12.5 mg once daily for 6 weeks, added to the existing antihypertensive regimen.
Measurements at baseline and week 6: office blood pressure; short-term heart rate variability recorded with a finger photoplethysmography HRV analyzer (SDNN, RMSSD, total power, VLF, LF, HF, LF/HF ratio); serum interleukin-6, high-sensitivity C-reactive protein, and NT-proBNP; serum potassium, urea, and creatinine.
Analysis: baseline and week-6 values were compared with the paired t-test or the Wilcoxon signed-rank test.
Sample size: 21 participants (Slovin's formula, minimum 19, plus 10% for dropout).
Ethics: approved by the Health Research Ethics Committee of Dr. Moewardi General Hospital (No. 1.779/VIII/HREC/2024, No. 2.071/VIII/HREC/2024, and No. 2.255/IX/HREC/2024).
Registration note: this study was registered retrospectively after completion.
2,121 studies on the registry are indexed under Kidney Failure, Chronic; 264 are open to participants now.
This study's enrollment of 21 is below the median of 55 across 1,582 interventional studies indexed under Kidney Failure, Chronic.
Browse Kidney Failure, Chronic studies →Universitas Sebelas Maret is the lead sponsor of 28 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Oral spironolactone 12.5 mg once daily for 6 weeks, added to the existing antihypertensive regimen.
Drug: Spironolactone
Spironolactone 12.5 mg taken orally once daily for 6 weeks.
Change in systolic blood pressure
Office systolic blood pressure (mmHg). Change = week-6 value minus baseline value.
Time frame: Baseline and week 6
Change in diastolic blood pressure
Office diastolic blood pressure (mmHg). Change = week-6 value minus baseline value.
Time frame: Baseline and week 6
Change in SDNN
Standard deviation of normal-to-normal intervals (ms) from short-term heart rate variability recording. Change = week-6 value minus baseline value.
Time frame: Baseline and week 6
Change in RMSSD
Root mean square of successive differences (ms) from short-term heart rate variability recording. Change = week-6 value minus baseline value.
Time frame: Baseline and week 6
Change in frequency-domain heart rate variability
Total power, very-low-frequency power, low-frequency power, high-frequency power (ms\^2), and LF/HF ratio. Change = week-6 value minus baseline value.
Time frame: Baseline and week 6
Change in serum interleukin-6
Serum interleukin-6 (pg/mL) measured by ELISA. Change = week-6 value minus baseline value.
Time frame: Baseline and week 6
Change in serum high-sensitivity C-reactive protein
Serum hs-CRP (mg/L) measured by particle-enhanced immunoturbidimetric assay. Change = week-6 value minus baseline value.
Time frame: Baseline and week 6
Change in serum NT-proBNP
Serum N-terminal pro-B-type natriuretic peptide (pg/mL) measured by ELISA. Change = week-6 value minus baseline value.
Time frame: Baseline and week 6
Change in serum potassium
Serum potassium (mmol/L), the main safety measure. Change = week-6 value minus baseline value.
Time frame: Baseline and week 6
Change in serum urea and creatinine
Serum urea and creatinine (mg/dL). Change = week-6 value minus baseline value.
Time frame: Baseline and week 6
Plan to share: No — Individual participant data will not be posted publicly. De-identified data are available from the study team on reasonable request.
No publications or documents are linked to this record.
Ran from Aug 2024 to primary completion in Oct 2024, 2 months.
Of 54 non-industry phase 4 interventional studies under Kidney Failure, Chronic, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 67. This study's 2 months is below that.
Counting every sponsor, half of 64 studies reached it within 31 months; a quarter within 16 and three quarters within 51.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Spironolactone
Universitas Sebelas Maret