Resistant HypertensionPhase 4NCT07888504
Low-Dose Spironolactone in Hemodialysis Patients With Resistant Hypertension
A Phase 4 study testing Spironolactone in people with Resistant Hypertension and Kidney Failure, Chronic, run by Universitas Sebelas Maret at 1 site in Indonesia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Resistant Hypertension, Kidney Failure, Chronic, Hemodialysis
- What is being tested?
- Spironolactone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteIndonesia
- Study dates
- 20 Aug 2024to 31 Oct 2024
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years or older
- Stage 5 chronic kidney disease on maintenance hemodialysis twice weekly
- Clinically stable outpatient without clinical signs of volume overload
- Resistant hypertension: office systolic blood pressure of 140 mmHg or higher and/or diastolic blood pressure of 90 mmHg or higher despite three antihypertensive drug classes including a diuretic, after lifestyle advice
- Written informed consent from the patient or a family member
Who cannot join
- Previous spironolactone use
- Hyperkalemia
- Use of drugs other than routine clinic drugs (antihypertensive drugs, calcium carbonate, and folic acid)
- Infection or sepsis, malignancy, or autoimmune disease
- Acute complications needing hospital care, such as acute pulmonary edema, severe electrolyte disorders, uremic syndrome, hypertensive urgency or emergency, or hyperglycemic or hypoglycemic crises
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Dr. Moewardi General Hospital
Surakarta, Central Java, 57126
About this study
Official title: Low-Dose Spironolactone and Changes in Blood Pressure, Heart Rate Variability, and Inflammatory and Cardiac Biomarkers in Hemodialysis Patients With Resistant Hypertension: A Single-Arm Pre-Post Study
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.
Read the detailed description
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.
- Being tested
- Spironolactone
- Keywords
- spironolactone, mineralocorticoid receptor antagonist, heart rate variability, interleukin-6, NT-proBNP
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpironolactoneDrug
Spironolactone 12.5 mg taken orally once daily for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Spironolactone 12.5 mg | Experimental | Oral spironolactone 12.5 mg once daily for 6 weeks, added to the existing antihypertensive regimen. Receives: Drug: Spironolactone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in systolic blood pressure
Office systolic blood pressure (mmHg). Change = week-6 value minus baseline value.
Measured: Baseline and week 6
Change in diastolic blood pressure
Office diastolic blood pressure (mmHg). Change = week-6 value minus baseline value.
Measured: Baseline and week 6
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: Baseline and week 6
Change in serum interleukin-6
Serum interleukin-6 (pg/mL) measured by ELISA. Change = week-6 value minus baseline value.
Measured: 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.
Measured: 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.
Measured: Baseline and week 6
Change in serum potassium
Serum potassium (mmol/L), the main safety measure. Change = week-6 value minus baseline value.
Measured: Baseline and week 6
Change in serum urea and creatinine
Serum urea and creatinine (mg/dL). Change = week-6 value minus baseline value.
Measured: Baseline and week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2026
- Study start20 Aug 2024
- Primary completion31 Oct 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resistant HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants received spironolactone 12.5 mg daily for 6 weeks. Outcomes were compared before and after treatment.
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Sebelas Maret
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nurhasan Agung Prabowo, MD, Universitas Sebelas Maret
- Investigators
- Nurhasan Agung Prabowo, MD, Principal investigator, Universitas Sebelas Maret
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07888504
- Sponsor's protocol ID
- KEPK-RSDM-2071-VIII-HREC-2024
- Other IDs
- 1.779/VIII/HREC/2024, 2.255/IX/HREC/2024
- Status last verified
- Oct 2026
- First submitted
- 14 Oct 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be posted publicly. De-identified data are available from the study team on reasonable request.