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
- Are there results?
- None posted in the registry
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.
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07888504
- Acronym / sponsor ID
- KEPK-RSDM-2071-VIII-HREC-2024
- Keywords
- spironolactone, mineralocorticoid receptor antagonist, heart rate variability, interleukin-6, NT-proBNP
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Universitas Sebelas MaretUniversity, hospital or other
- Study start
- 20 Aug 2024 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 22 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants received spironolactone 12.5 mg daily for 6 weeks. Outcomes were compared before and after treatment.
| Arm | Type | Receives |
|---|---|---|
| Spironolactone 12.5 mg | Experimental | Drug: SpironolactoneOral spironolactone 12.5 mg once daily for 6 weeks, added to the existing antihypertensive regimen. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SpironolactoneSpironolactone 12.5 mg taken orally once daily for 6 weeks. | Drug | Spironolactone 12.5 mg |
Primary outcome
Change in systolic blood pressure
Time frame: Baseline and week 6
Office systolic blood pressure (mmHg). Change = week-6 value minus baseline value.
Change in diastolic blood pressure
Time frame: Baseline and week 6
Office diastolic blood pressure (mmHg). Change = week-6 value minus baseline value.
8 secondary outcomes
Change in SDNN
Time frame: Baseline and week 6
Change in RMSSD
Time frame: Baseline and week 6
Change in frequency-domain heart rate variability
Time frame: Baseline and week 6
Change in serum interleukin-6
Time frame: Baseline and week 6
Change in serum high-sensitivity C-reactive protein
Time frame: Baseline and week 6
Change in serum NT-proBNP
Time frame: Baseline and week 6
Change in serum potassium
Time frame: Baseline and week 6
Change in serum urea and creatinine
Time frame: Baseline and week 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be posted publicly. De-identified data are available from the study team on reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nurhasan Agung Prabowo, MD principal investigator
Universitas Sebelas Maret
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in systolic blood pressure (time frame: Baseline and week 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.