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NCT07888504CompletedPhase 4

Low-Dose Spironolactone in Hemodialysis Patients With Resistant Hypertension

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

Source: ClinicalTrials.gov · Last updated 22 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
21 (actual)
First submitted
14 Oct 2026
Start date
20 Aug 2024
Primary completion date
31 Oct 2024
Lead sponsor
Universitas Sebelas Maret
NCT number
NCT07888504

What you commit to

  • Study type: Interventional · Phase 4
  • Participants enrolled: 21
  • From 20 Aug 2024 to the primary completion date, 31 Oct 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous spironolactone use

Other illness

  • 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

Lab values

  • Use of drugs other than routine clinic drugs (antihypertensive drugs, calcium carbonate, and folic acid)

Other

  • Hyperkalemia

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Dr. Moewardi General Hospital
Coordinator of this site? Confirm its status
SurakartaIndonesiaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.