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Clinical study on the antihypertensive effect and safety of spironolactone in patients with essential hypertension complicated with hyperaldosteronemia

Clinical study on the antihypertensive effect and safety of spironolactone in patients with essential hypertension complicated with hyperaldosteronemia :

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500106602
Enrollment
Unknown
Registered
2025-07-27
Start date
2025-07-30
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Interventions

Self-control group:Drug intervention
Intervention group:Spironolactone 40mg
Control group:None

Sponsors

Guizhou Provincial People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Age: 30-75 years old; (2) Before drug treatment, the systolic blood pressure in the office was in the range of 160-190mmHg and/or the diastolic blood pressure was in the range of 100-120mmHg; (3) The family/office with more than 4 weeks of drug treatment and ambulate blood pressure is not up to the standard and within the above range (exceeding the target systolic/diastolic blood pressure 160pg/ml; (5) Blood potassium < 4.8mmol/L; (6)Sign written informed consent, accept random assignment, and expect good compliance.

Exclusion criteria

Exclusion criteria: 1) Age, consulting room blood pressure and ambulate blood pressure did not meet the inclusion criteria; 2) Secondary hypertension with definite diagnosis, including primary hyperaldosteronism, Cushing's syndrome, pheochromocytoma, renal artery stenosis, renin tumor, cocotation of the aorta, etc. 3) History of ischemic or hemorrhagic stroke within 3 months (excluding lacunar infarction and TIA). 4) hospitalization within 3 months due to myocardial infarction or unstable angina, or coronary revascularization (PCI or CABG). 5) History of aortic dissection/dissection aneurysm rupture. 6) Exacerbation of chronic heart failure during hospitalization for NYHAIII-IV heart failure within 3 months or upon admission. 7) A history of persistent atrial fibrillation, atrial flutter, or other severe arrhythmias upon admission (including bradysinus, diseased sinus, high atrioventricular block, frequent ventricular premature, etc.). 8) Severe liver disease or liver dysfunction: AST, ALT, or ALP > 5ULN (5 times the upper limit of normal), or BIL > 3ULN (3 times the upper limit of normal). 9) End-stage renal disease receiving dialysis or eGFR2.5mg/dL[>221µmol/L]). 10) Patients with serious physical diseases such as malignant tumors and autoimmune diseases. 11) Severe cognitive or mental impairment. 12) Pregnant and lactating women. 13) Participate in other clinical trials.

Design outcomes

Primary

MeasureTime frame
Blood pressure;

Countries

China

Contacts

Public ContactSongFang

Guizhou Provincial People's Hospital

2900991440@qq.com+86 186 8519 1199

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026