NCT07137364Recruiting
Efficacy of Spironolactone Combined With Antihypertensive Drugs in Patients With Primary Aldosteronism
Source: ClinicalTrials.gov · Last updated 22 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The goal of this observational study is to learn about the optimal dose of spironolactone treatment and the long-term outcomes on cardiovascular and cerebrovascular events in patients with lateralized PA who are unwilling to undergo surgery. The main question it aims to answer is: 1. What is the long-term effect of spironolactone treatment for lateralized PA? 2. What is the optimal dose of spironolactone treatment for the relief of renin inhibition in patients with lateralized PA? Participants will receive spironolactone treatment as part of their regular medical care for more than 12 months, and their clinical indicators, including blood pressure, biochemical remission, cardiovascular and renal damage, and the incidence of cardiovascular and cerebrovascular events, will be analyzed.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 350 (estimated)
- First submitted
- 3 Aug 2025
- Start date
- 1 May 2022
- Primary completion date
- 1 Dec 2025
- Lead sponsor
- Third Military Medical University
- Diseases
- High blood pressure
- NCT number
- NCT07137364
What you commit to
- Study type: Observational
- Planned participants: 350
- From 1 May 2022 to the primary completion date, 1 Dec 2025
- 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.
Other illness
- Other confirmed secondary hypertension: pheochromocytoma, Cushing's syndrome, thyroid disorders, parathyroid disorders, acromegaly, renovascular disease, aortic disorders, chronic alcoholism, or drug dependence, etc.
- Adrenal insufficiency.
- Heart failure with NYHA class II-IV or stroke.
- Acute infection, malignancy, severe arrhythmia, psychiatric disorders, or drug/alcohol abuse.
Lab values
- Renal impairment or have history of renal disease: serum creatinine \> 1.5 × upper limit of normal (ULN), dialysis, or nephrotic syndrome.
- Significant hepatic dysfunction or have history of liver disease: AST or ALT \> 2 × ULN, cirrhosis, hepatic encephalopathy, esophageal varices or portosystemic shunt.
Other
- Hyperkalemia.
- Pregnancy or lactation.
- Participation in another clinical trial within the past 3 months.
- Inability to complete follow-up.
- Refusal to provide informed consent.
Who the study is looking for
- Male or female, aged 30\~65 years.
- PA patients with positive screening tests and saline suppression tests, and with AVS to determine lateralization. These patients have hypertension defined as office blood pressure ≥ 140/90 mmHg, or 24-hour ambulatory blood pressure showing average ≥ 130/80 mmHg, daytime blood pressure ≥ 135/85 mmHg, or nighttime blood pressure ≥ 120/70 mmHg.
- Patients with unilateral aldosterone-producing adenoma who decline surgery, or patients with non-adenoma, unilateral PA confirmed by AVS and meeting the above PA-related hypertension criteria.
- Provision of written informed consent to participate in the study.
Age in the registry: 30 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Daping Hospital, Army Medical Center of PLA Coordinator of this site? Confirm its status | Chongqing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.