Could a common heart drug stop high blood pressure before it starts?
NCT ID NCT07727252
First seen Jul 27, 2026 · Last updated Jul 28, 2026 · Updated 1 time
Summary
This trial tests whether eplerenone, a drug that blocks the hormone aldosterone, can prevent the onset of high blood pressure in people aged 30–55 who have a mild, early form of primary aldosteronism but normal blood pressure. Participants will receive either eplerenone or a placebo for up to 5 years. The goal is to see if early treatment can protect the heart and kidneys and reduce the need for future blood pressure medications.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- eplerenone, a mineralocorticoid receptor antagonist
- What this could lead to
- If successful, this could establish a new strategy to prevent hypertension and heart/kidney damage in people with subclinical primary aldosteronism, potentially changing international treatment guidelines.
- What could go wrong
- This is an early-to-mid-stage trial, and the condition is not widely recognized. Risks include hyperkalemia, kidney injury, and low blood pressure. Results may not apply to broader populations.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Participants
-
About 880 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
-
Aug 2026
An estimate. Start dates often move.
- Expected to finish
-
Aug 2029
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
30 to 55 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age 30 to 55 years old (inclusive), both genders. * Body Mass Index (BMI) 18.5 to 35.0 kg/m² (inclusive). * Office blood pressure \< 140/90 mmHg, and no use of any antihypertensive drugs. Office blood pressure is measured at 3 visits with 1-week intervals. Patients rest in a seated position for 5 minutes before measurement, measured -times per visit, and the average of the 3 visits must meet the criteria. * Serum potassium in the low-normal or normal range. * Meeting diagnostic criteria: (A) ARR ≥ 2.52 ng/dL per pg/mL (chemiluminescence immunoassay), and PAC ≥ 6 ng/dL (blood sample required in the morning, fasting, after resting in a seated position for 30 minutes); OR (B) Renin ≤ 4.0 pg/mL; OR (C) Positive confirmatory test: Saline infusion test (SIT): PAC \> 6 ng/dL after 4 hours of isotonic saline infusion; OR Captopril challenge test (CCT): PAC suppression rate \< 30% at 2 hours after oral administration of 50mg captopril. * Adrenal thin-slice CT showing unilateral adrenal nodule (\<15 mm in diameter), bilateral adrenal micronodules (\<10 mm in diameter), or negative findings. Exclusion Criteria: * History of diagnosed hypertension, including office BP ≥ 140/90 mmHg, previous use of antihypertensive drugs, or previous ABPM meeting hypertension diagnostic criteria. * Other etiologies of secondary hypertension, including renal artery stenosis, pheochromocytoma, Cushing's syndrome, thyroid dysfunction, glucocorticoid-remediable aldosteronism, etc. * Severe renal insufficiency: eGFR \< 45 mL/min/1.73m² (CKD-EPI formula), or UACR \> 300 mg/g. * Abnormal baseline serum potassium: serum potassium \> 5.0 mmol/L, or serum potassium \< 3.0 mmol/L. * Severe hepatic insufficiency: Child-Pugh Class C, or ALT/AST \> 3 times the upper limit of normal (ULN). * History of allergy to eplerenone or any excipients of the study drug. * Pregnant, lactating women, or subjects planning to become pregnant during the study period. * History of adrenal surgery. * Severe cardiovascular diseases, including New York Heart Association (NYHA) Class IV heart failure, previous myocardial infarction, cerebral infarction, transient ischemic attack (TIA), severe arrhythmia, etc. * Severe comorbidities with an expected life expectancy of \<5 years, including malignant tumors, severe autoimmune diseases, end-stage organ failure, etc. * Use of drugs that cannot be discontinued prior to enrollment: strong CYP3A4 inhibitors (ketoconazole, itraconazole, clarithromycin, nefazodone, etc.); strong CYP3A4 inducers (rifampin, carbamazepine, phenytoin, St. John's wort, etc.); other MRAs, potassium-sparing diuretics (amiloride, triamterene), potassium supplements; systemic glucocorticoids (except physiological replacement), licorice preparations; long-term high-dose NSAIDs. * History of drug abuse, alcohol dependence, or psychiatric illness that may affect study completion, as judged by the investigator. * Participation in other clinical trials or use of other investigational drugs within 3 months prior to enrollment. * Any other conditions that, in the opinion of the investigator, may affect subject safety, trial compliance, or outcome assessment.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Subclinical primary aldosteronism are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.