Early Mineralocorticoid Receptor Antagonist Therapy for Low-Renin Essential Hypertension
Key facts
- Who runs it
- China National Center for Cardiovascular Diseases
- Where
- China1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Not yet recruiting
- Phase
- Phase 4
- People taking part
- 128 people, planned
- Starts
- 1 Dec 2026
- Expected to end
- 30 Apr 2028
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Eplerenone
- Telmisartan
- Record updated
- 12 November 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 17 criteriaShow less
Who can take part
- Age 18 years or older
- Either untreated hypertension, defined as mean seated office systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg, or hypertension currently treated with no more than two antihypertensive agents
- Plasma direct renin concentration <12 mU/L after the protocol-specified medication washout: at least 4 weeks for mineralocorticoid receptor antagonists, epithelial sodium channel inhibitors, and other diuretics; and at least 2 weeks for angiotensin-converting enzyme inhibitors, angiotensin II receptor blockers, and beta-blockers
- Willing and able to provide written informed consent
Who cannot take part
- Inability to tolerate the required medication washout period
- Chronic kidney disease with estimated glomerular filtration rate ≤45 mL/min/1.73 m² or urine dipstick protein >2+
- New York Heart Association functional class II-IV heart failure, coronary artery disease, or a history of transient ischemic attack, stroke, or atrial fibrillation
- Hepatic impairment with alanine aminotransferase or aspartate aminotransferase ≥2 times the upper limit of normal
- Secondary hypertension or another condition affecting blood pressure regulation, including licorice abuse, primary hyperparathyroidism, primary aldosteronism, autonomous cortisol secretion, hyperthyroidism, pheochromocytoma, renal artery stenosis, or known monogenic low-renin hypertension
- Known allergy or intolerance to any study medication or its components
- Any other condition that, in the investigator's judgment, makes participation unsuitable
- Current use of mineralocorticoid receptor antagonists or other medications that interfere with renin or aldosterone measurements, including glucocorticoids, oral estrogens, and sodium-glucose cotransporter 2 inhibitors
- Serum potassium ≥5.0 mmol/L
- Diabetes mellitus with glycated hemoglobin ≥7.5%
- Systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥120 mmHg
- Pregnancy, breastfeeding, or women of childbearing potential who are not using reliable contraception
- Body mass index ≥37.5 kg/m²
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
This study aims to evaluate the efficacy and safety of early initiation of eplerenone, a second-generation mineralocorticoid receptor antagonist, compared with standard antihypertensive treatment in adults with low-renin essential hypertension. The study will assess whether an eplerenone-based treatment strategy provides greater blood pressure reduction, improves blood pressure control, and reduces antihypertensive medication burden compared with standard treatment.
The 2 groups in the trial
- Early Eplerenone-Based TreatmentTreatment being tested
Participants will receive stepped antihypertensive treatment starting with eplerenone 50 mg orally once daily. Treatment will be intensified as needed by sequentially adding amlodipine 5 mg once daily, increasing eplerenone to 50 mg twice daily, increasing amlodipine to 5 mg twice daily, adding hydrochlorothiazide 12.5 mg once daily, adding doxazosin 4 mg once daily, and increasing hydrochlorothiazide to 25 mg once daily. Participants taking two antihypertensive drugs before washout will generally start with eplerenone plus amlodipine. Treatment adjustments will depend on blood pressure, tolerability, and safety assessments, with a target seated office blood pressure below 140/90 mmHg. Treatment will continue for 24 weeks.
Treatment: Eplerenone
- Standard TreatmentExisting treatment, for comparison
Participants will receive stepped antihypertensive treatment starting with telmisartan 40 mg orally once daily. Treatment will be intensified as needed by sequentially adding amlodipine 5 mg once daily, increasing telmisartan to 80 mg once daily, increasing amlodipine to 5 mg twice daily, adding hydrochlorothiazide 12.5 mg once daily, adding doxazosin 4 mg once daily, and increasing hydrochlorothiazide to 25 mg once daily. Participants taking two antihypertensive drugs before washout will generally start with telmisartan plus amlodipine. Treatment adjustments will depend on blood pressure, tolerability, and safety assessments, with a target seated office blood pressure below 140/90 mmHg. Treatment will continue for 24 weeks.
Treatment: Telmisartan
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Early Mineralocorticoid Receptor Antagonist Therapy for Low-Renin Essential Hypertension: A Randomized Controlled Study
- Record updated
- 12 November 2026