Effect of MRA on Cardiovascular Disease in Patients With Hypertension and Hyperaldosteronemia (EMRACHH)

Nanfang Li

Status and phase: Invitation-only; Phase 4

Conditions: Hypertension; Hyperaldosteronaemia

Treatments: Drug: Mineralocorticoid Receptor Antagonists(MRAs); Other: Blank control

Study type: Interventional

Funder types: Other

Identifiers

NCT05688579

A.HT.2022.8.4

Details and patient eligibility

About

Elevated aldosterone causes moderate to severe increase in blood pressure, and leads to various target organ damage including cardiovascular ones. Aldosterone has been considered one of the important risk factors for cardiovascular and cerebrovascular diseases. Currently, the use of mineralocorticoid receptor antagonists(MRA) has been proven to reduce blood pressure levels, but long-term prognostic data are lacking in hypertensive patients. Therefore, the purpose of this clinical trial is to assess the effect of MRA on cardiovascular disease in patients with Hypertension and Hyperaldosteronemia.

Full description

The trial will randomize about 7800 participants aged between 30 and 75 years with Hypertension and Hyperaldosteronemia(Plasma aldosterone concentration >12 ng/dl). All participants were randomly assigned to two different intervention groups. One group was treated with mineralocorticoid receptor antagonists(MRAs) (including spironolactone 20-60mg/ day, or eplerenone50-100mg/day, or finerenone 10-20mg/ day) in addition to the original antihypertensive drugs. One group was given the original antihypertensive drugs.

Enrollment: 8,000 estimated patients

Sex: All

Ages: 30 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age: 18-75 years old;
2. Blood pressure ≥140/90 mmHg, or have taken antihypertensive drugs;
3. Plasma aldosterone concentration> 12ng/ dL;
4. Serum potassium < 4.8mmol/L;
5. Signed the written informed consent.

Exclusion criteria

1. SBP/DBP≥190/120mmHg, DBP<60 mmHg;
2. Known secondary cause of hypertension, including pheochromocytoma, primary aldosteronism (adrenal tumor > 1cm), Cushing's syndrome, renal artery stenosis, renin tumor, connotation of aorta, etc.;
3. History of ischemic or hemorrhagic stroke within the last 3 months (not lacunar infarction and transient ischemic attack [TIA]).
4. History of Hospitalization for myocardial infarction or unstable angina, or coronary revascularization (PCI or CABG) within the last 3 months.
5. History of aortic dissection/dissection aneurysm rupture.
6. History of NYHA Grade III-IV heart failure or hospitalization Aggravated chronic heart failure upon admission within the last 3 months.
7. A history of persistent atrial fibrillation, atrial flutter, or other severe arrhythmias on admission (including sinus delay, diseased sinus, high atrioventricular block, frequent ventricular morning, 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 (ESRD) on dialysis, or estimated glomerular filtration rate (eGFR) <30 mL/min, or serum creatine >2.5 mg/dl [>221 umol/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. Those who have contraindications or allergies to MRAs.
14. Patients with hypoadrenocortical function.
15. Participating in other clinical trials.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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8,000 participants in 2 patient groups, including a placebo group

Mineralocorticoid Receptor Antagonists(MRAs)

Experimental group

Description:

Participants will treat with mineralocorticoid receptor antagonists(MRAs) (including spironolactone 20-60mg/ day, or eplerenone50-100mg/day, or finerenone 10-20mg/ day) in addition to the original antihypertensive drugs for 48 months.

Treatment:

Drug: Mineralocorticoid Receptor Antagonists(MRAs)

Blank Control

Placebo Comparator group

Description:

Participants will be given the original antihypertensive drugs for 48 months.

Treatment:

Other: Blank control