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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

PHASE4

Total Enrollment

8000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-16

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

REnin-guided TherApy With MinEralocorticoid Receptor Antagonists in Primary Aldosteronism - Feasibility Study

NCT06108427

Primary Aldosteronism

RECRUITING NA

Vascular Effects of Mineralocorticoid Receptor Antagonism in Kidney Disease

NCT02497300

Chronic Kidney Disease Albuminuria

COMPLETED PHASE2

Role of Mineralocorticoid Receptor in Diabetic Cardiovascular Disease

NCT00865124

Type 2 Diabetes Mellitus Vascular Disease

COMPLETED NA

Comparing the Efficacy and Safety of Finerenone and Spironolactone in the Treatment of Primary Aldosteronism

NCT05814770

Primary Aldosteronism Hypertension

NOT_YET_RECRUITING PHASE4

Unmitigated Aldosterone Signaling During Standard Clinical MRA Dosing

NCT07281014

Heart Failure

NOT_YET_RECRUITING PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypertension Hyperaldosteronaemia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Mineralocorticoid Receptor Antagonists(MRAs)

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.

Group Type EXPERIMENTAL

Mineralocorticoid Receptor Antagonists(MRAs)

Intervention Type DRUG

Participants will be treated with mineralocorticoid receptor antagonists(MRAs) in addition to the original antihypertensive drugs for 48 months.

Blank Control

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

Group Type PLACEBO_COMPARATOR

Blank control

Intervention Type OTHER

Participants will be treated with the original antihypertensive drugs for 48 months.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Mineralocorticoid Receptor Antagonists(MRAs)

Participants will be treated with mineralocorticoid receptor antagonists(MRAs) in addition to the original antihypertensive drugs for 48 months.

Intervention Type DRUG

Blank control

Participants will be treated with the original antihypertensive drugs for 48 months.

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Placebo

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No