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

Occurrence of symptomatic stroke ( ischemic or hemorrhagic)

Stroke is defined as a rapid onset of focal (or global) disturbance of cerebral function lasting more than 24 hours (except interrupted by surgery or death) without resolution of symptoms according to the World Health Organization. The diagnosis of stroke is confirmed by strict neurological examination, computed tomography (CT), or magnetic resonance imaging (MRI), and stroke subtypes are classified including ischemic or hemorrhagic, fatal or not fatal.

Time frame: 4 years

Occurrence of cardiac adverse events(Acute coronary syndrome and coronary revascularization)

Acute coronary syndrome includes myocardial infarction and hospitalization for unstable angina. The diagnosis of MI is based on the following criteria: (1) Patient has cardiac signs and symptoms, such as retrosternal pain last for at least 30 minutes, and not relieve to nitroglycerine during the attack; (2) Electrocardiographic abnormal findings of MI are observed; (3) Biochemical markers of cardiac damage are present.The diagnosis of unstable angina requires hospitalization for evaluation. The clinical presentation of unstable angina includes: (1) prolonged (\>20 min) angina pain at rest; (2) new onset angina; (3) post-MI angina; (4) recent destabilization of previously stable angina with at least Canadian Cardiovascular Society Class III angina characteristics. Patients are treated with coronary revascularization by either PCI or CABG due to acute coronary syndromes (ACS) and stable ischemic heart disease (SIHD).

Time frame: 4 years

Occurrence of aortic dissection and dissection aneurysm

Aortic dissection and dissection aneurysms are diagnosed based on basic information, blood biochemical information and imaging information.

Time frame: 4 years

Occurrence of Hospitalization for acute decompensated heart failure

Diagnosis of acute decompensated heart failure requires a hospitalization or emergency department visit which provides an infusion therapy for clinical signs and symptoms consistent with cardiac decompensation or inadequate cardiac pump function, such as increasing or new onset shortness of breath, peripheral edema, paroxysmal dyspnea, orthopnea, or hypoxia.

Time frame: 4 years

Occurrence of Atrial fibrillation

Diagnosis of AF requires rhythm evidence of an ECG showing the typical pattern including absolutely irregular RR intervals and no discernible, distinct P waves.

Time frame: 4 years

Occurrence of all-cause death

All-cause death includes death due to any reasons during the trial. Evidence for death includes death certificates from hospitals or reports of home visit from investigators.

Time frame: 4 years

Occurrence of Decline in renal function or development of end stage renal disease (ESRD)

Decline in renal function is assessed by any of the following: (1) For patients with chronic kidney disease (eGFR \<60 ml per minute per 1.73 m2) at baseline, the renal outcome was a composite of a decrease in the eGFR of 50% or more (confirmed by a subsequent laboratory test) or the development of ESRD requiring long-term dialysis or kidney transplantation; or (2) For participants without chronic kidney disease at baseline, the renal outcome was defined by a decrease in the eGFR of 30% or more to a value of less than 60 ml per minute per 1.73 m2.

Time frame: 4 years

First occurrence of diabetes mellitus

Diagnosis of incident diabetes mellitus includes the following criteria: (1) Fasting plasma glucose ≥ 126 mg/dl (≥ 7.0 mmol/dl); or (2) Oral glucose tolerance test 2-hour glucose in venous plasma ≥ 200 mg/dl (≥ 11.1 mmol/l); or (3) In a patient with classic symptoms of hyperglycemia or hyperglycemic crisis, a random plasma glucose ≥ 200 mg/dl (≥ 11.1 mmol/l); or (4) Glycosylated hemoglobin (HbA1c) ≥ 6.5% (48 mmol/mol).

Time frame: 4 years

First occurrence of nonalcoholic fatty liver

Diagnosis of nonalcoholic fatty liver disease includes the following criteria: (1) imaging or histological evidence of hepatic steatosis; (2) Except other causes of secondary fat accumulation in the liver.

Time frame: 4 years

Occurrence of Decline in cognitive function

Decline in cognitive function includes sensory disturbance, memory disorders and thinking disorders, which is assessed by mini-mental state examination (MMSE).

Time frame: 4 years

Changes in vascular elasticity from baseline（ABI and baPWV）

Ankle brachial index \[ABI\],and brachial-ankle pulse wave velocity(baPWV) well-established non-invasive techniques for evaluating obstruction and stiffness of peripheral artery respectively, are considered for the purposes of cardiovascular risk assessment. ABI is the ratio of the average systolic blood pressure measured in brachial/ankle, and an ABI between and including 0.9 and 1.2 is considered normal, while a lesser than 0.9 indicates arterial disease. The unit measure of baPWV value is cm per second.

Time frame: 1-4 years

Changes in urine protein from baseline

Time frame: 1-4 years

Changes in cardiac structural indicators from baseline

Ventricular septal thickness and left ventricular posterior wall thickness were evaluated mainly by echocardiography.

Time frame: 1-4 years

Blood pressure control rate

Blood pressure control was assessed by home blood pressure or ambulatory blood pressure for 7 consecutive days

Time frame: 1-3months