| Study name |
Aldosterone antagonist delays the progression of diastolic dysfunction in patients with hypertension and myocardial hypertrophy: a randomised controlled clinical trial |
| Methods |
Study design: parallel RCT
Anticipated completion date: 31 December 2018 |
| Participants |
Estimated enrolment: 466
Inclusion criteria:
Patient with essential hypertension aged 50 to 80 years old, diagnostic criteria referred to Guidelines for prevention and treatment of hypertension in China 2010; echocardiographic signs of LVH (LV mass index (LVMI) was > 125 g/m2 for men and > 110 g/m2 for women); Suspected LV diastolic dysfunction E/E: 8‐15; LVEF ≥ 50%; Voluntarily participate and sign the informed consent form.
Exclusion criteria:
Heart failure with reduced ejection fraction and stage C or D of heart failure with preserved ejection fraction; organic heart disease (coronary artery disease, valvular heart disease, cardiomyopathy, congenital heart disease); secondary hypertension; documented contraindication or allergy to aldosterone antagonist therapy; patient received aldosterone antagonist therapy in recent three months; electrolyte disturbance; severe kidney dysfunction: eGFR<30ml/min/1.73m2; severe liver dysfunction.
|
| Interventions |
Spironolactone versus placebo |
| Outcomes |
Left ventricular diastolic function (TDI: E/E’); Clinical composite end point (stage C or D of heart failure with preserved heart failure, hospitalization due to heart failure and cardiac death); LVMI; LVEF |
| Starting date |
October 2016 |
| Contact information |
Changqian Wang: forrestgu@sina.com |
| Notes |
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