Status:
UNKNOWN
The Comparison Between Spironolactone and Indapamide Monotherapy or in Combination With Amlodipine to Reduce the Risk of Heart Failure
Lead Sponsor:
Shanghai Jiao Tong University School of Medicine
Conditions:
Hypertension
Eligibility:
All Genders
45+ years
Phase:
PHASE4
Brief Summary
1. Study name: The comparison between spironolactone and indapamide monotherapy or in combination with amlodipine to reduce thr risk of heart failure (SIRRHF) 2. Medicine: spironolactone (20mg/tablet)...
Detailed Description
1. Study name: The comparison between spironolactone and indapamide monotherapy or in combination with amlodipine to reduce thr risk of heart failure (SIRRHF) 2. Medicine: spironolactone (20mg/tablet)...
Eligibility Criteria
Inclusion
- Adult subjects with essential hypertension will be included. Specific criteria are as follows
- Male and post menopause female subjects participates (OK with more women is preferred)
- Age ≥45 years
- Clinic systolic BP: 140 -179 mmHg (untreated or on monotherapy treatment)
- Waist Circumference (WC) ≥90 cm for male and ≥85 cm for female
Exclusion
- Confirmed secondary hypertension
- Hyperkalemia (serum potassium concentration ≥5.0 mmol/L) or hypokalemia (serum potassium concentration ≤3.5 mmol/L)
- Contraindication for the treatment drugs or current use of spironolactone, indapamide or amlodipine
- Chronic kidney disease (eGFR≤45 ml/min 1.73 m² or serum creatinine ≥ 2 mg/dl)
- Expected lifespan ≤6 months
- Treated subjects in whom withdrawal of antihypertensive treatment is deemed unethical by the investigator (e.g. because of the existence of compelling indications other than hypertension for continuous use of previously used antihypertensive agent)
- Contraindications to study treatments as detailed in the relative Summaries of medical Product Characteristics for spironolactone, indapamide or amlodipine (this includes hypersensitivity, pregnancy and lactation)
- Diagnosed cardiovascular diseases other than hypertension (coronary heart disease, heart failure or left ventricular systolic dysfunction of any degree, atrial fibrillation or frequent arrhythmias, valvular or congenital heart disease, cardiomyopathies, cerebrovascular disease, peripheral artery disease, or aortic aneurysm)
- Subjects with conditions other than those mentioned above, where compelling indications for the use of any specific class of antihypertensive medication exist, according to the current (e.g. European Society of Cardiology) guidelines
- Other conditions deemed relevant by the investigator (including respiratory disorders, liver disease, renal disease, thyroid disorders)
Key Trial Info
Start Date :
September 23 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04455178
Start Date
September 23 2020
End Date
December 31 2023
Last Update
December 8 2021
Active Locations (4)
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1
Dongtai Renmin Hospital
Dongtai, Jiangsu, China
2
Kunshan First Renmin Hospital
Kunshan, Jiangsu, China
3
Changzhi Heping Hospital
Changzhi, Shanxi, China
4
Shanghai Institite of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, China, 200025