NCT04455178

The Comparison Between Spironolactone and Indapamide Monotherapy or in Combination With Amlodipine to Reduce the Risk of Heart Failure

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: All
• Age: 45 Years
• Healthy volunteers: Not accepted

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), indapamide (1.5mg/tablet) and amlodipine (5mg/tablet). 3. Rationale: Our hypothesis of the present trial is that spironolactone is superior to indapamide in cardiovascular prevention in hypertensive patients, with the possible addition of amlodipine. Before a clinical outcome trial is considered, the present feasibility trial is designed to compare the efficacy of antihypertensive regimens based on these two drugs on blood pressure and several measurements of organ damage. 4. Objective: To evaluate the effects of spironolactone (either with or without amlodipine), in comparison with indapamide (either with or without amlodipine), on the extent of blood pressure reduction. 5. Study design: Multi-center (five sites), prospective, randomized, open-label, blinded-end point study with active treatment arm (study duration - 12 weeks) 6. Study population: Men and Women aged over 45 years (n=200) meeting the inclusion/exclusion criteria. 7. Randomization and treatment: After stratification by centers, eligible patients will be randomly divided into two groups, taking spironolactone (20mg tablet) once a day or indapamide (1.5mg tablet) once a day. Spironolactone may be up-titrated to 40mg daily and indapamide may be up-titrated to 3mg daily at 4-week or 8-week visit. At 8-week visit, if needed, we will add amlodipine at 5 or 10 mg once daily. 8. Follow up: 12 weeks. 9. Sample size: a total of 200 patients should be enrolled in the combination. 10. Timeline: After obtaining the approval of Ethics Committee of Ruijin Hospital in June 2020, recruitment will start. Patients enrollment will be performed between June 2020 to November 2020. All patients should be followed up before July 2021.

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), indapamide (1.5mg/tablet) and amlodipine (5mg/tablet). 3. Rationale: Our hypothesis of the present trial is that spironolactone is superior to indapamide in cardiovascular prevention in hypertensive patients, with the possible addition of amlodipine. Before a clinical outcome trial is considered, the present feasibility trial is designed to compare the efficacy of antihypertensive regimens based on these two drugs on blood pressure and several measurements of organ damage. 4. Objective: To evaluate the effects of spironolactone (either with or without amlodipine), in comparison with indapamide (either with or without amlodipine), on the extent of blood pressure reduction. 5. Study design: Multi-center (five sites), prospective, randomized, open-label, blinded-end point study with active treatment arm (study duration - 12 weeks) 6. Study population: Men and Women aged over 45 years (n=200) meeting the inclusion/exclusion criteria. Adult subjects with essential hypertension will be included. Specific criteria are as follows: Male and 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 7. Randomization and treatment: After stratification by centers, eligible patients will be randomly divided into two groups, taking spironolactone (20mg tablet) once a day or indapamide (1.5mg tablet) once a day. Spironolactone may be up-titrated to 40mg daily and indapamide may be up-titrated to 3mg daily at 4-week or 8-week visit. At 8-week visit, if needed, we will add amlodipine at 5 or 10 mg once daily. 8. Follow up: 12 weeks. Patients will be followed up every 4 weeks. Ambulatory and office blood pressure will be measured. Medical history should be recorded. Clinical examinations including blood biochemical tests (serum creatinine, uric acid and electrolytes) should be performed. 9. Sample size: a total of 200 patients should be enrolled in the combination. 10. Timeline: After obtaining the approval of Ethics Committee of Ruijin Hospital in June 2020, recruitment will start. Patients enrollment will be performed between June 2020 to November 2020. All patients should be followed up before July 2021. 11. Organization: The Centre for Epidemiological Studies and Clinical Trials, Ruijin Hospital, Shanghai, China

Conditions

• Hypertension

Interventions

Type	Name	Description
DRUG	Spironolactone	spironolactone 20mg once daily, up-titrated to 40mg once daily at 4-week or 8-week visit
DRUG	Indapamide	indapamide 1.5mg once daily, up-titrated to 3mg once daily at 4-week or 8-week visit

Timeline

• Start date: 2020-09-23
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2020-07-02
• Last updated: 2021-12-08

Locations

4 sites across 1 country: China