Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT04455178 |
Other study ID # |
SIRRHF |
Secondary ID |
|
Status |
Recruiting |
Phase |
Phase 4
|
First received |
|
Last updated |
|
Start date |
September 23, 2020 |
Est. completion date |
December 31, 2023 |
Study information
Verified date |
December 2021 |
Source |
Shanghai Jiao Tong University School of Medicine |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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