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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    200
  • sponsor
    Shanghai Jiao Tong University School of Medicine
Updated on 16 December 2021
hypertension
antihypertensive drugs
amlodipine
essential hypertension

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

Details
Condition Hypertension
Treatment Spironolactone, Indapamide
Clinical Study IdentifierNCT04455178
SponsorShanghai Jiao Tong University School of Medicine
Last Modified on16 December 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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 Criteria

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)
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