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

Last updated: December 7, 2021
Sponsor: Shanghai Jiao Tong University School of Medicine
Overall Status: Active - Recruiting

Phase

4

Condition

Williams Syndrome

Congestive Heart Failure

Chest Pain

Treatment

N/A

Clinical Study ID

NCT04455178
SIRRHF
  • Ages > 45
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria: Adult subjects with essential hypertension will be included. Specific criteria are asfollows

  1. Male and post menopause female subjects participates (OK with more women is preferred)
  2. Age ≥45 years
  3. Clinic systolic BP: 140 -179 mmHg (untreated or on monotherapy treatment)
  4. Waist Circumference (WC) ≥90 cm for male and ≥85 cm for female

Exclusion

Exclusion Criteria:

  1. Confirmed secondary hypertension
  2. Hyperkalemia (serum potassium concentration ≥5.0 mmol/L) or hypokalemia (serumpotassium concentration ≤3.5 mmol/L)
  3. Contraindication for the treatment drugs or current use of spironolactone, indapamideor amlodipine
  4. Chronic kidney disease (eGFR≤45 ml/min 1.73 m² or serum creatinine ≥ 2 mg/dl)
  5. Expected lifespan ≤6 months
  6. Treated subjects in whom withdrawal of antihypertensive treatment is deemed unethicalby the investigator (e.g. because of the existence of compelling indications otherthan hypertension for continuous use of previously used antihypertensive agent)
  7. Contraindications to study treatments as detailed in the relative Summaries of medicalProduct Characteristics for spironolactone, indapamide or amlodipine (this includeshypersensitivity, pregnancy and lactation)
  8. Diagnosed cardiovascular diseases other than hypertension (coronary heart disease,heart failure or left ventricular systolic dysfunction of any degree, atrialfibrillation or frequent arrhythmias, valvular or congenital heart disease,cardiomyopathies, cerebrovascular disease, peripheral artery disease, or aorticaneurysm)
  9. Subjects with conditions other than those mentioned above, where compellingindications for the use of any specific class of antihypertensive medication exist,according to the current (e.g. European Society of Cardiology) guidelines
  10. Other conditions deemed relevant by the investigator (including respiratory disorders,liver disease, renal disease, thyroid disorders)

Study Design

Total Participants: 200
Study Start date:
September 23, 2020
Estimated Completion Date:
December 31, 2023

Study 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

Connect with a study center

  • Dongtai Renmin Hospital

    Dongtai, Jiangsu
    China

    Active - Recruiting

  • Kunshan First Renmin Hospital

    Kunshan, Jiangsu
    China

    Site Not Available

  • Changzhi Heping Hospital

    Changzhi, Shanxi
    China

    Active - Recruiting

  • Shanghai Institite of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine

    Shanghai, 200025
    China

    Active - Recruiting

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