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

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ClinicalTrials.gov Identifier: NCT04455178
Recruitment Status : Recruiting
First Posted : July 2, 2020
Last Update Posted : August 10, 2020
Sponsor:
Information provided by (Responsible Party):
Ji-Guang Wang, Shanghai Jiao Tong University School of Medicine

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), 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.

Condition or disease Intervention/treatment Phase
Hypertension Drug: Spironolactone Drug: Indapamide Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Eligible patients will be randomly divided into two groups, taking spironolactone (20mg/tablet) once a day or indapamide (1.5mg/tablet) once a day.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Comparison Between Spironolactone and Indapamide Monotherapy or in Combination With Amlodipine to Reduce the Risk of Heart Failure
Estimated Study Start Date : August 15, 2020
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: Spironolactone
Spironolactone 20mg once daily
Drug: Spironolactone
spironolactone 20mg once daily, up-titrated to 40mg once daily at 4-week or 8-week visit

Active Comparator: Indapamide
Indapamide 1.5mg once daily
Drug: Indapamide
indapamide 1.5mg once daily, up-titrated to 3mg once daily at 4-week or 8-week visit




Primary Outcome Measures :
  1. pulse wave velocity [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. systolic blood pressure [ Time Frame: 12 weeks ]

Other Outcome Measures:
  1. NT-proBNP [ Time Frame: 12 weeks ]
    NT-proBNP level will be measured by Roche Diagnostics.

  2. Type I & III procollagen [ Time Frame: 12 weeks ]
    Type I & III procollagen level will be measured using a commercial ELISA kit



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Adult subjects with essential hypertension will be included. Specific criteria are as follows

  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 Criteria:

  1. Confirmed secondary hypertension
  2. Hyperkalemia (serum potassium concentration ≥5.0 mmol/L) or hypokalemia (serum potassium concentration ≤3.5 mmol/L)
  3. Contraindication for the treatment drugs or current use of spironolactone, indapamide or 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 unethical by the investigator (e.g. because of the existence of compelling indications other than hypertension for continuous use of previously used antihypertensive agent)
  7. 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)
  8. 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)
  9. 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
  10. Other conditions deemed relevant by the investigator (including respiratory disorders, liver disease, renal disease, thyroid disorders)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04455178


Locations
Layout table for location information
China, Jiangsu
Dongtai Renmin Hospital Recruiting
Dongtai, Jiangsu, China
Contact: Feng Xue, MD    18066157759    18066157759@163.com   
Kunshan First Renmin Hospital Not yet recruiting
Kunshan, Jiangsu, China
Contact: Ming Gu    15961676992    15962676992@126.com   
China, Shanxi
Changzhi Heping Hospital Recruiting
Changzhi, Shanxi, China
Contact: Zhiping Wang, MD    13015462258    czhpwzp@163.com   
China
Shanghai Institite of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine Recruiting
Shanghai, China, 200025
Contact: Jiguang Wang, MD, PhD    86-21-64370045 ext 610911    jiguang_wang_jgw@yahoo.com   
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
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Responsible Party: Ji-Guang Wang, Director of the Shanghai Institute of Hypertension, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT04455178    
Other Study ID Numbers: SIRRHF
First Posted: July 2, 2020    Key Record Dates
Last Update Posted: August 10, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ji-Guang Wang, Shanghai Jiao Tong University School of Medicine:
blood pressure
spironolactone
Additional relevant MeSH terms:
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Heart Failure
Cardiovascular Diseases
Heart Diseases
Indapamide
Spironolactone
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents
Antihypertensive Agents
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action