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

December 7, 2021 updated by: Ji-Guang Wang, Shanghai Jiao Tong University School of Medicine
  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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China, 200025
        • Recruiting
        • Shanghai Institite of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine
    • Jiangsu
      • Dongtai, Jiangsu, China
        • Recruiting
        • Dongtai Renmin Hospital
        • Contact:
      • Kunshan, Jiangsu, China
        • Not yet recruiting
        • Kunshan First Renmin Hospital
        • Contact:
    • Shanxi
      • Changzhi, Shanxi, China
        • Recruiting
        • Changzhi Heping Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
pulse wave velocity
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
systolic blood pressure
Time Frame: 12 weeks
12 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
NT-proBNP
Time Frame: 12 weeks
NT-proBNP level will be measured by Roche Diagnostics.
12 weeks
Type I & III procollagen
Time Frame: 12 weeks
Type I & III procollagen level will be measured using a commercial ELISA kit
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai Jiao Tong University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 23, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 29, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 29, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 2, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 8, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 7, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SIRRHF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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