HypertensionPhase 4NCT04929600

Sacubitril/Valsartan Versus Amlodipine in Hypertension and Left Ventricular Hypertrophy.

A Phase 4 study testing sacubitril/valsartan and Amlodipine in people with Hypertension and Left Ventricular Hypertrophy, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

1. Study name: Prospective Comparison of Angiotensin receptor neprilysin inhibitor (ARNI) with Amlodipine on ventricular remodeling in hypertension and left ventricular hypertrophy. 2. Medicine: sacubitril/valsartan (ARNI, 200mg tablet) and the matching placebo; amlodipine (5mg tablet) and the matching placebo. 3. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hypertension, Left Ventricular Hypertrophy
What is being tested?: sacubitril/valsartan and Amlodipine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 120 participants
Where: 1 siteChina
Study dates: 28 Nov 2021to Dec 2023
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Aged ≥18;
Essential mild to moderate hypertension (office systolic blood pressure (SBP) ≥ 140 and < 180mmHg in untreated patients or patients with taking single antihypertensive drugs (not including single-pill combination))；
Echocardiographic diagnosis of LVH，LVMI: male≥115g/m2, female≥ 95g/m2;
Ability to understand the study requirements and provide informed consent.

Who cannot join

Hypersensitivity history to any study drug or similar drug (ARB, ACEI, neprilysin inhibitor；
Severe renal insufficiency (eGFR < 30 mL/min/1.73m2);
Hyperkalemia (serum potassium > 5mmol/L);
Active liver disease or hepatic insufficiency (AST or ALT > 3 times upper limit of normal);
History of malignancy over the past 5 years;
Severe disease patients with life expectancy of < 1 year;

Show all 12Show fewer

Previous or current diagnosis of heart failure;
Stroke or myocardial infarction within 6 months;
Previous or current atrial fibrillation, frequent ventricular premature beats, supraventricular tachycardia;
Patients who are receiving other study drugs or study medical devices;
Pregnant or lactating women;
Other circumstances that patients are not appropriate for the study upon the investigator's judgment.

Trial locations and contacts

1 site in 1 country.

China1 site, 1 recruiting

Shanghai Institite of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, 200025
Jiguang Wang, MD, PhD, 86-21-64370045 ext. 610911, jiguang_wang_jgw@yahoo.com
Recruiting

Other trials in China

About this study

Official title: Prospective Comparison of Angiotensin Receptor Neprilysin Inhibitor (ARNI) With Amlodipine on Ventricular Remodeling in Hypertension and Left Ventricular Hypertrophy.

Study name: Prospective Comparison of Angiotensin receptor neprilysin inhibitor (ARNI) with Amlodipine on ventricular remodeling in hypertension and left ventricular hypertrophy.
Medicine: sacubitril/valsartan (ARNI, 200mg tablet) and the matching placebo; amlodipine (5mg tablet) and the matching placebo.
Rationale: according to the results of previous clinical studies, ARNI has obvious advantages in improving cardiac remodeling and reducing blood pressure. However, there is no evidence to demonstrate the efficacy of ARNI in reducing blood pressure and improving ventricular remodeling in hypertension patients with left ventricular hypertrophy (LVH) compared with calcium channel blockers.
Objective: to demonstrate the superior efficacy of ARNI on improvement of LVH and blood pressure control compared with amlodipine in hypertension patients with LVH.
Study design: This study This is a 24-week prospective, randomized, active-controlled, double-blind, multi-center study, with two equally sized treatment groups: sacubitril/valsartan (200mg tablet); amlodipine (5mg tablet).
Study population: men or women aged over 18 years; Untreated patients or patients with taking single antihypertensive drugs; Essential mild to moderate hypertension; Echocardiographic diagnosis of LVH.
Randomization and treatment: Eligible patients will be randomly divided into 2 groups, taking one pill of sacubitril/valsartan (200mg tablet) + one pill of matching placebo of amlodipine daily, or one pill of amlodipine (5 mg/tablet) + one pill of matching placebo of sacubitril/valsartan daily.
Follow up: after meeting the inclusion criteria, there will be 2-week placebo run-in. Then patients will be randomly assigned into ARNI group and amlodipine group. There will be 5 visiting points in the treatment period, which will be the 4th week, 8th week, 12th week, 18th week and 24th week.
Sample size: 120 patients in total.
Timeline: After obtaining the approval of Ethics Committee of Ruijin Hospital in April 2021, recruitment will start. Patients enrollment and follow-up will be performed between June 2021 to June 2022.

Read the detailed description

Study name: Prospective Comparison of Angiotensin receptor neprilysin inhibitor (ARNI) with Amlodipine on ventricular remodeling in hypertension and left ventricular hypertrophy.
Medicine: sacubitril/valsartan (ARNI, 200mg tablet) and the matching placebo; amlodipine (5mg tablet) and the matching placebo.
Rationale: according to the results of previous clinical studies, ARNI has obvious advantages in improving cardiac remodeling and reducing blood pressure. However, there is no evidence to demonstrate the efficacy of ARNI in reducing blood pressure and improving ventricular remodeling in hypertension patients with left ventricular hypertrophy (LVH) compared with calcium channel blockers.
Objective: to demonstrate the superior efficacy of ARNI on improvement of LVH and blood pressure control compared with amlodipine in hypertension patients with LVH.
Study design: This study This is a 24-week prospective, randomized, active-controlled, double-blind, multi-center study, with two equally sized treatment groups: sacubitril/valsartan (200mg tablet); amlodipine (5mg tablet).
Study population: men or women aged over 18 years will be screened for hypertension and LVH. Eligible patients should be untreated patients or patients with taking single antihypertensive drugs with essential mild to moderate hypertension (clinic systolic blood pressure ≥ 140 and < 180mmHg), and echocardiographic diagnosis of LVH (LVMI: male≥115g/m2, female≥ 95g/m2). Patients should have abilities to understand the study requirements and provide informed consent.
Randomization and treatment: After screening period and run-in period by centers, eligible patients will be randomly divided into 2 groups, taking one pill of sacubitril/valsartan (200mg tablet) + one pill of matching placebo of amlodipine daily, or one pill of amlodipine (5 mg/tablet) + one pill of matching placebo of sacubitril/valsartan daily. At the 12th week of treatment, if systolic blood pressure ≥ 120 mmHg or diastolic blood pressure ≥ 80 mmHg and no safety problems, dosage titration (sacubitril/valsartan 200mg QD to 400mg QD, amlodipine 5mg QD to 10mg QD) should be conducted.
Follow up: after meeting the inclusion criteria, there will be 2-week placebo run-in. Clinic blood pressure, ambulatory blood pressure, echocardiography, NT proBNP, myocardial fibrosis index, concomitant medication records and adverse event records will be collected at randomization/the end of run-in period. Then patients will be randomly assigned into ARNI group and amlodipine group. The treatment will be observed for 24 weeks. There will be 5 visiting points in the treatment period, which will be the 4th week, 8th week, 12th week, 18th week and 24th week. Global longitudinal strain (GLS) was detected at randomization, the 12th week and 24th week.
Sample size: At least 60 eligible patients should be enrolled in each group, and a total of 120 patients should be enrolled in total.
Timeline: After obtaining the approval of Ethics Committee of Ruijin Hospital in April 2021, recruitment will start. Patients enrollment and follow-up will be performed between June 2021 to June 2022.
Organization: The Centre for Epidemiological Studies and Clinical Trials, Ruijin Hospital, Shanghai, China.

Conditions: Hypertension, Left Ventricular Hypertrophy
Being tested: sacubitril/valsartan, Amlodipine
Keywords: sacubitril/valsartan, amlodipine, blood pressure, global longitudinal strain
Medical subject headings: Hypertension, Hypertrophy, Left Ventricular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

sacubitril/valsartanDrug
Sacubitril/valsartan oral tablets (200mg) one pill a day + matching placebo of amlodipine one pill a day.
AmlodipineDrug
Amlodipine oral tablets (5mg) one pill a day + matching placebo of sacubitril/valsartan one pill a day.

Study groups in NCT04929600
Study group	Role	What they receive
Experimental	Experimental	One pill of sacubitril/valsartan (200mg tablet) + one pill of matching placebo of amlodipine daily. If possible, dosage titration should be conducted. Receives: Drug: sacubitril/valsartan
Comparator	Active comparator	One pill of amlodipine (5mg tablet) + one pill of matching placebo of sacubitril/valsartan daily. If possible, dosage titration should be conducted. Receives: Drug: Amlodipine

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in LVGLS after 24 weeks
Change in left ventricular global longitudinal strain (LVGLS) after 24-week treatments. At baseline and 24-week follow-up, all patients will undergo standard transthoracic echocardiography performed in the sinus rhythm using the Vivid E9 and E95 Echo-system (General Electric Medical Health, Milwaukee, Wisconsin, USA) equipped with a M5S transducer. LVGLS will be obtained from two-, three-, and four-chamber apical views, and LVGLS analysis will be performed using an offline software (EchoPac, Version 113; General Electric Medical Health).
Measured: Baseline and 24 weeks

Secondary outcomes (5)

Change in LVGLS after 12 weeks
Change in left ventricular global longitudinal strain (LVGLS) after 12-week treatments. At baseline and 12-week follow-up, all patients will undergo standard transthoracic echocardiography performed in the sinus rhythm using the Vivid E9 and E95 Echo-system (General Electric Medical Health, Milwaukee, Wisconsin, USA) equipped with a M5S transducer. LVGLS will be obtained from two-, three-, and four-chamber apical views, and LVGLS analysis will be performed using an offline software (EchoPac, Version 113; General Electric Medical Health).
Measured: Baseline and 12 weeks
Changes in LVMI after 24 weeks
At baseline and 24-week follow-up, all patients will undergo standard transthoracic echocardiography, Images of parasternal long axis view will be recorded to measure left ventricular end-diastole diameter (LVEDD), interventricular septal (IVS) and left ventricular posterior wall thickness (LVPW), and left ventricular mass will be calculated using the formula: 0.8*{1.04*[(LVEDD+IVS+LVPW)^3-LVEDD^3]}+0.6, and indexed by body surface area (BSA) as left ventricular mass index (LVMI).
Measured: Baseline and 24 weeks
Changes in LVMI after 12 weeks
At baseline and 12-week follow-up, all patients will undergo standard transthoracic echocardiography, Images of parasternal long axis view will be recorded to measure left ventricular end-diastole diameter (LVEDD), interventricular septal (IVS) and left ventricular posterior wall thickness (LVPW), and left ventricular mass will be calculated using the formula: 0.8*{1.04*[(LVEDD+IVS+LVPW)^3-LVEDD^3]}+0.6, and indexed by body surface area (BSA) as left ventricular mass index (LVMI).
Measured: Baseline and 12 weeks
Blood pressure after 24 weeks
Changes in clinic blood pressure, ambulatory blood pressureover 24 hours, daytime and nighttime after 24-week treatments.
Measured: Baseline and 24 weeks
Blood pressure after 12 weeks
Changes in clinic blood pressure, ambulatory blood pressureover 24 hours, daytime and nighttime after 12-week treatments.
Measured: Baseline and 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Nov 2021Dec 2023

First posted18 Jun 2021
Study start28 Nov 2021
Primary completionJun 2023 (estimated)
Study completionDec 2023 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HypertensionStudies of the same condition, open and under way.
More trials run by Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: After screening and run-in period, eligible patients will be randomly assigned into ARNI group (sacubitril/valsartan 200-400mg QD) or amlodipine group (amlodipine 5-10mg QD).
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 120 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04929600
Sponsor's protocol ID: PARASTRAIN
Status last verified: Apr 2023
First submitted: 15 Jun 2021
Last updated: 12 Apr 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

Each site lists its own contact. Pick the site nearest to you.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prospective Comparison of Angiotensin Receptor Neprilysin Inhibitor (ARNI) With Amlodipine on Ventricular Remodeling in Hypertension and Left Ventricular Hypertrophy.
ClinicalTrials.gov ID: NCT04929600
Acronym / sponsor ID: PARASTRAIN
Conditions: Hypertension, Left Ventricular Hypertrophy
Keywords: sacubitril/valsartan, amlodipine, blood pressure, global longitudinal strain
Phase: Phase 4
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 120 participants (estimated)
Lead sponsor: Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
Study start: 28 Nov 2021 (actual)
Primary completion: Jun 2023 (estimated)
Study completion: Dec 2023 (estimated)
First posted: 18 Jun 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study name: Prospective Comparison of Angiotensin receptor neprilysin inhibitor (ARNI) with Amlodipine on ventricular remodeling in hypertension and left ventricular hypertrophy.
Medicine: sacubitril/valsartan (ARNI, 200mg tablet) and the matching placebo; amlodipine (5mg tablet) and the matching placebo.
Rationale: according to the results of previous clinical studies, ARNI has obvious advantages in improving cardiac remodeling and reducing blood pressure. However, there is no evidence to demonstrate the efficacy of ARNI in reducing blood pressure and improving ventricular remodeling in hypertension patients with left ventricular hypertrophy (LVH) compared with calcium channel blockers.
Objective: to demonstrate the superior efficacy of ARNI on improvement of LVH and blood pressure control compared with amlodipine in hypertension patients with LVH.
Study design: This study This is a 24-week prospective, randomized, active-controlled, double-blind, multi-center study, with two equally sized treatment groups: sacubitril/valsartan (200mg tablet); amlodipine (5mg tablet).
Study population: men or women aged over 18 years; Untreated patients or patients with taking single antihypertensive drugs; Essential mild to moderate hypertension; Echocardiographic diagnosis of LVH.
Randomization and treatment: Eligible patients will be randomly divided into 2 groups, taking one pill of sacubitril/valsartan (200mg tablet) + one pill of matching placebo of amlodipine daily, or one pill of amlodipine (5 mg/tablet) + one pill of matching placebo of sacubitril/valsartan daily.
Follow up: after meeting the inclusion criteria, there will be 2-week placebo run-in. Then patients will be randomly assigned into ARNI group and amlodipine group. There will be 5 visiting points in the treatment period, which will be the 4th week, 8th week, 12th week, 18th week and 24th week.
Sample size: 120 patients in total.
Timeline: After obtaining the approval of Ethics Committee of Ruijin Hospital in April 2021, recruitment will start. Patients enrollment and follow-up will be performed between June 2021 to June 2022.

Detailed description

Study name: Prospective Comparison of Angiotensin receptor neprilysin inhibitor (ARNI) with Amlodipine on ventricular remodeling in hypertension and left ventricular hypertrophy.
Medicine: sacubitril/valsartan (ARNI, 200mg tablet) and the matching placebo; amlodipine (5mg tablet) and the matching placebo.
Rationale: according to the results of previous clinical studies, ARNI has obvious advantages in improving cardiac remodeling and reducing blood pressure. However, there is no evidence to demonstrate the efficacy of ARNI in reducing blood pressure and improving ventricular remodeling in hypertension patients with left ventricular hypertrophy (LVH) compared with calcium channel blockers.
Objective: to demonstrate the superior efficacy of ARNI on improvement of LVH and blood pressure control compared with amlodipine in hypertension patients with LVH.
Study design: This study This is a 24-week prospective, randomized, active-controlled, double-blind, multi-center study, with two equally sized treatment groups: sacubitril/valsartan (200mg tablet); amlodipine (5mg tablet).
Study population: men or women aged over 18 years will be screened for hypertension and LVH. Eligible patients should be untreated patients or patients with taking single antihypertensive drugs with essential mild to moderate hypertension (clinic systolic blood pressure ≥ 140 and < 180mmHg), and echocardiographic diagnosis of LVH (LVMI: male≥115g/m2, female≥ 95g/m2). Patients should have abilities to understand the study requirements and provide informed consent.
Randomization and treatment: After screening period and run-in period by centers, eligible patients will be randomly divided into 2 groups, taking one pill of sacubitril/valsartan (200mg tablet) + one pill of matching placebo of amlodipine daily, or one pill of amlodipine (5 mg/tablet) + one pill of matching placebo of sacubitril/valsartan daily. At the 12th week of treatment, if systolic blood pressure ≥ 120 mmHg or diastolic blood pressure ≥ 80 mmHg and no safety problems, dosage titration (sacubitril/valsartan 200mg QD to 400mg QD, amlodipine 5mg QD to 10mg QD) should be conducted.
Follow up: after meeting the inclusion criteria, there will be 2-week placebo run-in. Clinic blood pressure, ambulatory blood pressure, echocardiography, NT proBNP, myocardial fibrosis index, concomitant medication records and adverse event records will be collected at randomization/the end of run-in period. Then patients will be randomly assigned into ARNI group and amlodipine group. The treatment will be observed for 24 weeks. There will be 5 visiting points in the treatment period, which will be the 4th week, 8th week, 12th week, 18th week and 24th week. Global longitudinal strain (GLS) was detected at randomization, the 12th week and 24th week.
Sample size: At least 60 eligible patients should be enrolled in each group, and a total of 120 patients should be enrolled in total.
Timeline: After obtaining the approval of Ethics Committee of Ruijin Hospital in April 2021, recruitment will start. Patients enrollment and follow-up will be performed between June 2021 to June 2022.
Organization: The Centre for Epidemiological Studies and Clinical Trials, Ruijin Hospital, Shanghai, China.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: After screening and run-in period, eligible patients will be randomly assigned into ARNI group (sacubitril/valsartan 200-400mg QD) or amlodipine group (amlodipine 5-10mg QD).

Arm	Type	Receives
Experimental	Experimental	Drug: sacubitril/valsartanOne pill of sacubitril/valsartan (200mg tablet) + one pill of matching placebo of amlodipine daily. If possible, dosage titration should be conducted.
Comparator	Active comparator	Drug: AmlodipineOne pill of amlodipine (5mg tablet) + one pill of matching placebo of sacubitril/valsartan daily. If possible, dosage titration should be conducted.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Aged ≥18;
Essential mild to moderate hypertension (office systolic blood pressure (SBP) ≥ 140 and < 180mmHg in untreated patients or patients with taking single antihypertensive drugs (not including single-pill combination))；
Echocardiographic diagnosis of LVH，LVMI: male≥115g/m2, female≥ 95g/m2;
Ability to understand the study requirements and provide informed consent.

Key exclusion criteria (12 listed)

Hypersensitivity history to any study drug or similar drug (ARB, ACEI, neprilysin inhibitor；
Severe renal insufficiency (eGFR < 30 mL/min/1.73m2);
Hyperkalemia (serum potassium > 5mmol/L);
Active liver disease or hepatic insufficiency (AST or ALT > 3 times upper limit of normal);
History of malignancy over the past 5 years;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
sacubitril/valsartanSacubitril/valsartan oral tablets (200mg) one pill a day + matching placebo of amlodipine one pill a day.	Drug	Experimental
AmlodipineAmlodipine oral tablets (5mg) one pill a day + matching placebo of sacubitril/valsartan one pill a day.	Drug	Comparator

Primary outcome

Change in LVGLS after 24 weeks
Time frame: Baseline and 24 weeks
Change in left ventricular global longitudinal strain (LVGLS) after 24-week treatments. At baseline and 24-week follow-up, all patients will undergo standard transthoracic echocardiography performed in the sinus rhythm using the Vivid E9 and E95 Echo-system (General Electric Medical Health, Milwaukee, Wisconsin, USA) equipped with a M5S transducer. LVGLS will be obtained from two-, three-, and four-chamber apical views, and LVGLS analysis will be performed using an offline software (EchoPac, Version 113; General Electric Medical Health).

5 secondary outcomes

Change in LVGLS after 12 weeks
Time frame: Baseline and 12 weeks
Changes in LVMI after 24 weeks
Time frame: Baseline and 24 weeks
Changes in LVMI after 12 weeks
Time frame: Baseline and 12 weeks
Blood pressure after 24 weeks
Time frame: Baseline and 24 weeks
Blood pressure after 12 weeks
Time frame: Baseline and 12 weeks

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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

Shanghai, China

86-21-64370045 ext. 610911

jiguang_wang_jgw@yahoo.com

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing sacubitril/valsartan and Amlodipine in people with Hypertension and Left Ventricular Hypertrophy, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in LVGLS after 24 weeks (time frame: Baseline and 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04929600.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2023.