Heart Failure, SystolicPROSPER-HFNCT04803175
Sacubitril/Valsartan Versus Valsartan in Heart Failure With Improved Ejection Fraction
An observational study of Heart Failure, Systolic, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
Heart failure (HF) is a chronic disease with weakened heart muscles or abnormal pressure within the heart chambers result in breathlessness, leg edema, or fatigue. A subclass of HF shows reduced heart muscle contractility, which is represented by the left ventricular ejection fraction (LVEF). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Systolic
- What is being tested?
- Sacubitril-Valsartan and Valsartan
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 16 Mar 2021to Feb 2025
- How long will I take part?
- 12 Months
- Phase
- Observational
- 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
Study population: 1. Consecutive participant sampling was done for all eligible patients. 2. Patients visiting a specialized heart failure clinic at one of the top tertiary level hospitals in Seoul, Korea. Patients have a nationwide distribution geographically, and show a wide range of clinical presentations.
Who may be able to join
- Patient with a history of HF with reduced EF (HFrEF; LVEF <40 percent) and received treatment with sacubitril/valsartan for at least 3 months, after which showing improvement of LVEF to >40 percent and symptoms of NYHA functional class I or II
- serum NT-proBNP levels < 400 pg/dL for sinus rhythm and < 600pg/dL for atrial fibrillation
- Patients on stable doses of diuretics for 1 week
Who cannot join
- History of hospitalization for heart failure within 30 days before enrollment
- History of acute coronary syndrome (acute myocardial infarction or unstable angina), percutaneous coronary artery intervention or cardiac surgery within 30 days before enrollment
- History of cardiac resynchronization therapy within 90 days before screening
- Planned percutaneous or surgical coronary artery revascularization, or major cardiac surgery (coronary artery bypass, valvuloplasty, mechanical cardiac support or heart transplantation) within 90 days after enrollment
- Contraindicated or has history of hypersensitivity to RAS blockers including ACEI or ARB
- Use of inotropes
- Survival estimate < 3months
- Otherwise deemed as inappropriate by the attending physician
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul, 06351
Jinoh Choi, MD, PhD, 82234103417, choijean5@gmail.com
Yoonjee Park, MD, 821026729748, yoonjeedrpark@gmail.com
About this study
Official title: Prospective Comparison of Sacubitril/Valsartan Versus Valsartan on the Outcome of Heart Failure With Improved Ejection Fraction: a Pilot Study
Heart failure (HF) is a chronic disease with weakened heart muscles or abnormal pressure within the heart chambers result in breathlessness, leg edema, or fatigue. A subclass of HF shows reduced heart muscle contractility, which is represented by the left ventricular ejection fraction (LVEF). Valsartan is an angiotensin II receptor blocker, a major drug class for heart failure. Sacubitril/valsartan is a combination of 2 drugs, classified as a new class of drug called angiotensin receptor neprilysin inhibitor (ARNI). Although these medications are both first-line treatment in HF with reduced LVEF, recent guidelines encourage the use of sacubitril/valsartan in patients with ongoing symptoms. After successful treatment, some patients experience recovery of LVEF. In these patients, otherwise called heart failure with improved ejection fraction (HFiEF), it is not clear whether continued treatment with sacubitril/valsartan or valsartan is beneficial in terms of relapse of heart failure or worsening of LVEF. Therefore, the investigators aim to determine whether the treatment with sacubitril/valsartan versus valsartan differs in clinical outcomes after 1 year in HFiEF patients by observing the change in blood test markers of heart failure (N-terminal prohormone of brain natriuretic peptide; NT-proBNP) and aggravation of HF defined as reduced LVEF, congestive symptoms, hospitalization or death from HF.
Read the detailed description
- Background and study purpose Heart failure (HF) is caused by structural or functional abnormality of the myocardium or elevated intracardiac pressures, resulting in symptoms and signs of low cardiac output or congestion, such as dyspnea, peripheral edema, elevated jugular venous pressures, pulmonary congestion, and fatigue. HF with reduced left ventricular ejection fraction (HFrEF) is defined as an LVEF <40% by the 2013 American College of Cardiology/American Heart Association (ACC/AHA) guidelines. Recent guidelines recommend the use of angiotensin-converting enzyme inhibitors (ACEI)/angiotensin II receptor blocker (ARB)/angiotensin receptor neprilysin inhibitor (ARNI), beta blockers (BB), aldosterone antagonists (AA), and sodium-glucose co-transporter-2 inhibitors (SGLT2i) in HFrEF patients. ACEI/ARB/ARNI, collectively known as renin-angiotensin-system (RAS) blockers, are considered the most important drug class in the treatment for HFrEF and recently, ARNI is increasingly preferred as the first-choice drug. Unlike for initial treatment of HFrEF, continued treatment for patients who experience recovery of LVEF is not as well established. In these patients, called heart failure with improved ejection fraction (HFiEF), it is not clear whether continued treatment with sacubitril/valsartan or valsartan is beneficial in terms of relapse of heart failure or worsening of LVEF. Therefore, the investigators aim to determine whether the treatment with sacubitril/valsartan versus valsartan differs in clinical outcomes after 1 year in HFiEF patients by observing the change in serum N-terminal prohormone of brain natriuretic peptide (NT-proBNP) and clinical relapse of HF.
- Registry factors
- Source data verification will be done by comparing the data to electronic medical records and paper and electronic case report forms.
- Data dictionary with detailed description of each variables are given.
- Sample size assessment was calculated by comparing mean NT-proBNP levels at baseline and after 12 months in the two groups by two-sample t-test (two-sided, effect size=0.6, type I error=0.05, type II error=0.8, allocation ratio=1). With a drop-out rate of 10%, 50 patients in each group are needed. As the change of NT-proBNP in HFiEF with sacubitril/valsartan or valsartan has rarely been reported, estimation from the TRED-HF study (Lancet. 2019 Jan 5; 393(10166):61) was used as reference for effect size. This reference was a small study of 25 patients in each group. Therefore, the effect size used for calculation was modified to 0.6 rather than 0.8 by intuition of the investigators.
- Plan for missing data: To avoid unavailable data, clinical visits will be monitored and calls will be made for missed appointments. Uninterpretable or out-of-range results will be discussed by participating investigators through regular meetings.
- Statistical analysis Based on intention-to-treat analysis, the primary outcome (NT-proBNP changes) will be log-transformed and compared by paired t-tests. Baseline characteristics will be presented according to initial drug assignment and compared with the Mann-Whitney test for continuous variables or Fisher's exact test for categorical variables. Data are presented as median and IQR or as n (%). Occurrence of the secondary endpoint will be graphically displayed per group with Kaplan-Meier survival plots and compared with the log-rank test. Cox proportional hazards models will be used to investigate predictors of worsening NT-proBNP levels or occurrence of clinical adverse events in patients of each group. A p value less than 0.05 will be considered significant.
- Conditions
- Heart Failure, Systolic
- Being tested
- Sacubitril-Valsartan, Valsartan
- Keywords
- Heart Failure with reduced Ejection Fraction, Heart Failure with improved Ejection Fraction, Sacubitril/valsartan, Valsartan
- Medical subject headings
- Heart Failure, Systolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sacubitril-ValsartanDrug
Also called Entresto
Participants will receive individualized dosage and titration as part of routine medical care, and a the effect will be studied for at least 12 months. The investigator does not assign specific interventions to the study participants.
ValsartanDrug
Also called Diovan
Participants will receive individualized dosage and titration as part of routine medical care, and a the effect will be studied for at least 12 months. The investigator does not assign specific interventions to the study participants.
| Study group | Role | What they receive |
|---|---|---|
| Sacubitril/valsartan | Patients undergoing continued treatment with sacubitril/valsartan after improvement of LVEF >40% with > 3 months of sacubitril/valsartan treatment. Dose and titration schedule will be individualized by discretion of the attending physician. Receives: Drug: Sacubitril-Valsartan | |
| Valsartan | Patients undergoing continued treatment with valsartan after improvement of LVEF >40% with > 3 months of sacubitril/valsartan treatment. Dose and titration schedule will be individualized by discretion of the attending physician. Receives: Drug: Valsartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in NT-proBNP concentration
pg/ml
Measured: Baseline, 6 months, 12 months
Secondary outcomes (4)
Heart failure relapse
One or more of the following:
- LVEF <40 percent by cardiac imaging including but not refined to: echocardiography, cardiac magnetic resonance imaging
- symptomatic congestive heart failure: symptoms and signs of heart failure such as dyspnea, edema, abdominal fullness, and fatigue
Measured: 6 months and 12 months
Hospitalization for heart failure (HHF)
Hospitalization for acute decompensated heart failure
Measured: 6 months and 12 months
Death caused by heart failure
Heart failure being either the immediate or contributing cause of death.
Measured: 6 months and 12 months
Mortality
All-cause mortality
Measured: 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2021
- Study start16 Mar 2021
- Primary completionFeb 2024 (estimated)
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Heart Failure, SystolicStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin-Oh Choi, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04803175
- Sponsor's protocol ID
- 2020-08-082
- Acronym
- PROSPER-HF
- Status last verified
- Aug 2021
- First submitted
- 25 Feb 2021
- Last updated
- 18 Aug 2021
- Results posted
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The access criteria has not been discussed yet.
Publications
Halliday BP, Wassall R, Lota AS, Khalique Z, Gregson J, Newsome S, Jackson R, Rahneva T, Wage R, Smith G, Venneri L, Tayal U, Auger D, Midwinter W, Whiffin N, Rajani R, Dungu JN, Pantazis A, Cook SA, Ware JS, Baksi AJ, Pennell DJ, Rosen SD, Cowie MR, Cleland JGF, Prasad SK. Withdrawal of pharmacological treatment for heart failure in patients with recovered dilated cardiomyopathy (TRED-HF): an open-label, pilot, randomised trial. Lancet. 2019 Jan 5;393(10166):61-73. doi: 10.1016/S0140-6736(18)32484-X. Epub 2018 Nov 11.
PubMed 30429050Januzzi JL Jr, Prescott MF, Butler J, Felker GM, Maisel AS, McCague K, Camacho A, Pina IL, Rocha RA, Shah AM, Williamson KM, Solomon SD; PROVE-HF Investigators. Association of Change in N-Terminal Pro-B-Type Natriuretic Peptide Following Initiation of Sacubitril-Valsartan Treatment With Cardiac Structure and Function in Patients With Heart Failure With Reduced Ejection Fraction. JAMA. 2019 Sep 17;322(11):1085-1095. doi: 10.1001/jama.2019.12821.
PubMed 31475295Wilcox JE, Fang JC, Margulies KB, Mann DL. Heart Failure With Recovered Left Ventricular Ejection Fraction: JACC Scientific Expert Panel. J Am Coll Cardiol. 2020 Aug 11;76(6):719-734. doi: 10.1016/j.jacc.2020.05.075.
PubMed 32762907Bak M, Park Y, Kim D, Shin H, Hong D, Yang JH, Choi JO. Angiotensin receptor blocker versus angiotensin receptor-neprilysin inhibitor in improved HF with stabilized NT-proBNP levels. Rev Esp Cardiol (Engl Ed). 2026 Jun;79(6):545-556. doi: 10.1016/j.rec.2025.12.006. Epub 2025 Dec 11. English, Spanish.
PubMed 41390047
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Comparison of Sacubitril/Valsartan Versus Valsartan on the Outcome of Heart Failure With Improved Ejection Fraction: a Pilot Study
- ClinicalTrials.gov ID
- NCT04803175
- Acronym / sponsor ID
- PROSPER-HF / 2020-08-082
- Conditions
- Heart Failure, Systolic
- Keywords
- Heart Failure with reduced Ejection Fraction, Heart Failure with improved Ejection Fraction, Sacubitril/valsartan, Valsartan
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 16 Mar 2021 (actual)
- Primary completion
- Feb 2024 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 17 Mar 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.
Heart failure (HF) is a chronic disease with weakened heart muscles or abnormal pressure within the heart chambers result in breathlessness, leg edema, or fatigue. A subclass of HF shows reduced heart muscle contractility, which is represented by the left ventricular ejection fraction (LVEF). Valsartan is an angiotensin II receptor blocker, a major drug class for heart failure. Sacubitril/valsartan is a combination of 2 drugs, classified as a new class of drug called angiotensin receptor neprilysin inhibitor (ARNI). Although these medications are both first-line treatment in HF with reduced LVEF, recent guidelines encourage the use of sacubitril/valsartan in patients with ongoing symptoms. After successful treatment, some patients experience recovery of LVEF. In these patients, otherwise called heart failure with improved ejection fraction (HFiEF), it is not clear whether continued treatment with sacubitril/valsartan or valsartan is beneficial in terms of relapse of heart failure or worsening of LVEF. Therefore, the investigators aim to determine whether the treatment with sacubitril/valsartan versus valsartan differs in clinical outcomes after 1 year in HFiEF patients by observing the change in blood test markers of heart failure (N-terminal prohormone of brain natriuretic peptide; NT-proBNP) and aggravation of HF defined as reduced LVEF, congestive symptoms, hospitalization or death from HF.
Detailed description
- Background and study purpose Heart failure (HF) is caused by structural or functional abnormality of the myocardium or elevated intracardiac pressures, resulting in symptoms and signs of low cardiac output or congestion, such as dyspnea, peripheral edema, elevated jugular venous pressures, pulmonary congestion, and fatigue. HF with reduced left ventricular ejection fraction (HFrEF) is defined as an LVEF <40% by the 2013 American College of Cardiology/American Heart Association (ACC/AHA) guidelines. Recent guidelines recommend the use of angiotensin-converting enzyme inhibitors (ACEI)/angiotensin II receptor blocker (ARB)/angiotensin receptor neprilysin inhibitor (ARNI), beta blockers (BB), aldosterone antagonists (AA), and sodium-glucose co-transporter-2 inhibitors (SGLT2i) in HFrEF patients. ACEI/ARB/ARNI, collectively known as renin-angiotensin-system (RAS) blockers, are considered the most important drug class in the treatment for HFrEF and recently, ARNI is increasingly preferred as the first-choice drug. Unlike for initial treatment of HFrEF, continued treatment for patients who experience recovery of LVEF is not as well established. In these patients, called heart failure with improved ejection fraction (HFiEF), it is not clear whether continued treatment with sacubitril/valsartan or valsartan is beneficial in terms of relapse of heart failure or worsening of LVEF. Therefore, the investigators aim to determine whether the treatment with sacubitril/valsartan versus valsartan differs in clinical outcomes after 1 year in HFiEF patients by observing the change in serum N-terminal prohormone of brain natriuretic peptide (NT-proBNP) and clinical relapse of HF.
- Registry factors
- Source data verification will be done by comparing the data to electronic medical records and paper and electronic case report forms.
- Data dictionary with detailed description of each variables are given.
- Sample size assessment was calculated by comparing mean NT-proBNP levels at baseline and after 12 months in the two groups by two-sample t-test (two-sided, effect size=0.6, type I error=0.05, type II error=0.8, allocation ratio=1). With a drop-out rate of 10%, 50 patients in each group are needed. As the change of NT-proBNP in HFiEF with sacubitril/valsartan or valsartan has rarely been reported, estimation from the TRED-HF study (Lancet. 2019 Jan 5; 393(10166):61) was used as reference for effect size. This reference was a small study of 25 patients in each group. Therefore, the effect size used for calculation was modified to 0.6 rather than 0.8 by intuition of the investigators.
- Plan for missing data: To avoid unavailable data, clinical visits will be monitored and calls will be made for missed appointments. Uninterpretable or out-of-range results will be discussed by participating investigators through regular meetings.
- Statistical analysis Based on intention-to-treat analysis, the primary outcome (NT-proBNP changes) will be log-transformed and compared by paired t-tests. Baseline characteristics will be presented according to initial drug assignment and compared with the Mann-Whitney test for continuous variables or Fisher's exact test for categorical variables. Data are presented as median and IQR or as n (%). Occurrence of the secondary endpoint will be graphically displayed per group with Kaplan-Meier survival plots and compared with the log-rank test. Cox proportional hazards models will be used to investigate predictors of worsening NT-proBNP levels or occurrence of clinical adverse events in patients of each group. A p value less than 0.05 will be considered significant.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sacubitril/valsartan | – | Drug: Sacubitril-ValsartanPatients undergoing continued treatment with sacubitril/valsartan after improvement of LVEF >40% with > 3 months of sacubitril/valsartan treatment. Dose and titration schedule will be individualized by discretion of the attending physician. |
| Valsartan | – | Drug: ValsartanPatients undergoing continued treatment with valsartan after improvement of LVEF >40% with > 3 months of sacubitril/valsartan treatment. Dose and titration schedule will be individualized by discretion of the attending physician. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 1. Consecutive participant sampling was done for all eligible patients. 2. Patients visiting a specialized heart failure clinic at one of the top tertiary level hospitals in Seoul, Korea. Patients have a nationwide distribution geographically, and show a wide range of clinical presentations.
Key inclusion criteria (3 listed)
- Patient with a history of HF with reduced EF (HFrEF; LVEF <40 percent) and received treatment with sacubitril/valsartan for at least 3 months, after which showing improvement of LVEF to >40 percent and symptoms of NYHA functional class I or II
- serum NT-proBNP levels < 400 pg/dL for sinus rhythm and < 600pg/dL for atrial fibrillation
- Patients on stable doses of diuretics for 1 week
Key exclusion criteria (8 listed)
- History of hospitalization for heart failure within 30 days before enrollment
- History of acute coronary syndrome (acute myocardial infarction or unstable angina), percutaneous coronary artery intervention or cardiac surgery within 30 days before enrollment
- History of cardiac resynchronization therapy within 90 days before screening
- Planned percutaneous or surgical coronary artery revascularization, or major cardiac surgery (coronary artery bypass, valvuloplasty, mechanical cardiac support or heart transplantation) within 90 days after enrollment
- Contraindicated or has history of hypersensitivity to RAS blockers including ACEI or ARB
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-ValsartanAlso: EntrestoParticipants will receive individualized dosage and titration as part of routine medical care, and a the effect will be studied for at least 12 months. The investigator does not assign specific interventions to the study participants. | Drug | Sacubitril/valsartan |
| ValsartanAlso: DiovanParticipants will receive individualized dosage and titration as part of routine medical care, and a the effect will be studied for at least 12 months. The investigator does not assign specific interventions to the study participants. | Drug | Valsartan |
Primary outcome
Change in NT-proBNP concentration
Time frame: Baseline, 6 months, 12 months
pg/ml
4 secondary outcomes
Heart failure relapse
Time frame: 6 months and 12 months
Hospitalization for heart failure (HHF)
Time frame: 6 months and 12 months
Death caused by heart failure
Time frame: 6 months and 12 months
Mortality
Time frame: 6 months and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2021.
- Background: PubMed 30429050Halliday BP, Wassall R, Lota AS, Khalique Z, Gregson J, Newsome S, Jackson R, Rahneva T, Wage R, Smith G, Venneri L, Tayal U, Auger D, Midwinter W, Whiffin N, Rajani R, Dungu JN, Pantazis A, Cook SA, Ware JS, Baksi AJ, Pennell DJ, Rosen SD, Cowie MR, Cleland JGF, Prasad SK. Withdrawal of pharmacological treatment for heart failure in patients with recovered dilated cardiomyopathy (TRED-HF): an open-label, pilot, randomised trial. Lancet. 2019 Jan 5;393(10166):61-73. doi: 10.1016/S0140-6736(18)32484-X. Epub 2018 Nov 11.
- Background: PubMed 31475295Januzzi JL Jr, Prescott MF, Butler J, Felker GM, Maisel AS, McCague K, Camacho A, Pina IL, Rocha RA, Shah AM, Williamson KM, Solomon SD; PROVE-HF Investigators. Association of Change in N-Terminal Pro-B-Type Natriuretic Peptide Following Initiation of Sacubitril-Valsartan Treatment With Cardiac Structure and Function in Patients With Heart Failure With Reduced Ejection Fraction. JAMA. 2019 Sep 17;322(11):1085-1095. doi: 10.1001/jama.2019.12821.
- Background: PubMed 32762907Wilcox JE, Fang JC, Margulies KB, Mann DL. Heart Failure With Recovered Left Ventricular Ejection Fraction: JACC Scientific Expert Panel. J Am Coll Cardiol. 2020 Aug 11;76(6):719-734. doi: 10.1016/j.jacc.2020.05.075.
- Derived from this study: PubMed 41390047Bak M, Park Y, Kim D, Shin H, Hong D, Yang JH, Choi JO. Angiotensin receptor blocker versus angiotensin receptor-neprilysin inhibitor in improved HF with stabilized NT-proBNP levels. Rev Esp Cardiol (Engl Ed). 2026 Jun;79(6):545-556. doi: 10.1016/j.rec.2025.12.006. Epub 2025 Dec 11. English, Spanish.
- Individual participant dataSharing planned: Undecided. The access criteria has not been discussed yet.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, Systolic, run by Samsung Medical Center at 1 site in South Korea.
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 3 inclusion and 8 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 18 Aug 2021. 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 South Korea. 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.
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?
Contact Jinoh Choi, MD, PhD (82234103417, choijean5@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in NT-proBNP concentration (time frame: Baseline, 6 months, 12 months). 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 NCT04803175, which also lists 4 linked publications.
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 18 Aug 2021; AzTrials last refreshed its copy on 6 Nov 2026.