Acute Decompensated Heart FailureS-ADHFNCT06298825
S-ADHF：Sarcopenia in Patients With ADHF
An observational study of Acute Decompensated Heart Failure, run by Guangdong Provincial People's Hospital at 1 site in China.
Trial summary
This is a prospective, multi-center, investigator-initiated observational cohort study. Enrollment with a minimum of of 195 cases each for patients with and without sarcopenia. Each patient is followed up for 6 month, 1 year, 2 years or until the occurrence of death.This study will examine the correlation between… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Decompensated Heart Failure
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2024to 1 Jun 2026
- 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: Enrollment of up to 500 participants adults aged over 18 years hospitalized for ADHF is planned, with a minmum of of 195 cases each for patients with and without sarcopenia
Who may be able to join
- Age ≥18 years
- At least one symptom of heart failure upon admission:Dyspnea at rest or with exertion, orthopnea, paroxysmal nocturnal dyspnea or exertional fatigue.
- At least two of the signs of heart failure (HF):
- Distended jugular veins, enlarged cardiac silhouette, apex beat displacement, third heart sound, or increased jugular venous pressure/central venous pressure/pulmonary capillary wedge pressure.
- Pulmonary edema or pulmonary congestion (rales or chest X-ray/CT evidence of pulmonary congestion).
- Peripheral edema. Elevated B-type natriuretic peptide (>100 pg/ml) or elevated N-Terminal Pro-Brain Natriuretic Peptide (>300 pg/ml).
- Willingness to provide informed consent and cooperate with the follow-up
Who cannot join
- Unable to understand and comply with protocol or to give informed consent
- End-stage diseases other than heart failure, life expectancy <1 year, such as malignant tumors
- Current or planned participation in a clinical trial.
Trial locations and contacts
1 site in 1 country.
China1 site
Huan Ma
Guangdong
Huan Ma, PhD, +86 15078755932, mahuandoctor@163.com
About this study
Official title: Effect of Sarcopenia on Prognosis of Patients With Acute Decompensated Heart Failure: a Prospective, Multi-center, Observational Cohort Study
This is a prospective, multi-center, investigator-initiated observational cohort study. Enrollment with a minimum of of 195 cases each for patients with and without sarcopenia. Each patient is followed up for 6 month, 1 year, 2 years or until the occurrence of death.This study will examine the correlation between sarcopenia and prognosis in different subgroups of patients, and explore the additive effect of different comorbidities and sarcopenia on prognosis in patients with acute decompensated heart failure.
Read the detailed description
Guangdong Provincial People's Hospital will be the lead center, with an additional 4 hospitals designated as satellite centers for the study. Enrollment of up to 500 participants adults aged over 18 years hospitalized for ADHF is planned, with a minimum of of 195 cases each for patients with and without sarcopenia The sympathetic nervous activity, psychosocial factors, quality of life, physical function and baseline physical activity will also be observed and recorded at baseline. Each patient is followed up for 6 month, 1 year, 2 years or until the occurrence of death. The primary clinical outcome is all-cause mortality at 6 months. Other clinical outcomes of interest include cardiovascular mortality, all-cause hospitalisation, HF hospitalisation, the frequency and length of hospitalization of patient readmitted and survival time from enrollment to death of deceased patients.
This study will examine the correlation between sarcopenia and prognosis in different subgroups of patients, and explore the additive effect of different comorbidities and sarcopenia on prognosis in patients with acute decompensated heart failure. S-ADHF will provide important information and evidence on the clinical aspects of sarcopenia in patients with ADHF, and will potentially and contribute to accurate risk stratification and optimal clinical management for patient with ADHF.
- Conditions
- Acute Decompensated Heart Failure
- Keywords
- Acute decompensated heart failure, Sarcopenia, prognosis, mortality, Kansas City Cardiomyopathy Questionnaire (KCCQ)
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| sarcopenia | Acute decompensated heart failure with sarcopenia. Sarcopenia will be defined using the Asian Working Group for Sarcopenia (AWGS) criteria in the study. According to the guidelines, we can define participants as having sarcopenia when low muscle strength or physical performance coexisted with low skeletal muscle mass. We will define low muscle strength as handgrip strength <26kg for men and <18 kg for women, low physical performance as a walk speed of <1.0m/s for both sexes. We can use bioelectrical impedance analysis to measure the appendicular skeletal muscle mass. The appendicular skeletal muscle mass index (ASMI) is calculated as the sum of muscle mass in the extremities divided by the height squared (kg/m2). The cut-off values of <7.00 kg/m2 for men and <5.70 kg/m2 for women will be used. | |
| Non-sarcopenia | Acute decompensated heart failure without sarcopenia |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
Number of all-cause death 6 months from hospital discharge
Measured: 6 months
Secondary outcomes (4)
All-cause mortality
Number of all-cause death 1year and 2 years from hospital discharge
Measured: 1 year and 2 year
Cardiovascular mortality
Number of cardiovascular death 6 moths， 1year and 2 years from hospital discharge
Measured: 6 moths， 1year and 2 years
All-cause hospitalisation
Number of all-cause hospitalisation 6 moths， 1year and 2 years from hospital discharge
Measured: 6 moths， 1year and 2 years
HF hospitalisation
Number of HF hospitalisation 6 moths， 1year and 2 years from hospital discharge
Measured: 6 moths， 1year and 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2024
- Study start1 Apr 2024 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (43)Papers the sponsor has linked to this study.
- Other trials for Acute Decompensated Heart FailureStudies of the same condition, open and under way.
- More trials run by Guangdong Provincial People's HospitalThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huan Ma, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06298825
- Sponsor's protocol ID
- KY2024-148
- Acronym
- S-ADHF
- Status last verified
- Jan 2024
- First submitted
- 1 Mar 2024
- Last updated
- 12 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Savarese G, Lund LH. Global Public Health Burden of Heart Failure. Card Fail Rev. 2017 Apr;3(1):7-11. doi: 10.15420/cfr.2016:25:2.
PubMed 28785469Arrigo M, Jessup M, Mullens W, Reza N, Shah AM, Sliwa K, Mebazaa A. Acute heart failure. Nat Rev Dis Primers. 2020 Mar 5;6(1):16. doi: 10.1038/s41572-020-0151-7.
PubMed 32139695Coles AH, Tisminetzky M, Yarzebski J, Lessard D, Gore JM, Darling CE, Goldberg RJ. Magnitude of and Prognostic Factors Associated With 1-Year Mortality After Hospital Discharge for Acute Decompensated Heart Failure Based on Ejection Fraction Findings. J Am Heart Assoc. 2015 Dec 23;4(12):e002303. doi: 10.1161/JAHA.115.002303.
PubMed 26702084Di Tano G, De Maria R, Gonzini L, Aspromonte N, Di Lenarda A, Feola M, Marini M, Milli M, Misuraca G, Mortara A, Oliva F, Pulignano G, Russo G, Senni M, Tavazzi L; IN-HF Outcome Investigators. The 30-day metric in acute heart failure revisited: data from IN-HF Outcome, an Italian nationwide cardiology registry. Eur J Heart Fail. 2015 Oct;17(10):1032-41. doi: 10.1002/ejhf.290. Epub 2015 May 27.
PubMed 26018852Wang H, Chai K, Du M, Wang S, Cai JP, Li Y, Zeng P, Zhu W, Zhan S, Yang J. Prevalence and Incidence of Heart Failure Among Urban Patients in China: A National Population-Based Analysis. Circ Heart Fail. 2021 Oct;14(10):e008406. doi: 10.1161/CIRCHEARTFAILURE.121.008406. Epub 2021 Aug 28.
PubMed 34455858McLean RR, Kiel DP. Developing consensus criteria for sarcopenia: an update. J Bone Miner Res. 2015 Apr;30(4):588-92. doi: 10.1002/jbmr.2492.
PubMed 25735999Kalafateli M, Mantzoukis K, Choi Yau Y, Mohammad AO, Arora S, Rodrigues S, de Vos M, Papadimitriou K, Thorburn D, O'Beirne J, Patch D, Pinzani M, Morgan MY, Agarwal B, Yu D, Burroughs AK, Tsochatzis EA. Malnutrition and sarcopenia predict post-liver transplantation outcomes independently of the Model for End-stage Liver Disease score. J Cachexia Sarcopenia Muscle. 2017 Feb;8(1):113-121. doi: 10.1002/jcsm.12095. Epub 2016 Feb 1.
PubMed 27239424Chen R, Xu J, Wang Y, Jiang B, Xu X, Lan Y, Wang J, Lin X. Prevalence of sarcopenia and its association with clinical outcomes in heart failure: An updated meta-analysis and systematic review. Clin Cardiol. 2023 Mar;46(3):260-268. doi: 10.1002/clc.23970. Epub 2023 Jan 16.
PubMed 36644878von Haehling S, Garfias Macedo T, Valentova M, Anker MS, Ebner N, Bekfani T, Haarmann H, Schefold JC, Lainscak M, Cleland JGF, Doehner W, Hasenfuss G, Anker SD. Muscle wasting as an independent predictor of survival in patients with chronic heart failure. J Cachexia Sarcopenia Muscle. 2020 Oct;11(5):1242-1249. doi: 10.1002/jcsm.12603. Epub 2020 Aug 6.
PubMed 32767518Curcio F, Testa G, Liguori I, Papillo M, Flocco V, Panicara V, Galizia G, Della-Morte D, Gargiulo G, Cacciatore F, Bonaduce D, Landi F, Abete P. Sarcopenia and Heart Failure. Nutrients. 2020 Jan 14;12(1):211. doi: 10.3390/nu12010211.
PubMed 31947528Yin J, Lu X, Qian Z, Xu W, Zhou X. New insights into the pathogenesis and treatment of sarcopenia in chronic heart failure. Theranostics. 2019 May 31;9(14):4019-4029. doi: 10.7150/thno.33000. eCollection 2019.
PubMed 31281529Eschalier R, Massoullie G, Boirie Y, Blanquet M, Mulliez A, Tartiere PL, Anker S, D'Agrosa Boiteux MC, Richard R, Jean F, Combaret N, Souteyrand G, Riocreux C, Pereira B, Motreff P, Stolt P, Rossignol P, Clerfond G. Sarcopenia in patients after an episode of acute decompensated heart failure: An underdiagnosed problem with serious impact. Clin Nutr. 2021 Jun;40(6):4490-4499. doi: 10.1016/j.clnu.2020.12.033. Epub 2021 Jan 9.
PubMed 33483182Matsumura K, Teranaka W, Matsumoto H, Fujii K, Tsujimoto S, Otagaki M, Morishita S, Hashimoto K, Shibutani H, Yamamoto Y, Shiojima I. Loss of skeletal muscle mass predicts cardiac death in heart failure with a preserved ejection fraction but not heart failure with a reduced ejection fraction. ESC Heart Fail. 2020 Dec;7(6):4100-4107. doi: 10.1002/ehf2.13021. Epub 2020 Sep 23.
PubMed 32964678Lopez PD, Nepal P, Akinlonu A, Nekkalapudi D, Kim K, Cativo EH, Visco F, Mushiyev S, Pekler G. Low Skeletal Muscle Mass Independently Predicts Mortality in Patients with Chronic Heart Failure after an Acute Hospitalization. Cardiology. 2019;142(1):28-36. doi: 10.1159/000496460. Epub 2019 Mar 20.
PubMed 30893691Liu C, Cheng KY, Tong X, Cheung WH, Chow SK, Law SW, Wong RMY. The role of obesity in sarcopenia and the optimal body composition to prevent against sarcopenia and obesity. Front Endocrinol (Lausanne). 2023 Mar 1;14:1077255. doi: 10.3389/fendo.2023.1077255. eCollection 2023.
PubMed 36936175
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sarcopenia on Prognosis of Patients With Acute Decompensated Heart Failure: a Prospective, Multi-center, Observational Cohort Study
- ClinicalTrials.gov ID
- NCT06298825
- Acronym / sponsor ID
- S-ADHF / KY2024-148
- Conditions
- Acute Decompensated Heart Failure
- Keywords
- Acute decompensated heart failure, Sarcopenia, prognosis, mortality, Kansas City Cardiomyopathy Questionnaire (KCCQ)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 7 Mar 2024 (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.
This is a prospective, multi-center, investigator-initiated observational cohort study. Enrollment with a minimum of of 195 cases each for patients with and without sarcopenia. Each patient is followed up for 6 month, 1 year, 2 years or until the occurrence of death.This study will examine the correlation between sarcopenia and prognosis in different subgroups of patients, and explore the additive effect of different comorbidities and sarcopenia on prognosis in patients with acute decompensated heart failure.
Detailed description
Guangdong Provincial People's Hospital will be the lead center, with an additional 4 hospitals designated as satellite centers for the study. Enrollment of up to 500 participants adults aged over 18 years hospitalized for ADHF is planned, with a minimum of of 195 cases each for patients with and without sarcopenia The sympathetic nervous activity, psychosocial factors, quality of life, physical function and baseline physical activity will also be observed and recorded at baseline. Each patient is followed up for 6 month, 1 year, 2 years or until the occurrence of death. The primary clinical outcome is all-cause mortality at 6 months. Other clinical outcomes of interest include cardiovascular mortality, all-cause hospitalisation, HF hospitalisation, the frequency and length of hospitalization of patient readmitted and survival time from enrollment to death of deceased patients.
This study will examine the correlation between sarcopenia and prognosis in different subgroups of patients, and explore the additive effect of different comorbidities and sarcopenia on prognosis in patients with acute decompensated heart failure. S-ADHF will provide important information and evidence on the clinical aspects of sarcopenia in patients with ADHF, and will potentially and contribute to accurate risk stratification and optimal clinical management for patient with ADHF.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sarcopenia | – | –Acute decompensated heart failure with sarcopenia. Sarcopenia will be defined using the Asian Working Group for Sarcopenia (AWGS) criteria in the study. According to the guidelines, we can define participants as having sarcopenia when low muscle strength or physical performance coexisted with low skeletal muscle mass. We will define low muscle strength as handgrip strength <26kg for men and <18 kg for women, low physical performance as a walk speed of <1.0m/s for both sexes. We can use bioelectrical impedance analysis to measure the appendicular skeletal muscle mass. The appendicular skeletal muscle mass index (ASMI) is calculated as the sum of muscle mass in the extremities divided by the height squared (kg/m2). The cut-off values of <7.00 kg/m2 for men and <5.70 kg/m2 for women will be used. |
| Non-sarcopenia | – | –Acute decompensated heart failure without sarcopenia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Enrollment of up to 500 participants adults aged over 18 years hospitalized for ADHF is planned, with a minmum of of 195 cases each for patients with and without sarcopenia
Key inclusion criteria (7 listed)
- Age ≥18 years
- At least one symptom of heart failure upon admission:Dyspnea at rest or with exertion, orthopnea, paroxysmal nocturnal dyspnea or exertional fatigue.
- At least two of the signs of heart failure (HF):
- Distended jugular veins, enlarged cardiac silhouette, apex beat displacement, third heart sound, or increased jugular venous pressure/central venous pressure/pulmonary capillary wedge pressure.
- Pulmonary edema or pulmonary congestion (rales or chest X-ray/CT evidence of pulmonary congestion).
Key exclusion criteria (3 listed)
- Unable to understand and comply with protocol or to give informed consent
- End-stage diseases other than heart failure, life expectancy <1 year, such as malignant tumors
- Current or planned participation in a clinical trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
All-cause mortality
Time frame: 6 months
Number of all-cause death 6 months from hospital discharge
4 secondary outcomes
All-cause mortality
Time frame: 1 year and 2 year
Cardiovascular mortality
Time frame: 6 moths， 1year and 2 years
All-cause hospitalisation
Time frame: 6 moths， 1year and 2 years
HF hospitalisation
Time frame: 6 moths， 1year and 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Background: PubMed 28785469Savarese G, Lund LH. Global Public Health Burden of Heart Failure. Card Fail Rev. 2017 Apr;3(1):7-11. doi: 10.15420/cfr.2016:25:2.
- Background: PubMed 32139695Arrigo M, Jessup M, Mullens W, Reza N, Shah AM, Sliwa K, Mebazaa A. Acute heart failure. Nat Rev Dis Primers. 2020 Mar 5;6(1):16. doi: 10.1038/s41572-020-0151-7.
- Background: PubMed 26702084Coles AH, Tisminetzky M, Yarzebski J, Lessard D, Gore JM, Darling CE, Goldberg RJ. Magnitude of and Prognostic Factors Associated With 1-Year Mortality After Hospital Discharge for Acute Decompensated Heart Failure Based on Ejection Fraction Findings. J Am Heart Assoc. 2015 Dec 23;4(12):e002303. doi: 10.1161/JAHA.115.002303.
- Background: PubMed 26018852Di Tano G, De Maria R, Gonzini L, Aspromonte N, Di Lenarda A, Feola M, Marini M, Milli M, Misuraca G, Mortara A, Oliva F, Pulignano G, Russo G, Senni M, Tavazzi L; IN-HF Outcome Investigators. The 30-day metric in acute heart failure revisited: data from IN-HF Outcome, an Italian nationwide cardiology registry. Eur J Heart Fail. 2015 Oct;17(10):1032-41. doi: 10.1002/ejhf.290. Epub 2015 May 27.
- Background: PubMed 34455858Wang H, Chai K, Du M, Wang S, Cai JP, Li Y, Zeng P, Zhu W, Zhan S, Yang J. Prevalence and Incidence of Heart Failure Among Urban Patients in China: A National Population-Based Analysis. Circ Heart Fail. 2021 Oct;14(10):e008406. doi: 10.1161/CIRCHEARTFAILURE.121.008406. Epub 2021 Aug 28.
- Background: PubMed 25735999McLean RR, Kiel DP. Developing consensus criteria for sarcopenia: an update. J Bone Miner Res. 2015 Apr;30(4):588-92. doi: 10.1002/jbmr.2492.
- Background: PubMed 27239424Kalafateli M, Mantzoukis K, Choi Yau Y, Mohammad AO, Arora S, Rodrigues S, de Vos M, Papadimitriou K, Thorburn D, O'Beirne J, Patch D, Pinzani M, Morgan MY, Agarwal B, Yu D, Burroughs AK, Tsochatzis EA. Malnutrition and sarcopenia predict post-liver transplantation outcomes independently of the Model for End-stage Liver Disease score. J Cachexia Sarcopenia Muscle. 2017 Feb;8(1):113-121. doi: 10.1002/jcsm.12095. Epub 2016 Feb 1.
- Background: PubMed 36644878Chen R, Xu J, Wang Y, Jiang B, Xu X, Lan Y, Wang J, Lin X. Prevalence of sarcopenia and its association with clinical outcomes in heart failure: An updated meta-analysis and systematic review. Clin Cardiol. 2023 Mar;46(3):260-268. doi: 10.1002/clc.23970. Epub 2023 Jan 16.
- Background: PubMed 32767518von Haehling S, Garfias Macedo T, Valentova M, Anker MS, Ebner N, Bekfani T, Haarmann H, Schefold JC, Lainscak M, Cleland JGF, Doehner W, Hasenfuss G, Anker SD. Muscle wasting as an independent predictor of survival in patients with chronic heart failure. J Cachexia Sarcopenia Muscle. 2020 Oct;11(5):1242-1249. doi: 10.1002/jcsm.12603. Epub 2020 Aug 6.
- Background: PubMed 31947528Curcio F, Testa G, Liguori I, Papillo M, Flocco V, Panicara V, Galizia G, Della-Morte D, Gargiulo G, Cacciatore F, Bonaduce D, Landi F, Abete P. Sarcopenia and Heart Failure. Nutrients. 2020 Jan 14;12(1):211. doi: 10.3390/nu12010211.
- Background: PubMed 31281529Yin J, Lu X, Qian Z, Xu W, Zhou X. New insights into the pathogenesis and treatment of sarcopenia in chronic heart failure. Theranostics. 2019 May 31;9(14):4019-4029. doi: 10.7150/thno.33000. eCollection 2019.
- Background: PubMed 33483182Eschalier R, Massoullie G, Boirie Y, Blanquet M, Mulliez A, Tartiere PL, Anker S, D'Agrosa Boiteux MC, Richard R, Jean F, Combaret N, Souteyrand G, Riocreux C, Pereira B, Motreff P, Stolt P, Rossignol P, Clerfond G. Sarcopenia in patients after an episode of acute decompensated heart failure: An underdiagnosed problem with serious impact. Clin Nutr. 2021 Jun;40(6):4490-4499. doi: 10.1016/j.clnu.2020.12.033. Epub 2021 Jan 9.
- Individual participant dataSharing planned: No
Related trials for Acute Decompensated Heart Failure
Recruiting
Low Level Tragus Stimulation in Acute Decompensated Heart Failure
Acute Decompensated Heart Failure
Recruiting
Fluid Management of Acute Decompensated Heart Failure Subjects Treated With Reprieve System (FASTR-II) (IDE-G210258)
Acute Decompensated Heart Failure
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
RecruitingObservational study
Clinical Evaluation of NIRSense Tissue Oximetry Sensor Monitoring to Early Detect Cardiogenic Shock
Cardiogenic Shock, Acute Myocardial Infarction
RecruitingPhase 3
A Study to Determine the Efficacy and Safety of Finerenone on Morbidity and Mortality Among Hospitalized Heart Failure Patients
Heart Failure, Acute Heart Failure
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 Acute Decompensated Heart Failure, run by Guangdong Provincial People's Hospital 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 7 inclusion and 3 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 Mar 2024. 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.
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 Huan Ma, PhD (+86 15078755932, mahuandoctor@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality (time frame: 6 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 NCT06298825, which also lists 43 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 12 Mar 2024.