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Cardiopulmonary Exercise Testing-based High-intensity Interval Training For Improving Heart Failure With Preserved Ejection Fraction (CPHIT-HFpEF)

12 de julho de 2026 atualizado por: Tang Yida, Peking University Third Hospital

Cardiovascular-Kidney-Metabolic (CKM) Syndrome is a continuous clinical disease spectrum integrating cardiovascular, renal, and metabolic disorders. Heart failure with preserved ejection fraction (HFpEF) is considered Stage 4 of CKM syndrome, characterized primarily by impairment of cardiac structure and function. Numerous studies have confirmed that exercise intervention is effective in improving metabolic profiles and inflammatory status in Stages 0-3 of CKM syndrome (e.g., obesity, metabolic syndrome, hypertension, and diabetes), and significantly improves clinical outcomes. However, for Stage 4 CKM syndrome, especially in patients with HFpEF, conventional exercise prescription faces significant challenges in balancing safety and efficacy. Moreover, traditional "one-size-fits-all" exercise rehabilitation strategies have failed to significantly improve clinical outcomes due to the lack of individualized precision approaches.

To address this gap, this study proposes to adopt a multicenter, randomized, controlled design, enrolling patients with HFpEF at Stage 4 of CKM syndrome and randomly assigning them to either a personalized high-intensity interval training (HIIT) intervention group or a standard care control group. The **primary endpoint** of this study is the change in peak oxygen consumption (peak VO₂) from baseline after 24 weeks of intervention. In addition, a series of **secondary endpoints** have been established for comprehensive evaluation, including inflammatory biomarkers, cardiac structure and function, quality of life, and composite clinical events. These endpoints aim to comprehensively assess the intervention effects from the perspectives of cardiopulmonary function, metabolism and inflammation, quality of life, and clinical outcomes, as well as to explore the underlying mechanisms.

This study is expected to validate the beneficial effects of personalized exercise on peak VO₂ and various secondary endpoints in patients with Stage 4 CKM syndrome. It will not only provide high-level evidence-based support for exercise therapy in HFpEF but also deepen the understanding of the role of exercise intervention in the full-course management of CKM syndrome, offering key scientific support for the development of precision prevention and treatment strategies across all stages.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Estimado)

192

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

  • China
      • Beijing, China
        • Peking University First Hospital
        • Investigador principal:
          • Jianping Li
      • Beijing, China
        • Peking University Third Hospital
        • Contato:
      • Beijing, China
        • Beijing Hospital
        • Investigador principal:
          • Fang Wang
      • Beijing, China
        • Peking University People's Hospital
        • Investigador principal:
          • Jian Liu
      • Beijing, China
        • Beijing Chao-Yang Hospital, Capital Medical University
        • Investigador principal:
          • Yuanhua Yang
      • Beijing, China
        • Beijing Zhongguancun Hospital
        • Investigador principal:
          • Chaoyi Zhang
      • Beijing, China
        • Beijing Xiaotangshan Hospital
        • Investigador principal:
          • Rong Guo
      • Beijing, China
        • Community Health Station of the Party School of the Central Committee of C.P.C
        • Investigador principal:
          • Wei Zhao
      • Beijing, China
        • Jimenli Community Health Service Center
        • Investigador principal:
          • Qiue Zhang
      • Beijing, China
        • Xueyuanlu Community Health Service Center
        • Investigador principal:
          • Hongyun Chi
      • Shanghai, China
        • Shanghai East Hospital
        • Investigador principal:
          • Ying Li
      • Wuhan, China
        • Wuhan Asia Heart Hospital
        • Investigador principal:
          • Yin Li

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

Inclusion Criteria:

  1. Men and women aged 35-70 years;

  2. Physical inactivity / sedentary lifestyle defined as:

    Sedentary behavior: average daily sitting time > 6 hours over the past 6 months; AND/OR Insufficient physical activity: average weekly moderate-intensity physical activity < 150 minutes or vigorous-intensity physical activity < 75 minutes as assessed by the International Physical Activity Questionnaire (IPAQ);

  3. Patients with HFpEF at Stage 4 of CKM syndrome who have been clinically stable within the past month (New York Heart Association [NYHA] functional class II-III);
  4. Willingness to improve health status through appropriate exercise.

Exclusion Criteria:

  1. Presence of contraindications to cardiopulmonary exercise testing (CPET);
  2. Positive findings on the exercise electrocardiogram (ECG) during CPET;
  3. Diagnosis of psychiatric disorders;
  4. Presence of movement disorders or lower extremity exercise-related injuries within the past 6 months;
  5. Women who are pregnant, breastfeeding, or planning to become pregnant in the near future;
  6. Other conditions deemed unsuitable for participation in this study by the investigators;
  7. Refusal to sign the informed consent form.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: HIIT intervention group
Subjects in the intervention group will undergo a 24-week personalized high-intensity interval training (HIIT) program, four times per week, with the exercise protocol tailored based on cardiopulmonary exercise testing (CPET). In addition, they will receive guideline-directed healthy lifestyle recommendations and optimal medical therapy (GDMT)
Comportamental: High-intensity interval training
Subjects in the intervention group will receive a personalized high-intensity interval training (HIIT) protocol based on cardiopulmonary exercise testing (CPET) and will undergo a 24-week HIIT intervention, four times per week.The exercise protocol consisted of a 5-minute warm-up at 30-40 watts, followed by 8 cycles of high-intensity exercise performed at 80-90% of peak VO₂ for 30 seconds, each interspersed with a 60-second active recovery period of low-intensity exercise at 50-60% of peak VO₂ , and concluded with a 5-minute cool-down at 30-40 watts.
Sem intervenção: Standard care control group
Control group subjects will receive guideline-directed optimal medical therapy (GDMT) , identical to that provided to the intervention group. In addition, they will receive a single, standardized health education session focused on HFpEF and obesity management, covering general recommendations regarding diet, weight management, and regular physical activity. No structured or supervised exercise prescription or program will be offered to the control group.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Peak VO2
Prazo: Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
Peak VO2 is assessed through CPET, using a maximal graded treadmill test based on the Chinese expert consensus on the standardized clinical application of CPET.
Baseline（week 0），Mid-term（week 12），End of study（week 24 ）

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Blood specimen
Prazo: Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
Lab tests include cytokines
Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
Blood specimen
Prazo: Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
Lab tests include high-sensitivity C-reactive protein (hs-CRP)
Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
Blood specimen
Prazo: Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
Lab tests include N-terminal pro-B-type natriuretic peptide (NT-proBNP)
Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
Kansas City Cardiomyopathy Questionnaire (KCCQ)
Prazo: Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a 23-item, self-administered, disease-specific instrument that assesses physical limitations, symptoms (frequency, severity, and change), self-efficacy, social function, and quality of life in patients with heart failure. It has demonstrated high reliability and validity. Scores are transformed to a range of 0 to 100, with higher scores reflecting better health-related quality of life.
Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
The New York Heart Association (NYHA) Functional Classification
Prazo: Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
The New York Heart Association (NYHA) Functional Classification is a commonly used tool by clinicians to quantify the severity of symptoms and physical activity limitations in patients with heart failure. The classification places patients into one of four categories: Class I (no limitation of physical activity), Class II (slight limitation, ordinary activity causes symptoms), Class III (marked limitation, less than ordinary activity causes symptoms), and Class IV (unable to carry on any physical activity without discomfort, symptoms may be present at rest).
Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
Montreal Cognitive Assessment (MoCA)
Prazo: Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
The Montreal Cognitive Assessment (MoCA) is a standardized 30-point screening tool used to detect cognitive impairment. It assesses multiple cognitive domains including visuospatial/executive function, naming, memory, attention, language, abstraction, delayed recall, and orientation. The test takes approximately 10 minutes to administer. Scores range from 0 to 30, with higher scores reflecting better cognitive function. A score of 26 or above is generally considered normal; 18-25 indicates mild cognitive impairment; 10-17 indicates moderate cognitive impairment; and below 10 indicates severe cognitive impairment. One point is added to the raw score for individuals with 12 or fewer years of education.
Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
Hospital Anxiety and Depression Scale (HADS)
Prazo: Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
The Hospital Anxiety and Depression Scale (HADS) is a 14-item, self-administered screening tool designed to assess symptoms of anxiety and depression. It comprises two independent subscales: anxiety (HADS-A) and depression (HADS-D), each containing 7 items. Each item is scored from 0 to 3, yielding a subscale total score ranging from 0 to 21, with higher scores indicating greater symptom severity. Based on established cutoffs, scores of 0-7 are considered normal, 8-10 indicate borderline abnormal (mild), and 11-21 indicate abnormal (moderate to severe).
Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
Pittsburgh Sleep Quality Index (PSQI)
Prazo: Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
The Pittsburgh Sleep Quality Index (PSQI) is a 19-item, self-rated questionnaire that assesses sleep quality over a 1-month time interval. It comprises seven component scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. Each component is scored from 0 to 3, and the sum of these seven components yields a global PSQI score ranging from 0 to 21, with higher scores indicating poorer sleep quality.
Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
International Physical Activity Questionnaire (IPAQ)
Prazo: Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
The International Physical Activity Questionnaire (IPAQ) Long Form is a 27-item, self-administered questionnaire that assesses physical activity over the past 7 days across five life domains: work-related activity, transportation-related activity, domestic and gardening activity, leisure-time activity, and sitting time. Metabolic equivalent (MET) values assigned are: walking = 3.3 METs, moderate-intensity activity = 4.0 METs, and vigorous-intensity activity = 8.0 METs. Activity volume for each domain is calculated as MET-minutes per week (MET-min/week) using the formula: MET value × days per week × minutes per day. Total physical activity is derived by summing MET-min/week across all domains. Based on total MET-min/week, participants are classified into three levels: low (< 600 MET-min/week), moderate (600-3000 MET-min/week), and high (≥ 3000 MET-min/week)
Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
Peak O₂ pulse
Prazo: Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
Peak O₂ pulse will be assessed by cardiopulmonary exercise testing (CPET) .
Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
Anaerobic Threshold (AT)
Prazo: Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
Anaerobic Threshold (AT) will be assessed by cardiopulmonary exercise testing (CPET) .
Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
VE/VCO₂ slope
Prazo: Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
VE/VCO₂ slope will be assessed by cardiopulmonary exercise testing (CPET) . Ventilation (VE) and carbon dioxide output (VCO₂) will be measured breath-by-breath throughout the test. The VE/VCO₂ slope will be calculated by linear regression analysis of VE versus VCO₂ using data from the beginning of exercise up to the respiratory compensation point (RCP).
Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
left atrial volume index (LAVI) assessed by echocardiography
Prazo: Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
Left atrial volume index (LAVI) will be assessed using echocardiography. LAVI is calculated as left atrial volume indexed to body surface area (BSA), and will be reported in mL/m².
Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
left atrial volume index (LAVI) assessed by cardiac magnetic resonance(CMR)
Prazo: Baseline（week 0），End of study（week 24 ）
Left atrial volume index (LAVI) will be measured by cardiac magnetic resonance(CMR). LAVI is calculated as left atrial volume indexed to body surface area (BSA) and reported in mL/m².
Baseline（week 0），End of study（week 24 ）
Left ventricular mass index (LVMI) assessed by echocardiography
Prazo: Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
Left ventricular mass index (LVMI) will be measured by echocardiography. LVMI is derived by indexing LVM to body surface area (BSA) and reported in g/m².
Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
Left ventricular mass index (LVMI) assessed by cardiac magnetic resonance(CMR)
Prazo: Baseline（week 0），End of study（week 24）
Left ventricular mass index (LVMI) will be measured by cardiac magnetic resonance(CMR). LVMI is derived by indexing LVM to body surface area (BSA) and reported in g/m².
Baseline（week 0），End of study（week 24）
left atrial volume (LAV)
Prazo: Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
Left atrial volume (LAV) will be assessed using echocardiography , and will be reported in mL.
Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
left atrial area (LAA)
Prazo: Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
Left atrial area (LAA) will be measured by echocardiography . Left atrial area index (LAAI) will be calculated as LAA max divided by body surface area (BSA) and reported in cm²/m².
Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
left atrial diameter (LAD)
Prazo: Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
Left atrial diameter (LAD) will be measured by echocardiography and reported in mm.
Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
Diastolic function index (E/e' ratio)
Prazo: Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
Diastolic function index (E/e' ratio) will be measured by echocardiography. The E/e' ratio is a noninvasive surrogate marker for estimating left ventricular filling pressure and is central to the grading of diastolic dysfunction.
Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
Global longitudinal strain (GLS)
Prazo: Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
Global longitudinal strain (GLS) will be measured by echocardiography and reported in %. GLS is expressed as a negative value, with more negative values indicating better left ventricular systolic function.
Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
Left ventricular myocardial work (MW)
Prazo: Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
Left ventricular myocardial work (MW) will be assessed by echocardiography and reported in mmHg%.
Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
Left atrial strain (LAS)
Prazo: Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
Left atrial strain (LAS) will be measured by echocardiography and reported in %.
Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
Epicardial adipose tissue volume (EATV)
Prazo: Baseline（week 0），End of study（week 24 ）
Epicardial adipose tissue volume (EATV) will be quantified using cardiac magnetic resonance (CMR) and reported in mL.
Baseline（week 0），End of study（week 24 ）
Pericardial adipose tissue volume
Prazo: Baseline（week 0），End of study（week 24 ）
Pericardial adipose tissue volume will be quantified using cardiac magnetic resonance (CMR) and reported in mL
Baseline（week 0），End of study（week 24 ）
Liver fat content (LFC)
Prazo: Baseline（week 0），End of study（week 24 ）
Liver fat content (LFC) will be quantified using magnetic resonance imaging-derived proton density fat fraction (MRI-PDFF) and expressed as a percentage (%)
Baseline（week 0），End of study（week 24 ）
Liver Stiffness Measurement（LSM）assessed by magnetic resonance elastography (MRE)
Prazo: Baseline（week 0），End of study（week 24 ）
Liver stiffness measurement (LSM) will be assessed by magnetic resonance elastography (MRE) and reported in kilopascals (kPa), with higher values indicating more severe liver fibrosis
Baseline（week 0），End of study（week 24 ）
Visceral adipose tissue area (VATA)
Prazo: Baseline（week 0），End of study（week 24 ）
Visceral adipose tissue area (VATA) will be measured using non-contrast chest CT and reported in cm²
Baseline（week 0），End of study（week 24 ）
BMI
Prazo: Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
Weight (kg) is measured with digital weighing scale. Height (cm) is measured with a portable stadiometer. BMI is calculated as weight in kilograms divided by the square of height in meters
Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
Waist-to-height ratio (WHtR)
Prazo: Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
Waist-to-height ratio (WHtR) will be calculated using standard anthropometric measurements. Waist circumference will be measured at the midpoint between the lower costal margin and the iliac crest at the mid-axillary line at the end of expiration. WHtR is calculated as waist circumference divided by height.
Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
Waist-to-hip ratio (WHR)
Prazo: Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
Waist-to-hip ratio (WHR) will be calculated using standard anthropometric measurements. Waist circumference will be measured at the midpoint between the lower costal margin and the iliac crest at the mid-axillary line at the end of expiration; hip circumference will be measured at the maximal gluteal protuberance. WHR as waist circumference divided by hip circumference.
Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
All-Cause Death
Prazo: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
All-cause death is defined as death from any cause occurring from baseline to the end of follow-up. Death information will be ascertained through regular follow-up, medical record review, and family reports. For participants lost to follow-up, vital status will be confirmed by cross-referencing with the local population death registry. This study will report the incidence of all-cause death from randomization to the end of study.
Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Heart failure rehospitalization
Prazo: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Heart failure rehospitalization is defined as an unplanned hospitalization (≥24 hours) due to decompensated heart failure, requiring at least one of the following intravenous therapies during the hospital stay: (1) intravenous diuretics; (2) intravenous vasodilators; or (3) intravenous inotropic agents. This study will report the incidence of heart failure rehospitalization from baseline to the end of the study.
Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Exercise intervention-related adverse events
Prazo: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Exercise intervention-related adverse events are defined as any adverse medical events occurring during participation in the exercise intervention protocol or within post-exercise, judged by the investigator to have a possible, probable, or definite causal relationship with the study exercise intervention. These include, but are not limited to, exercise-induced arrhythmias, angina, hypotensive/hypertensive crises, and musculoskeletal injuries requiring medical intervention. The overall incidence of exercise-related adverse events will be reported from baseline to the end of the study.
Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Clinical deterioration
Prazo: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Clinical deterioration is defined as any of the following events due to worsening heart failure that do not meet hospitalization criteria: (1) unscheduled clinic visit for worsening HF symptoms (dyspnea, edema, fatigue) requiring therapy intensification; (2) emergency department observation (<24 hours) for decompensated HF; (3) outpatient/day-care intravenous diuretics or vasodilators; or (4) significant upward titration of oral diuretics (e.g., dose doubling or new agent), confirmed by the investigator. Events progressing to hospitalization will be captured under "HF rehospitalization" and excluded here. Incidence will be reported as proportion of participants from baseline to the end of the study.
Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Blood specimen
Prazo: Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
Lab tests include adipokines
Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
Blood specimen
Prazo: Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
Lab tests include cardiac troponin
Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
Liver Stiffness Measurement（LSM）assessed by FibroTouch transient elastography
Prazo: Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
Liver stiffness measurement (LSM) will be assessed using the FibroTouch transient elastography system and reported in kilopascals (kPa).
Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
Fecal specimens
Prazo: Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
Fecal specimens will be collected at baseline and Week 24 for gut microbiome profiling.
Baseline（week 0），Mid-term（week 12），End of study（week 24 ）

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Peking University Third Hospital

Colaboradores

Beijing Municipal Health Commission
National Health Commission of the People's Republic of China

Investigadores

  • Cadeira de estudo: Yida Tang, MD,PhD, Peking University Third Hospital

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de julho de 2026

Conclusão Primária (Estimado)

1 de julho de 2027

Conclusão do estudo (Estimado)

30 de abril de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

21 de junho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

3 de julho de 2026

Primeira postagem (Real)

9 de julho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

14 de julho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

12 de julho de 2026

Última verificação

1 de julho de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • CPHIT-2
  • BRWEP2024W014090204 (Número de outro subsídio/financiamento: Beijing Municipal Health Commission)
  • 2025ZD0546100 (Número de outro subsídio/financiamento: National Health Commission of the People's Republic of China)
  • TY2025008 (Número de outro subsídio/financiamento: Peking University-Golden Resource"Tengyun Clinical Research Program")

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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