HFpEF - Heart Failure With Preserved Ejection FractionCPHIT-HFpEFNCT07693049
Cardiopulmonary Exercise Testing-based High-intensity Interval Training For Improving Heart Failure With Preserved Ejection Fraction
A study testing High-intensity interval training in people with HFpEF - Heart Failure With Preserved Ejection Fraction, run by Peking University Third Hospital at 13 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 35 to 70 years
- Conditions the study is for
- HFpEF - Heart Failure With Preserved Ejection Fraction
- What is being tested?
- High-intensity interval training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 13 sitesChina
- Study dates
- 10 Aug 2026to 30 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 35 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women aged 35-70 years;
- 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);
- 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);
- Willingness to improve health status through appropriate exercise.
Who cannot join
- Presence of contraindications to cardiopulmonary exercise testing (CPET);
- Positive findings on the exercise electrocardiogram (ECG) during CPET;
- Diagnosis of psychiatric disorders;
- Presence of movement disorders or lower extremity exercise-related injuries within the past 6 months;
- Women who are pregnant, breastfeeding, or planning to become pregnant in the near future;
- Other conditions deemed unsuitable for participation in this study by the investigators;
- Refusal to sign the informed consent form.
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
13 sites in 1 country
China13 sites, 13 recruiting
- Not yet recruiting
Beijing Chao-Yang Hospital, Capital Medical University
Beijing
Yuanhua Yang
- Not yet recruiting
Beijing Hospital
Beijing
Qian Zhang
- Not yet recruiting
Beijing Xiaotangshan Hospital
Beijing
Rong Guo
- Not yet recruiting
Beijing Zhongguancun Hospital
Beijing
Chaoyi Zhang
- Not yet recruiting
Community Health Station of the Party School of the Central Committee of C.P.C
Beijing
Wei Zhao
- Not yet recruiting
Jimenli Community Health Service Center
Beijing
Qiue Zhang
- Not yet recruiting
Peking University First Hospital
Beijing
Jianping Li
- Not yet recruiting
Peking University People's Hospital
Beijing
Jian Liu
- Recruiting
Peking University Third Hospital
Beijing
Yida Tang, 010-82265996, tangyida@bjmu.edu.cn
- Not yet recruiting
Xueyuanlu Community Health Service Center
Beijing
Hongyun Chi
- Not yet recruiting
Qingdao Municipal Hospital
Qingdao
Yibing Shao
- Not yet recruiting
Shanghai East Hospital
Shanghai
Ying Li
- Not yet recruiting
Wuhan Asia Heart Hospital
Wuhan
Yin Li
About this study
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.
- Being tested
- High-intensity interval training
- Keywords
- HFpEF, CPET, HIIT, Peak VO2, Exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-intensity interval trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| HIIT intervention group | Experimental | 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) Receives: Behavioral: High-intensity interval training |
| Standard care control group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak VO2
Peak VO2 (mL/kg/min) will be measured using symptom-limited incremental cardiopulmonary exercise testing performed on an electronically braked cycle ergometer
Measured: Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
Secondary outcomes (39)
Blood specimen
Lab tests include cytokines
Measured: Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
Blood specimen
Lab tests include high-sensitivity C-reactive protein (hs-CRP)
Measured: Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
Blood specimen
Lab tests include adipokines
Measured: Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
Blood specimen
Lab tests include N-terminal pro-B-type natriuretic peptide (NT-proBNP)
Measured: Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
Blood specimen
Lab tests include cardiac troponin
Measured: Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
Kansas City Cardiomyopathy Questionnaire (KCCQ)
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.
Measured: Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
The New York Heart Association (NYHA) Functional Classification
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).
Measured: Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
Montreal Cognitive Assessment (MoCA)
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.
Measured: Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
Hospital Anxiety and Depression Scale (HADS)
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).
Measured: Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
Pittsburgh Sleep Quality Index (PSQI)
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.
Measured: Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
International Physical Activity Questionnaire (IPAQ)
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)
Measured: Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
Peak O₂ pulse
Peak O₂ pulse will be assessed by cardiopulmonary exercise testing (CPET) .
Measured: Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
Anaerobic Threshold (AT)
Anaerobic Threshold (AT) will be assessed by cardiopulmonary exercise testing (CPET) .
Measured: Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
VE/VCO₂ slope
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).
Measured: Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
left atrial volume index (LAVI) assessed by echocardiography
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.
Measured: Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
left atrial volume index (LAVI) assessed by cardiac magnetic resonance(CMR)
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.
Measured: Baseline（week 0），End of study（week 24 ）
Left ventricular mass index (LVMI) assessed by echocardiography
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.
Measured: Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
Left ventricular mass index (LVMI) assessed by cardiac magnetic resonance(CMR)
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.
Measured: Baseline（week 0），End of study（week 24）
left atrial volume (LAV)
Left atrial volume (LAV) will be assessed using echocardiography , and will be reported in mL.
Measured: Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
left atrial area (LAA)
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.
Measured: Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
left atrial diameter (LAD)
Left atrial diameter (LAD) will be measured by echocardiography and reported in mm.
Measured: Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
Diastolic function index (E/e' ratio)
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.
Measured: Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
Global longitudinal strain (GLS)
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.
Measured: Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
Left ventricular myocardial work (MW)
Left ventricular myocardial work (MW) will be assessed by echocardiography and reported in mmHg%.
Measured: Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
Left atrial strain (LAS)
Left atrial strain (LAS) will be measured by echocardiography and reported in %.
Measured: Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
Epicardial adipose tissue volume (EATV)
Epicardial adipose tissue volume (EATV) will be quantified using cardiac magnetic resonance (CMR) and reported in mL.
Measured: Baseline（week 0），End of study（week 24 ）
Pericardial adipose tissue volume
Pericardial adipose tissue volume will be quantified using cardiac magnetic resonance (CMR) and reported in mL
Measured: Baseline（week 0），End of study（week 24 ）
Liver fat content (LFC)
Liver fat content (LFC) will be quantified using magnetic resonance imaging-derived proton density fat fraction (MRI-PDFF) and expressed as a percentage (%)
Measured: Baseline（week 0），End of study（week 24 ）
Liver Stiffness Measurement（LSM）assessed by magnetic resonance elastography (MRE)
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
Measured: Baseline（week 0），End of study（week 24 ）
Liver Stiffness Measurement（LSM）assessed by FibroTouch transient elastography
Liver stiffness measurement (LSM) will be assessed using the FibroTouch transient elastography system and reported in kilopascals (kPa).
Measured: Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
Visceral adipose tissue area (VATA)
Visceral adipose tissue area (VATA) will be measured using non-contrast chest CT and reported in cm²
Measured: Baseline（week 0），End of study（week 24 ）
BMI
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
Measured: Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
Waist-to-height ratio (WHtR)
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.
Measured: Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
Waist-to-hip ratio (WHR)
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.
Measured: Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
All-Cause Death
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.
Measured: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Heart failure rehospitalization
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.
Measured: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Exercise intervention-related adverse events
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.
Measured: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Clinical deterioration
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.
Measured: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Fecal specimens
Fecal specimens will be collected at baseline and Week 24 for gut microbiome profiling.
Measured: Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study start10 Aug 2026
- Primary completionJul 2027 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HFpEF - Heart Failure With Preserved Ejection FractionStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 192 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Municipal Health Commission, National Health Commission of the People's Republic of China
- Responsible party
- Principal investigator, Tang Yida, Peking University Third Hospital
- Investigators
- Yida Tang, MD,PhD, Study chair, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07693049
- Sponsor's protocol ID
- CPHIT-2
- Other IDs
- BRWEP2024W014090204, 2025ZD0546100, TY2025008
- Acronym
- CPHIT-HFpEF
- Status last verified
- Oct 2026
- First submitted
- 21 Jun 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiopulmonary Exercise Testing-based High-intensity Interval Training For Improving Heart Failure With Preserved Ejection Fraction
- ClinicalTrials.gov ID
- NCT07693049
- Acronym / sponsor ID
- CPHIT-HFpEF / CPHIT-2
- Keywords
- HFpEF, CPET, HIIT, Peak VO2, Exercise
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Collaborators
- Beijing Municipal Health Commission, National Health Commission of the People's Republic of China
- Study start
- 10 Aug 2026 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 9 Jul 2026 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIIT intervention group | Experimental | Behavioral: High-intensity interval trainingSubjects 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) |
| Standard care control group | No intervention | –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. |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men and women aged 35-70 years;
- 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);
- 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);
- Willingness to improve health status through appropriate exercise.
Key exclusion criteria (7 listed)
- Presence of contraindications to cardiopulmonary exercise testing (CPET);
- Positive findings on the exercise electrocardiogram (ECG) during CPET;
- Diagnosis of psychiatric disorders;
- Presence of movement disorders or lower extremity exercise-related injuries within the past 6 months;
- Women who are pregnant, breastfeeding, or planning to become pregnant in the near future;
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 |
|---|---|---|
| High-intensity interval trainingSubjects 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. | Behavioural | HIIT intervention group |
Primary outcome
Peak VO2
Time frame: Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
Peak VO2 (mL/kg/min) will be measured using symptom-limited incremental cardiopulmonary exercise testing performed on an electronically braked cycle ergometer
39 secondary outcomes
Blood specimen
Time frame: Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
Blood specimen
Time frame: Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
Blood specimen
Time frame: Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
Blood specimen
Time frame: Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
Blood specimen
Time frame: Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time frame: Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
The New York Heart Association (NYHA) Functional Classification
Time frame: Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
Montreal Cognitive Assessment (MoCA)
Time frame: Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
Hospital Anxiety and Depression Scale (HADS)
Time frame: Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
International Physical Activity Questionnaire (IPAQ)
Time frame: Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
Peak O₂ pulse
Time frame: Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
Anaerobic Threshold (AT)
Time frame: Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
VE/VCO₂ slope
Time frame: Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
left atrial volume index (LAVI) assessed by echocardiography
Time frame: Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
left atrial volume index (LAVI) assessed by cardiac magnetic resonance(CMR)
Time frame: Baseline（week 0），End of study（week 24 ）
Left ventricular mass index (LVMI) assessed by echocardiography
Time frame: Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
Left ventricular mass index (LVMI) assessed by cardiac magnetic resonance(CMR)
Time frame: Baseline（week 0），End of study（week 24）
left atrial volume (LAV)
Time frame: Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
left atrial area (LAA)
Time frame: Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
left atrial diameter (LAD)
Time frame: Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
Diastolic function index (E/e' ratio)
Time frame: Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
Global longitudinal strain (GLS)
Time frame: Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
Left ventricular myocardial work (MW)
Time frame: Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
Left atrial strain (LAS)
Time frame: Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
Epicardial adipose tissue volume (EATV)
Time frame: Baseline（week 0），End of study（week 24 ）
Pericardial adipose tissue volume
Time frame: Baseline（week 0），End of study（week 24 ）
Liver fat content (LFC)
Time frame: Baseline（week 0），End of study（week 24 ）
Liver Stiffness Measurement（LSM）assessed by magnetic resonance elastography (MRE)
Time frame: Baseline（week 0），End of study（week 24 ）
Liver Stiffness Measurement（LSM）assessed by FibroTouch transient elastography
Time frame: Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
Visceral adipose tissue area (VATA)
Time frame: Baseline（week 0），End of study（week 24 ）
BMI
Time frame: Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
Waist-to-height ratio (WHtR)
Time frame: Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
Waist-to-hip ratio (WHR)
Time frame: Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
All-Cause Death
Time frame: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Heart failure rehospitalization
Time frame: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Exercise intervention-related adverse events
Time frame: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Clinical deterioration
Time frame: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Fecal specimens
Time frame: Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Yida Tang, MD,PhD study chair
Peking University Third Hospital
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-intensity interval training in people with HFpEF - Heart Failure With Preserved Ejection Fraction, run by Peking University Third Hospital at 13 sites 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 5 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yida Tang, MD,PhD (010-82265996, tangyida@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak VO2 (time frame: Baseline（week 0），Mid-term（week 12），End of study（week 24 ）). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Oct 2026.