Cardiopulmonary Exercise Testing-based High-intensity Interval Training For Improving Heart Failure With Preserved Ejection Fraction
CPHIT-HFpEF
4 other identifiers
interventional
192
1 country
12
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2026
Typical duration for not_applicable
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 21, 2026
CompletedStudy Start
First participant enrolled
July 1, 2026
CompletedFirst Posted
Study publicly available on registry
July 9, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 30, 2028
July 14, 2026
July 1, 2026
1 year
June 21, 2026
July 12, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Peak VO2
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 ）
Secondary Outcomes (39)
Blood specimen
Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
Blood specimen
Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
Blood specimen
Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
Blood specimen
Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
Blood specimen
Baseline（week 0），Mid-term（week 12），End of study（week 24 ）
- +34 more secondary outcomes
Study Arms (2)
HIIT intervention group
EXPERIMENTALSubjects 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 INTERVENTIONControl 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Beijing Chao-Yang Hospital, Capital Medical University
Beijing, China
Beijing Hospital
Beijing, China
Beijing Xiaotangshan Hospital
Beijing, China
Beijing Zhongguancun Hospital
Beijing, China
Community Health Station of the Party School of the Central Committee of C.P.C
Beijing, China
Jimenli Community Health Service Center
Beijing, China
Peking University First Hospital
Beijing, China
Peking University People's Hospital
Beijing, China
Peking University Third Hospital
Beijing, China
Xueyuanlu Community Health Service Center
Beijing, China
Shanghai East Hospital
Shanghai, China
Wuhan Asia Heart Hospital
Wuhan, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Yida Tang, MD,PhD
Peking University Third Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Only blinding is maintained for data management personnel, laboratory testing personnel, and data analysts, while not applied to subjects and clinical investigators in the clinical trial.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Vice President of Peking University Third Hospital; Director of Institute of Vascular Medicine, Peking University Third Hospital; Deputy Director, State Key Laboratory of Vascular Homeostasis and Remodeling
Study Record Dates
First Submitted
June 21, 2026
First Posted
July 9, 2026
Study Start
July 1, 2026
Primary Completion (Estimated)
July 1, 2027
Study Completion (Estimated)
April 30, 2028
Last Updated
July 14, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will not share