Acute Decompensated Heart Failure (ADHF)NCT06795737
ExCR's Effects and Safety in Vulnerable ADHF Patients
A study testing Exercise rehabilitation and Conventional rehabilitation in people with Acute Decompensated Heart Failure (ADHF), run by YE Jing at 1 site in China.
Trial summary
Exercise-based cardiac rehabilitation has become a key component of the comprehensive care system for patients with stable heart failure (HF). However, due to hemodynamic instability and functional decline in early ADHF, most HF rehab studies exclude current/recent ADHF exacerbations. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Decompensated Heart Failure (ADHF)
- What is being tested?
- Exercise rehabilitation and Conventional rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteChina
- Study dates
- 17 Feb 2025to 30 Jun 2026
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hospitalized for ADHF for over 24 hours.
- Age 18-80 years.
- At least one acute heart failure symptom: dyspnea at rest or exertion, fatigue, orthopnea, or paroxysmal nocturnal dyspnea.
- At least two heart failure signs: confirmed pulmonary congestion or edema on exam or chest X-ray, jugular venous distension, peripheral edema, rapid weight gain (>2 kg in 3 days), or elevated BNP (≥100 ng/L) and NT-proBNP (≥300 ng/L).
- Change in heart failure treatment plan with initiation or increased dosage of: diuretics, vasodilators, positive inotropic agents (e.g., digoxin), or other neurohormonal modulators (ACEI/ARB/ARNI, β-blocker, MRA).
Who cannot join
- Indications for urgent cardiovascular surgery (e.g., heart transplantation, left ventricular assist device).
- Cardiogenic shock.
- Recent deep vein thrombosis.
- Severe cardiovascular diseases (e.g., severe aortic stenosis, mitral regurgitation).
- GFR <30 ml/min or need for dialysis during the study.
- Severe COPD (FEV1/FVC <0.7 post-bronchodilator, with severe defined as 30% ≤ FEV1 <50% predicted, and very severe as FEV1 <30% predicted).
- Severe frailty (Clinical Frailty Scale CFS ≥7).
- Mental, psychological, cognitive disorders, or substance dependence.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Peaking University First Hospital
Beijing, Beijing Municipality, 100032
Jing Ye, MSN., +86-13051163358, 1254139600@qq.com
Lihua Zhao, MSN., 18310775771, zhaolihua0601@163.com
About this study
Official title: Effectiveness and Safety of Exercise-based Cardiac Rehabilitation (ExCR) During the Vulnerable Period in Patients With Acute Decompensated Heart Failure (ADHF): A Randomized Controlled Trial
Exercise-based cardiac rehabilitation has become a key component of the comprehensive care system for patients with stable heart failure (HF). However, due to hemodynamic instability and functional decline in early ADHF, most HF rehab studies exclude current/recent ADHF exacerbations. Currently, ADHF management strategies lack robust evidence, and the timing, duration, and frequency of exercise interventions need further validation globally.
This study aims to address the following issues:
Read more
Develop an exercise management program for ADHF patients, verify its feasibility, and determine the safety and applicability of early exercise rehabilitation; Evaluate the improvement of participants in terms of physical function, cardiac function, and quality of life.
The research team will compare the formulated exercise rehabilitation program with conventional rehabilitation guidance to verify its feasibility and effectiveness.
Participants will:
Physicians and rehabilitation therapists will comprehensively assess the participants' conditions to determine the start time of rehabilitation training. Based on the patients' cardiac function, muscle strength, and heart failure-related clinical indicators, rehabilitation training is divided into two stages (the first stage is early in-hospital training, and the second stage is self-directed training after discharge). Exercise types mainly include respiratory training, bed activities, rehabilitation pedaling, and resistance training. Rehabilitation therapists and nurses will monitor participants' vital signs during the exercise process and choose the appropriate exercise intensity based on the participants' level of fatigue.
The exercise rehabilitation program will be evaluated and adjusted every two weeks for a total period of 12 weeks.
At the time of enrollment, discharge, two weeks after discharge, and four weeks after discharge, participants will need to complete questionnaires, including demographic and disease condition surveys, grip strength tests, Activities of Daily Living (ADL) scales, Short Physical Performance Battery (SPPB) scales, Minnesota Living with Heart Failure Questionnaire (MLHFQ) scales, and 6-minute walk tests, etc.
- Conditions
- Acute Decompensated Heart Failure (ADHF)
- Being tested
- Exercise rehabilitation, Conventional rehabilitation
- Keywords
- Acute Decompensated Heart Failure (ADHF)；Vulnerable Phase；Exercise Rehabilitation；RCT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise rehabilitationBehavioural
The experimental group's protocol consists of two stages: in-hospital Phase I and post-discharge self-training. For Phase I, cardiac and rehab specialists assess NYHA classification, muscle strength, and mobility to create an exercise plan, supervised by therapists and nurses. Phase II involves twice-weekly outpatient rehab for 24 sessions and weekly remote guidance with WeChat and wristbands to track vitals, totaling 12 remote sessions. Exercise prescriptions are customized based on 6MWTD outcomes, with ongoing support from rehab staff and nurses.
Conventional rehabilitationBehavioural
Health Education: Nurses provide manuals on heart failure causes, treatment, diet, exercise (detailing frequency, intensity, duration, types, and safety), and self-monitoring to control group patients.
Outpatient Follow-up: Post-discharge, heart failure patients have follow-ups at 2 weeks, 1 month, 2 months, and 3 months. A multidisciplinary team of doctors, pharmacists, and nurses handles these, with doctors for assessment, pharmacists for medication education, and nurses for self-care assessment and education.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Exercise rehabilitation Receives: Behavioral: Exercise rehabilitation |
| Control group | Sham comparator | Conventional rehabilitation Receives: Behavioral: Conventional rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the 6-minute walking test distance
Assess the changes in participants' 6MWT distance at baseline and 1, 2, and 3 months post-discharge.
Measured: From enrollment to the end of the 12-week exercise rehabilitation intervention.
Secondary outcomes (9)
Left Ventricular Ejection Fraction （LVEF%）
Assess the changes in participants' LVEF% at baseline and 1, 2, and 3 months post-discharge.
Measured: From enrollment to the end of the 12-week exercise rehabilitation intervention.
Brain Natriuretic Peptide（BNP）
Assess the changes in participants' BNP at baseline and 1, 2, and 3 months post-discharge.
Measured: From enrollment to the end of the 12-week exercise rehabilitation intervention.
NYHA class
Assess the changes in participants' NYHA class at baseline and 1, 2, and 3 months post-discharge.
Measured: From enrollment to the end of the 12-week exercise rehabilitation intervention.
Grip strength
Assess grip strength using a dynamometer（CAMRY brand electronic hand dynamometer）; participants squeeze twice with their dominant hand and record the average.
Measured: From enrollment to the end of the 12-week exercise rehabilitation intervention.
Length of hospitalization
Length of hospitalization will be compared between intervention and control groups at discharge.
Measured: From hospitalization to discharge, an average of 12 weeks.
Short Physical Performance Battery（SPPB）
SPPB : Assesses physical performance with three tests: balance, 4-meter gait speed, and repeated chair stands. Each test scores 0-4; total score 0-12. Scores: 0-6 (poor), 7-9 (moderate), 10-12 (good).The SPPB scale will assess participants' physical performance at enrollment and 1, 2, and 3 months post-discharge.
Measured: From enrollment to the end of the 12-week exercise rehabilitation intervention.
Activities of Daily Living（ADL）
Barthel Index: 10 items (feeding, bathing, grooming, dressing, bowel control, bladder control, toilet use, transfers, walking, stairs). Each item scored 0, 5, 10, 15; total 0-100. ≤40: severe dependence; 41-60: moderate; 61-99: mild; 100: independent. Higher scores indicate greater self-care ability.The Barthel Index will be used to assess ADL changes in participants at baseline and 1, 2, and 3 months post-discharge.
Measured: From enrollment to the end of the 12-week exercise rehabilitation intervention.
Quality of life using MLHFQ scale
MLHFQ scale: 21-item questionnaire assessing heart failure's impact on quality of life over the past month. Three domains: physical (8 items), emotional (5 items), and other (8 items). Each item scored 0-5 (0=none, 1=rarely, 2=occasionally, 3=sometimes, 4=often, 5=always). Total score: 0-105. Higher scores indicate worse quality of life; lower scores indicate better quality of life.The Minnesota Living with Heart Failure Questionnaire will be used to assess QoL changes in participants at baseline and 1, 2, and 3 months post-discharge.
Measured: From enrollment to the end of the 12-week exercise rehabilitation intervention.
Degree of frailty.
Clinical Frailty Scale: 1-9 scale (very fit, well, managing well, vulnerable, mildly frail, moderately frail, severely frail, very severely frail, terminally ill). Score ≥5 indicates frailty.The Clinical Frailty Scale will be used to assess frailty changes in participants at baseline and at 1, 2, and 3 months post-discharge.
Measured: From enrollment to the end of the 12-week exercise rehabilitation intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2025
- Study start17 Feb 2025 (estimated)
- Primary completion17 Feb 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Acute Decompensated Heart Failure (ADHF)Studies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- YE Jing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, YE Jing, Peking University First Hospital
- Investigators
- Jing Ye, MSN., Study chair, Peaking University First HospitalYimeng Jiang, Ph.D., Study director, Peaking University First HospitalLihua Zhao, MSN., Principal investigator, Peaking University First HospitalWenhui Ding, Prof., Principal investigator, Peaking University First HospitalXiaoning Han, Ph.D., Principal investigator, Peaking University First HospitalLei Yang, Principal investigator, Peaking University First HospitalYuling Wang, Principal investigator, Peaking University First HospitalBaiyu Zhang, Principal investigator, Peaking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06795737
- Sponsor's protocol ID
- Peaking UFH
- Status last verified
- Dec 2024
- First submitted
- 19 Dec 2024
- Last updated
- 28 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Chioncel O, Mebazaa A, Maggioni AP, Harjola VP, Rosano G, Laroche C, Piepoli MF, Crespo-Leiro MG, Lainscak M, Ponikowski P, Filippatos G, Ruschitzka F, Seferovic P, Coats AJS, Lund LH; ESC-EORP-HFA Heart Failure Long-Term Registry Investigators. Acute heart failure congestion and perfusion status - impact of the clinical classification on in-hospital and long-term outcomes; insights from the ESC-EORP-HFA Heart Failure Long-Term Registry. Eur J Heart Fail. 2019 Nov;21(11):1338-1352. doi: 10.1002/ejhf.1492. Epub 2019 May 24.
PubMed 31127678Pack QR, Priya A, Lagu T, Pekow PS, Berry R, Atreya AR, Ades PA, Lindenauer PK. Cardiac Rehabilitation Utilization During an Acute Cardiac Hospitalization: A NATIONAL SAMPLE. J Cardiopulm Rehabil Prev. 2019 Jan;39(1):19-26. doi: 10.1097/HCR.0000000000000374.
PubMed 30586111Patti A, Merlo L, Ambrosetti M, Sarto P. Exercise-Based Cardiac Rehabilitation Programs in Heart Failure Patients. Heart Fail Clin. 2021 Apr;17(2):263-271. doi: 10.1016/j.hfc.2021.01.007. Epub 2021 Feb 12.
PubMed 33673950Lesyuk W, Kriza C, Kolominsky-Rabas P. Cost-of-illness studies in heart failure: a systematic review 2004-2016. BMC Cardiovasc Disord. 2018 May 2;18(1):74. doi: 10.1186/s12872-018-0815-3.
PubMed 29716540Taylor RS, Walker S, Smart NA, Piepoli MF, Warren FC, Ciani O, Whellan D, O'Connor C, Keteyian SJ, Coats A, Davos CH, Dalal HM, Dracup K, Evangelista LS, Jolly K, Myers J, Nilsson BB, Passino C, Witham MD, Yeh GY; ExTraMATCH II Collaboration. Impact of Exercise Rehabilitation on Exercise Capacity and Quality-of-Life in Heart Failure: Individual Participant Meta-Analysis. J Am Coll Cardiol. 2019 Apr 2;73(12):1430-1443. doi: 10.1016/j.jacc.2018.12.072.
PubMed 30922474Maddocks S, Cobbing S. Patients' Experiences of and Perspectives on Phase 1 Cardiac Rehabilitation after Coronary Artery Bypass Graft Surgery. Physiother Can. 2017;69(4):333-340. doi: 10.3138/ptc.2016-39GH.
PubMed 30369701Authors/Task Force Members:; McDonagh TA, Metra M, Adamo M, Gardner RS, Baumbach A, Bohm M, Burri H, Butler J, Celutkiene J, Chioncel O, Cleland JGF, Coats AJS, Crespo-Leiro MG, Farmakis D, Gilard M, Heymans S, Hoes AW, Jaarsma T, Jankowska EA, Lainscak M, Lam CSP, Lyon AR, McMurray JJV, Mebazaa A, Mindham R, Muneretto C, Francesco Piepoli M, Price S, Rosano GMC, Ruschitzka F, Kathrine Skibelund A; ESC Scientific Document Group. 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: Developed by the Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC). With the special contribution of the Heart Failure Association (HFA) of the ESC. Eur J Heart Fail. 2022 Jan;24(1):4-131. doi: 10.1002/ejhf.2333.
PubMed 35083827Zou CH, Zhang J. [Interpretation of 2023 ESC focused update of the 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure]. Zhonghua Xin Xue Guan Bing Za Zhi. 2023 Dec 24;51(12):1268-1272. doi: 10.3760/cma.j.cn112148-20230908-00143. Chinese.
PubMed 38123211Ye J, Zhao L, Jiang Y, Hu L, Yang L, Wang Y, Ding W, Zheng Y. Effectiveness and safety of exercise-based cardiac rehabilitation (ExCR) during the vulnerable period in patients with acute decompensated heart failure (ADHF): a randomised controlled trial protocol. BMJ Open. 2025 Sep 21;15(9):e102812. doi: 10.1136/bmjopen-2025-102812.
PubMed 40976670
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of Exercise-based Cardiac Rehabilitation (ExCR) During the Vulnerable Period in Patients With Acute Decompensated Heart Failure (ADHF): A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06795737
- Acronym / sponsor ID
- Peaking UFH
- Conditions
- Acute Decompensated Heart Failure (ADHF)
- Keywords
- Acute Decompensated Heart Failure (ADHF)；Vulnerable Phase；Exercise Rehabilitation；RCT
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- YE JingUniversity, hospital or other
- Study start
- 17 Feb 2025 (estimated)
- Primary completion
- 17 Feb 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 28 Jan 2025 (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.
Exercise-based cardiac rehabilitation has become a key component of the comprehensive care system for patients with stable heart failure (HF). However, due to hemodynamic instability and functional decline in early ADHF, most HF rehab studies exclude current/recent ADHF exacerbations. Currently, ADHF management strategies lack robust evidence, and the timing, duration, and frequency of exercise interventions need further validation globally.
This study aims to address the following issues:
Develop an exercise management program for ADHF patients, verify its feasibility, and determine the safety and applicability of early exercise rehabilitation; Evaluate the improvement of participants in terms of physical function, cardiac function, and quality of life.
The research team will compare the formulated exercise rehabilitation program with conventional rehabilitation guidance to verify its feasibility and effectiveness.
Participants will:
Physicians and rehabilitation therapists will comprehensively assess the participants' conditions to determine the start time of rehabilitation training. Based on the patients' cardiac function, muscle strength, and heart failure-related clinical indicators, rehabilitation training is divided into two stages (the first stage is early in-hospital training, and the second stage is self-directed training after discharge). Exercise types mainly include respiratory training, bed activities, rehabilitation pedaling, and resistance training. Rehabilitation therapists and nurses will monitor participants' vital signs during the exercise process and choose the appropriate exercise intensity based on the participants' level of fatigue.
The exercise rehabilitation program will be evaluated and adjusted every two weeks for a total period of 12 weeks.
At the time of enrollment, discharge, two weeks after discharge, and four weeks after discharge, participants will need to complete questionnaires, including demographic and disease condition surveys, grip strength tests, Activities of Daily Living (ADL) scales, Short Physical Performance Battery (SPPB) scales, Minnesota Living with Heart Failure Questionnaire (MLHFQ) scales, and 6-minute walk tests, etc.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: Exercise rehabilitationExercise rehabilitation |
| Control group | Sham comparator | Behavioral: Conventional rehabilitationConventional rehabilitation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Hospitalized for ADHF for over 24 hours.
- Age 18-80 years.
- At least one acute heart failure symptom: dyspnea at rest or exertion, fatigue, orthopnea, or paroxysmal nocturnal dyspnea.
- At least two heart failure signs: confirmed pulmonary congestion or edema on exam or chest X-ray, jugular venous distension, peripheral edema, rapid weight gain (>2 kg in 3 days), or elevated BNP (≥100 ng/L) and NT-proBNP (≥300 ng/L).
- Change in heart failure treatment plan with initiation or increased dosage of: diuretics, vasodilators, positive inotropic agents (e.g., digoxin), or other neurohormonal modulators (ACEI/ARB/ARNI, β-blocker, MRA).
Key exclusion criteria (8 listed)
- Indications for urgent cardiovascular surgery (e.g., heart transplantation, left ventricular assist device).
- Cardiogenic shock.
- Recent deep vein thrombosis.
- Severe cardiovascular diseases (e.g., severe aortic stenosis, mitral regurgitation).
- GFR <30 ml/min or need for dialysis during the study.
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 |
|---|---|---|
| Exercise rehabilitationThe experimental group's protocol consists of two stages: in-hospital Phase I and post-discharge self-training. For Phase I, cardiac and rehab specialists assess NYHA classification, muscle strength, and mobility to create an exercise plan, supervised by therapists and nurses. Phase II involves twice-weekly outpatient rehab for 24 sessions and weekly remote guidance with WeChat and wristbands to track vitals, totaling 12 remote sessions. Exercise prescriptions are customized based on 6MWTD outcomes, with ongoing support from rehab staff and nurses. | Behavioural | Experimental group |
| Conventional rehabilitationHealth Education: Nurses provide manuals on heart failure causes, treatment, diet, exercise (detailing frequency, intensity, duration, types, and safety), and self-monitoring to control group patients. Outpatient Follow-up: Post-discharge, heart failure patients have follow-ups at 2 weeks, 1 month, 2 months, and 3 months. A multidisciplinary team of doctors, pharmacists, and nurses handles these, with doctors for assessment, pharmacists for medication education, and nurses for self-care assessment and education. | Behavioural | Control group |
Primary outcome
Change in the 6-minute walking test distance
Time frame: From enrollment to the end of the 12-week exercise rehabilitation intervention.
Assess the changes in participants' 6MWT distance at baseline and 1, 2, and 3 months post-discharge.
9 secondary outcomes
Left Ventricular Ejection Fraction （LVEF%）
Time frame: From enrollment to the end of the 12-week exercise rehabilitation intervention.
Brain Natriuretic Peptide（BNP）
Time frame: From enrollment to the end of the 12-week exercise rehabilitation intervention.
NYHA class
Time frame: From enrollment to the end of the 12-week exercise rehabilitation intervention.
Grip strength
Time frame: From enrollment to the end of the 12-week exercise rehabilitation intervention.
Length of hospitalization
Time frame: From hospitalization to discharge, an average of 12 weeks.
Short Physical Performance Battery（SPPB）
Time frame: From enrollment to the end of the 12-week exercise rehabilitation intervention.
Activities of Daily Living（ADL）
Time frame: From enrollment to the end of the 12-week exercise rehabilitation intervention.
Quality of life using MLHFQ scale
Time frame: From enrollment to the end of the 12-week exercise rehabilitation intervention.
Degree of frailty.
Time frame: From enrollment to the end of the 12-week exercise rehabilitation intervention.
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 28 Jan 2025.
- Background: PubMed 31127678Chioncel O, Mebazaa A, Maggioni AP, Harjola VP, Rosano G, Laroche C, Piepoli MF, Crespo-Leiro MG, Lainscak M, Ponikowski P, Filippatos G, Ruschitzka F, Seferovic P, Coats AJS, Lund LH; ESC-EORP-HFA Heart Failure Long-Term Registry Investigators. Acute heart failure congestion and perfusion status - impact of the clinical classification on in-hospital and long-term outcomes; insights from the ESC-EORP-HFA Heart Failure Long-Term Registry. Eur J Heart Fail. 2019 Nov;21(11):1338-1352. doi: 10.1002/ejhf.1492. Epub 2019 May 24.
- Background: PubMed 30586111Pack QR, Priya A, Lagu T, Pekow PS, Berry R, Atreya AR, Ades PA, Lindenauer PK. Cardiac Rehabilitation Utilization During an Acute Cardiac Hospitalization: A NATIONAL SAMPLE. J Cardiopulm Rehabil Prev. 2019 Jan;39(1):19-26. doi: 10.1097/HCR.0000000000000374.
- Background: PubMed 33673950Patti A, Merlo L, Ambrosetti M, Sarto P. Exercise-Based Cardiac Rehabilitation Programs in Heart Failure Patients. Heart Fail Clin. 2021 Apr;17(2):263-271. doi: 10.1016/j.hfc.2021.01.007. Epub 2021 Feb 12.
- Background: PubMed 29716540Lesyuk W, Kriza C, Kolominsky-Rabas P. Cost-of-illness studies in heart failure: a systematic review 2004-2016. BMC Cardiovasc Disord. 2018 May 2;18(1):74. doi: 10.1186/s12872-018-0815-3.
- Background: PubMed 30922474Taylor RS, Walker S, Smart NA, Piepoli MF, Warren FC, Ciani O, Whellan D, O'Connor C, Keteyian SJ, Coats A, Davos CH, Dalal HM, Dracup K, Evangelista LS, Jolly K, Myers J, Nilsson BB, Passino C, Witham MD, Yeh GY; ExTraMATCH II Collaboration. Impact of Exercise Rehabilitation on Exercise Capacity and Quality-of-Life in Heart Failure: Individual Participant Meta-Analysis. J Am Coll Cardiol. 2019 Apr 2;73(12):1430-1443. doi: 10.1016/j.jacc.2018.12.072.
- Background: PubMed 30369701Maddocks S, Cobbing S. Patients' Experiences of and Perspectives on Phase 1 Cardiac Rehabilitation after Coronary Artery Bypass Graft Surgery. Physiother Can. 2017;69(4):333-340. doi: 10.3138/ptc.2016-39GH.
- Background: PubMed 35083827Authors/Task Force Members:; McDonagh TA, Metra M, Adamo M, Gardner RS, Baumbach A, Bohm M, Burri H, Butler J, Celutkiene J, Chioncel O, Cleland JGF, Coats AJS, Crespo-Leiro MG, Farmakis D, Gilard M, Heymans S, Hoes AW, Jaarsma T, Jankowska EA, Lainscak M, Lam CSP, Lyon AR, McMurray JJV, Mebazaa A, Mindham R, Muneretto C, Francesco Piepoli M, Price S, Rosano GMC, Ruschitzka F, Kathrine Skibelund A; ESC Scientific Document Group. 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: Developed by the Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC). With the special contribution of the Heart Failure Association (HFA) of the ESC. Eur J Heart Fail. 2022 Jan;24(1):4-131. doi: 10.1002/ejhf.2333.
- Background: PubMed 38123211Zou CH, Zhang J. [Interpretation of 2023 ESC focused update of the 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure]. Zhonghua Xin Xue Guan Bing Za Zhi. 2023 Dec 24;51(12):1268-1272. doi: 10.3760/cma.j.cn112148-20230908-00143. Chinese.
- Derived from this study: PubMed 40976670Ye J, Zhao L, Jiang Y, Hu L, Yang L, Wang Y, Ding W, Zheng Y. Effectiveness and safety of exercise-based cardiac rehabilitation (ExCR) during the vulnerable period in patients with acute decompensated heart failure (ADHF): a randomised controlled trial protocol. BMJ Open. 2025 Sep 21;15(9):e102812. doi: 10.1136/bmjopen-2025-102812.
- Individual participant dataSharing planned: Yes
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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.
Jing Ye, MSN. study chair
Peaking University First Hospital
Yimeng Jiang, Ph.D. study director
Peaking University First Hospital
Lihua Zhao, MSN. principal investigator
Peaking University First Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise rehabilitation and Conventional rehabilitation in people with Acute Decompensated Heart Failure (ADHF), run by YE Jing 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 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Jan 2025. 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. Some participants in this study may receive a placebo. 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 Jing Ye, MSN. (+86-13051163358, 274601918@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the 6-minute walking test distance (time frame: From enrollment to the end of the 12-week exercise rehabilitation intervention.). 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 NCT06795737, which also lists 9 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 28 Jan 2025.