NCT06161987 EACH-ADHF: Early Comprehensive Rehabilitation in Patients With ADHF
| NCT ID | NCT06161987 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Guangdong Provincial People's Hospital |
| Condition | Acute Decompensated Heart Failure |
| Study Type | INTERVENTIONAL |
| Enrollment | 140 participants |
| Start Date | 2023-12-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 140 participants in total. It began in 2023-12-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
EACH-ADHF: Early Comprehensive Rehabilitation in patients with ADHF study is a multi-center, parallel-group, randomized controlled trial designed to evaluate the effects of the early comprehensive rehabilitation including exercise and inspiratory muscle training, over a period of 6 weeks, on the quality of life of patients with ADHF.
Eligibility Criteria
Inclusion Criteria: 1. Age between 18-80 2. At least one symptom of heart failure upon admission: Dyspnea at rest or with exertion, orthopnea, paroxysmal nocturnal dyspnea or exertional fatigue. 3. At least two of the signs of heart failure (HF): Distended jugular veins, enlarged cardiac silhouette, apex beat displacement, third heart sound, or increased jugular venous pressure/central venous pressure/pulmonary capillary wedge pressure. Pulmonary edema or pulmonary congestion (rales or chest X-ray/CT evidence of pulmonary congestion). Peripheral edema. Elevated B-type natriuretic peptide (\>100 pg/ml) or elevated NT-proBNP (\>300 pg/ml). 4. Able to independently perform basic activities of daily living before admission. 5. Able to complete the baseline assessment and initiate the specified treatment. 6. Able to walk 4 meters at the time of enrollment (assistive devices may be used). 7. Agree to participate in this study, sign a written informed consent form, and is willing to cooperate with follow-up. Exclusion Criteria: 1. Acute heart failure caused by acute myocardial infarction. 2. Severe aortic valve stenosis. 3. Hemodynamic instability caused by poorly controlled arrhythmias. 4. Severe heart failure and high-degree atrioventricular block, and inadequate heart rate response to pacing during exercise. 5. Isolated pulmonary hypertension. 6. Poorly controlled symptomatic orthostatic hypotension. 7. Hypertrophic obstructive cardiomyopathy. 8. Stage 5 chronic kidney failure, defined as glomerular filtration rate \<15 ml/(min·1.73m²) or requiring dialysis. 9. Undergoing screening tests with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels greater than or equal to 5 times the upper limit of the normal range defined by the center. 10. Awaiting a heart transplant or ventricular assist device implantation within six months, or having received a heart transplant. 11. A history of chronic lung disease except for COPD, previous lung surgery, or diseases affecting lung function, such as scoliosis. 12. Late-stage diseases other than heart failure. 13. Any medical history that could potentially affect protocol compliance, such as severe mental disorders, severe cognitive impairment, substance abuse, or addiction. 14. Severe language, psychological, or physical disabilities that prevent their participation in the program. 15. Pregnant or lactating women, or those of childbearing potential who are unwilling or unable to use effective contraceptive measures. 16. Involved in other interventional clinical trials. 17. Patients deemed unfit for participation in this study by the researchers.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06161987 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Acute Decompensated Heart Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06161987 currently recruiting?
Yes, NCT06161987 is actively recruiting participants. Contact the research team at mahuandoctor@163.com for enrollment information.
Where is the NCT06161987 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT06161987 clinical trial?
NCT06161987 is sponsored by Guangdong Provincial People's Hospital. The trial plans to enroll 140 participants.
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