Status:
RECRUITING
EACH-ADHF: Early Comprehensive Rehabilitation in Patients With ADHF
Lead Sponsor:
Guangdong Provincial People's Hospital
Conditions:
Acute Decompensated Heart Failure
Eligibility:
All Genders
18-80 years
Phase:
NA
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 reh...
Detailed Description
Guangdong Provincial People's Hospital will be the lead center, with an additional 8 hospitals designated as satellite centers for the study. To sum up, these centers will recruit a total of 140 conse...
Eligibility Criteria
Inclusion
- Age between 18-80
- At least one symptom of heart failure upon admission:
- Dyspnea at rest or with exertion, orthopnea, paroxysmal nocturnal dyspnea or exertional fatigue.
- 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).
- Able to independently perform basic activities of daily living before admission.
- Able to complete the baseline assessment and initiate the specified treatment.
- Able to walk 4 meters at the time of enrollment (assistive devices may be used).
- Agree to participate in this study, sign a written informed consent form, and is willing to cooperate with follow-up.
Exclusion
- Acute heart failure caused by acute myocardial infarction.
- Severe aortic valve stenosis.
- Hemodynamic instability caused by poorly controlled arrhythmias.
- Severe heart failure and high-degree atrioventricular block, and inadequate heart rate response to pacing during exercise.
- Isolated pulmonary hypertension.
- Poorly controlled symptomatic orthostatic hypotension.
- Hypertrophic obstructive cardiomyopathy.
- Stage 5 chronic kidney failure, defined as glomerular filtration rate \<15 ml/(min·1.73m²) or requiring dialysis.
- 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.
- Awaiting a heart transplant or ventricular assist device implantation within six months, or having received a heart transplant.
- A history of chronic lung disease except for COPD, previous lung surgery, or diseases affecting lung function, such as scoliosis.
- Late-stage diseases other than heart failure.
- Any medical history that could potentially affect protocol compliance, such as severe mental disorders, severe cognitive impairment, substance abuse, or addiction.
- Severe language, psychological, or physical disabilities that prevent their participation in the program.
- Pregnant or lactating women, or those of childbearing potential who are unwilling or unable to use effective contraceptive measures.
- Involved in other interventional clinical trials.
- Patients deemed unfit for participation in this study by the researchers.
Key Trial Info
Start Date :
December 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2027
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT06161987
Start Date
December 1 2023
End Date
June 30 2027
Last Update
August 17 2025
Active Locations (1)
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1
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China, 510080