EACH-ADHF: Early Comprehensive Rehabilitation in Patients With ADHF

Recruiting now · Not applicable

Conditions studied: Acute Decompensated Heart Failure

In brief

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.

Key facts

Study ID

NCT06161987

Run by

Guangdong Provincial People's Hospital

People needed

140

Starts

2023-12-01

Expected to finish

2027-06-30

Last updated by the study team

2025-08-17

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Guangdong Provincial People's Hospital — Guangzhou, Guangdong, China (enrolling)

Full record on ClinicalTrials.gov

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