RecruitingNot ApplicableNCT06161987

EACH-ADHF: Early Comprehensive Rehabilitation in Patients With ADHF

Efficacy and Safety of Early Comprehensive Rehabilitation in Patients With ADHF, A Multicenter, Randomized, Controlled Trial.

Sponsor

Guangdong Provincial People's Hospital

Enrollment

140 participants

Start Date

Dec 1, 2023

Study Type

INTERVENTIONAL

Conditions

Acute Decompensated Heart Failure

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

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria11

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 Criteria17

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.

Interventions

BEHAVIORALEarly comprehensive rehabilitation

Patients randomized to the rehabilitation intervention group will be offered comprehensive rehabilitation plan containing 18 sessions of a structured outpatient-based exercise program over 6 weeks (3 times per week).