EACH-ADHF: Early Comprehensive Rehabilitation in Patients With ADHF

Launched by GUANGDONG PROVINCIAL PEOPLE'S HOSPITAL · Nov 29, 2023

Keywords

ClinConnect Summary

The EACH-ADHF trial is a research study looking at how early rehabilitation can help patients who are experiencing acute decompensated heart failure, a condition where the heart cannot pump blood effectively, leading to symptoms like shortness of breath and fatigue. This study aims to see if a program that includes exercise and breathing exercises over six weeks can improve the quality of life for these patients.

To participate, individuals should be between 18 and 80 years old and show at least one symptom of heart failure when they are admitted to the hospital. They should also be able to do basic daily activities independently and walk a short distance (4 meters) with or without help. If you or a loved one is considering joining this trial, you'll need to agree to participate and sign a consent form. Participants can expect a supportive rehabilitation program tailored to help them recover and feel better. It's important to note that certain health conditions may disqualify someone from joining, so discussing eligibility with a healthcare provider is essential.

Gender

ALL

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.