ExCR's Effects and Safety in Vulnerable ADHF Patients

Launched by YE JING · Jan 26, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the effects and safety of an exercise program for patients with Acute Decompensated Heart Failure (ADHF), which is a serious condition where the heart cannot pump blood effectively. The researchers want to see if an early exercise rehabilitation program can help improve patients' physical abilities, heart function, and overall quality of life. They will compare this new exercise program with the usual rehabilitation guidance to see which is more effective.

To participate in this study, individuals must be hospitalized for ADHF for more than 24 hours, be between 18 and 80 years old, and have specific symptoms and signs of heart failure. During the trial, participants will engage in a structured exercise plan that includes activities like breathing exercises, light movements, and strength training, with support from rehabilitation therapists and nurses. They will be monitored closely to ensure safety, and their progress will be checked regularly through various tests and questionnaires over a 12-week period. This research aims to provide better evidence for exercise interventions in managing ADHF, which is currently lacking in the medical field.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Hospitalized for ADHF for over 24 hours.
• • 2. Age 18-80 years.
• • 3. At least one acute heart failure symptom: dyspnea at rest or exertion, fatigue, orthopnea, or paroxysmal nocturnal dyspnea.
• • 4. At least two heart failure signs: confirmed pulmonary congestion or edema on exam or chest X-ray, jugular venous distension, peripheral edema, rapid weight gain (\>2 kg in 3 days), or elevated BNP (≥100 ng/L) and NT-proBNP (≥300 ng/L).
• • 5. Change in heart failure treatment plan with initiation or increased dosage of: diuretics, vasodilators, positive inotropic agents (e.g., digoxin), or other neurohormonal modulators (ACEI/ARB/ARNI, β-blocker, MRA).
• Exclusion Criteria:
• • 1. Indications for urgent cardiovascular surgery (e.g., heart transplantation, left ventricular assist device).
• • 2. Cardiogenic shock.
• • 3. Recent deep vein thrombosis.
• • 4. Severe cardiovascular diseases (e.g., severe aortic stenosis, mitral regurgitation).
• • 5. GFR \<30 ml/min or need for dialysis during the study.
• • 6. Severe COPD (FEV1/FVC \<0.7 post-bronchodilator, with severe defined as 30% ≤ FEV1 \<50% predicted, and very severe as FEV1 \<30% predicted).
• • 7. Severe frailty (Clinical Frailty Scale CFS ≥7).
• • 8. Mental, psychological, cognitive disorders, or substance dependence.