Early comprehensive rehabilitation for patients with acute decompensated heart failure

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

This study is testing if a 6-week rehabilitation program that includes exercise can help improve the quality of life for people with acute heart failure compared to regular care.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 140 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Guangdong Provincial People's Hospital (Academic / other)
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT06161987 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effects of a 6-week early comprehensive rehabilitation program, which includes exercise and inspiratory muscle training, on the quality of life of patients with acute decompensated heart failure (ADHF). Conducted at Guangdong Provincial People's Hospital and 12 satellite centers, the study will randomly assign 140 consenting patients to either the rehabilitation program or a control group receiving usual care. The primary outcomes will focus on improvements in the Kansas City Cardiomyopathy Questionnaire (KCCQ) and inspiratory muscle strength, while secondary outcomes will assess physical function, cardiac function, psychological status, and rates of hospital readmission and mortality. Follow-up assessments will occur up to 6 months post-discharge.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-80 who exhibit symptoms and signs of heart failure upon admission and can perform basic daily activities independently.

Not a fit: Patients who are unable to walk 4 meters at the time of enrollment or have severe comorbidities that prevent participation in rehabilitation may not benefit from this study.

Why it matters

Potential benefit: If successful, this rehabilitation program could significantly improve the quality of life and functional outcomes for patients with acute decompensated heart failure.

How similar studies have performed: Other studies have shown promising results with similar rehabilitation approaches in heart failure patients, indicating potential for success in this trial.

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.

Where this trial is running

Guangzhou, Guangdong

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

Study contacts

• Study coordinator: Huan Ma, PhD

Conditions Acute Decompensated Heart Failure; Acute decompensated heart failure; Early comprehensive rehabilitation; Inspiratory muscle training; Exercise training; KCCQ