Early comprehensive rehabilitation for patients with acute decompensated heart failure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Guangdong Provincial People's Hospital
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Huan Ma, PhD
• Email: mahuandoctor@163.com
• Phone: +86 15078755932

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.