NCT06161987Recruiting
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.
Source: ClinicalTrials.gov · Last updated 17 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 140 (estimated)
- First submitted
- 19 Jul 2023
- Start date
- 1 Dec 2023
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Guangdong Provincial People's Hospital
- Diseases
- Heart failure
- NCT number
- NCT06161987
What you commit to
- Study type: Interventional
- Planned participants: 140
- From 1 Dec 2023 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Acute heart failure caused by acute myocardial infarction.
- 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.
- Stage 5 chronic kidney failure, defined as glomerular filtration rate \<15 ml/(min·1.73m²) or requiring dialysis.
- 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.
Lab values
- 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.
Other
- Severe aortic valve stenosis.
- Poorly controlled symptomatic orthostatic hypotension.
- Hypertrophic obstructive cardiomyopathy.
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Guangdong Provincial People's Hospital Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.