About this trial
This study aims to investigate the efficacy and safety of exercise rehabilitation in patients with cardiorenal syndrome (CRS).
Building on previous research demonstrating that exercise rehabilitation can effectively improve cardiac function and cardiopulmonary endurance in patients with chronic heart failure, this study will further explore its role in the context of CRS, a condition where such effects remain understudied. CRS patients typically exhibit reduced cardiopulmonary endurance, with significantly lower peak oxygen uptake (VO₂ peak) and 6-minute walk test (6MWT) distance compared to non-CRS patients.
Adults aged 18-75 with chronic heart failure with reduced ejection fraction (HFrEF) complicated by chronic renal insufficiency will be enrolled and randomly assigned to two groups: 1. Basic treatment group: 30 patients receive only basic drug treatment for 6 months. 2. Exercise rehabilitation group: 30 patients receive basic drug treatment combined with home-based exercise rehabilitation for 6 months (with personalized exercise prescriptions formulated based on cardiopulmonary exercise test results or 6MWT for those unable to complete the former). The study will explore the efficacy and safety of exercise rehabilitation in the prevention and management of CRS by comparing changes in target biomarkers, renal function indicators, cardiac function indicators, cardiopulmonary exercise test results, Minnesota Living with Heart Failure Questionnaire scores, and the incidence of adverse events before and after treatment between the two groups.
The participants will:
Complete cardiopulmonary exercise tests or 6MWT before treatment initiation. Receive basic drug treatment; those in the exercise rehabilitation group will additionally perform home-based exercise rehabilitation according to the exercise prescription.
Attend regular follow-up visits within 6 months. Undergo assessments of related indicators (biomarkers, renal function, cardiac function, etc.) before and after treatment.
Eligibility criteria
Qualifiers
Patients with chronically stable HFrEF complicated by kidney dysfunction (eGFR < 90 mL/min/1.73m²)
NYHA class II-III
Low risk in exercise risk assessment
Aged 18-75 years
Disqualifiers
Uncontrolled hypertension
Severe arrhythmias (including frequent ventricular premature contractions, ventricular tachycardia, rapid atrial fibrillation, sick sinus syndrome, and second-degree or higher atrioventricular block)
Obstructive hypertrophic cardiomyopathy
Moderate to severe stenotic valvular heart disease
Trial design
Treatments tested in this trial
- Standardized Basic Drug Therapy for HFrEF with Chronic Kidney Dysfunction
- Home-based Personalized Exercise Rehabilitation
Treatment groups
Sponsors and collaborators
Haiyan Pan
Lead sponsor
Affiliated Hospital of Nantong University
Sponsor institution