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Efficacy and Safety of Home-Based Exercise Rehabilitation in Patients With Cardiorenal Syndrome Complicated by Chronic Heart Failure With Reduced Ejection Fraction (HFrEF): A Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Drug, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
The Affiliated Hospital of Nantong University
RECRUITING
Nantong
Time Frame
Start Date: 2025-09-15
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 60
Treatments
Active_comparator: Basic Treatment Group
Patients with HFrEF and chronic kidney dysfunction receive 6 months of basic drug treatment, with regular follow-up during the period.
Experimental: Exercise Rehabilitation Group
Patients with HFrEF and chronic kidney dysfunction receive 6 months of basic drug treatment combined with home-based exercise rehabilitation. Exercise prescriptions are formulated based on cardiopulmonary exercise test results (using heart rate at anaerobic threshold) or 6MWT (for those unable to complete cardiopulmonary exercise tests), with follow-up conducted throughout the period.
Related Therapeutic Areas
Sponsors
Leads: Haiyan Pan

This content was sourced from clinicaltrials.gov