RecruitingNot ApplicableNCT07167368

Exercise Rehabilitation for Cardiorenal Syndrome in HFrEF Patients

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


Sponsor

Haiyan Pan

Enrollment

60 participants

Start Date

Sep 15, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria4

  • 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

Exclusion Criteria11

  • 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
  • Deep vein thrombosis or pulmonary embolism
  • History of syncope
  • Severe anemia
  • Abnormal thyroid function
  • Severe pulmonary diseases
  • Mental illnesses
  • Osteoarticular or muscular diseases that impede rehabilitation training

Interventions

DRUGStandardized Basic Drug Therapy for HFrEF with Chronic Kidney Dysfunction

Participants receive standardized basic drug therapy for HFrEF and chronic kidney dysfunction in accordance with clinical practice guidelines. Medications include but are not limited to angiotensin-converting enzyme inhibitors (ACEIs), angiotensin receptor blockers (ARBs), beta-blockers, mineralocorticoid receptor antagonists (MRAs), and diuretics, with dosage adjustments based on individual patient conditions.

BEHAVIORALHome-based Personalized Exercise Rehabilitation

On the basis of basic drug treatment, participants in the exercise rehabilitation group receive personalized home-based exercise prescriptions. Prescriptions are developed according to cardiopulmonary exercise test results (using heart rate at anaerobic threshold) or 6MWT (for those unable to complete cardiopulmonary exercise tests). The 6-month exercise program includes aerobic exercises (e.g., brisk walking, cycling), with intensity, duration, and frequency adjusted based on individual tolerance and progress.


Locations(1)

The Affiliated Hospital of Nantong University

Nantong, Jiangsu, China

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NCT07167368


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