Exercise Rehabilitation for Cardiorenal Syndrome in HFrEF Patients
ConditionCardiorenal Syndrome
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHaiyan Pan
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Standardized Basic Drug Therapy for HFrEF with Chronic Kidney Dysfunction
DrugParticipants 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.
Home-based Personalized Exercise Rehabilitation
BehavioralOn 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Basic Treatment GroupActive comparator 1 intervention
Group B: Exercise Rehabilitation GroupExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Difference in VO₂ peak (a marker of cardiopulmonary exercise tolerance) between the two groups before and after 6 months of treatment
Compare the change in peak oxygen uptake (VO₂ peak, unit: mL/kg/min) between the Exercise Rehabilitation Group and the Basic Treatment Group. VO₂ peak will be measured via cardiopulmonary exercise test at baseline (before treatment initiation) and 6 months after treatment initiation to assess changes in cardiopulmonary exercise tolerance.
Time frame
At baseline and 6 months after treatment initiation.2
Difference in 6-minute walk test (6MWT) distance (a marker of cardiopulmonary exercise tolerance) between the two groups before and after 6 months of treatment
Compare the change in 6MWT distance (unit: meters) between the Exercise Rehabilitation Group and the Basic Treatment Group. 6MWT will be conducted according to standard clinical protocols at baseline (before treatment initiation) and 6 months after treatment initiation to evaluate changes in functional exercise capacity (a key component of cardiopulmonary exercise tolerance).
Time frame
At baseline and 6 months after treatment initiation.3
Differences in estimated Glomerular Filtration Rate (eGFR) between the two groups before and after 6 months of treatment
Compare the changes in eGFR (a key indicator of overall renal filtration function) between the Exercise Rehabilitation Group and Basic Treatment Group, to assess the intervention's effect on renal filtration function. Higher eGFR values indicate better renal filtration function. Measurement Details: eGFR (unit: mL/min/1.73m²), calculated via the CKD-EPI equation using serum creatinine values measured by standard clinical laboratory biochemical analysis (e.g., enzymatic method).
Time frame
At baseline and 6 months after treatment initiation.4
Difference in Serum Creatinine (Scr) between the two groups before and after 6 months of treatment
Compare the changes in Scr (a marker of renal excretory function) between the Exercise Rehabilitation Group and Basic Treatment Group, to assess the intervention's effect on renal excretory function. Higher Scr values typically indicate impaired renal excretory function. Measurement Details: Scr (unit: μmol/L), measured via standard clinical laboratory biochemical analysis (e.g., picric acid method or enzymatic method).
Time frame
At baseline and 6 months after treatment initiation.Secondary outcomes
1
Difference in N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels between the two groups before and after 6 months of treatment
Compare the change in N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels between the Exercise Rehabilitation Group and the Basic Treatment Group. Measurement name: N-terminal pro-B-type natriuretic peptide (NT-proBNP) Measurement tool: Standard laboratory immunoassay (e.g., chemiluminescent immunoassay) Unit of measure: Picograms per milliliter (pg/mL) Outcome interpretation: NT-proBNP is a marker of cardiac wall stress and heart failure severity; lower levels indicate improved cardiac load and reduced heart failure burden. Levels will be measured via venous blood sampling at baseline (before treatment initiation) and 6 months after treatment initiation.
Time frame
At baseline and 6 months after treatment initiation.2
Difference in cystatin C (Cys-C) levels between the two groups before and after 6 months of treatment
Compare the change in cystatin C (Cys-C) levels between the Exercise Rehabilitation Group and the Basic Treatment Group. Measurement name: Cystatin C (Cys-C) Measurement tool: Standard laboratory immunoassay (e.g., particle-enhanced turbidimetric immunoassay) Unit of measure: Milligrams per liter (mg/L) Outcome interpretation: Cys-C is a sensitive marker of early renal function impairment; lower levels indicate better glomerular filtration function. Levels will be measured via venous blood sampling at baseline (before treatment initiation) and 6 months after treatment initiation.
Time frame
At baseline and 6 months after treatment initiation.3
Difference in high-sensitivity C-reactive protein (hs-CRP) levels between the two groups before and after 6 months of treatment
Compare the change in high-sensitivity C-reactive protein (hs-CRP) levels between the Exercise Rehabilitation Group and the Basic Treatment Group. Measurement name: High-sensitivity C-reactive protein (hs-CRP) Measurement tool: Standard laboratory immunoassay (e.g., latex-enhanced immunoturbidimetry) Unit of measure: Milligrams per liter (mg/L) Outcome interpretation: hs-CRP is a marker of systemic inflammation (closely associated with CRS progression); lower levels indicate reduced inflammatory burden and potential slowing of cardiorenal damage. Levels will be measured via venous blood sampling at baseline (before treatment initiation) and 6 months after treatment initiation.
Time frame
At baseline and 6 months after treatment initiation.4
Differences in scores of the Minnesota Living with Heart Failure Questionnaire between the two groups before and after 6 months of treatment
Compare the change in scores of the Minnesota Living with Heart Failure Questionnaire (MLHFQ) between the Exercise Rehabilitation Group and the Basic Treatment Group, to evaluate the intervention's impact on patients' heart failure-related quality of life. Unabbreviated scale title: Minnesota Living with Heart Failure Questionnaire Score range: Minimum value = 0 points, Maximum value = 105 points Outcome interpretation: Higher scores indicate worse quality of life (reflecting more severe heart failure symptoms, greater functional limitations, and increased emotional distress related to the disease); lower scores indicate better quality of life. The questionnaire will be completed by participants independently (with researcher assistance if needed for clarity) at baseline (before treatment initiation) and 6 months after treatment initiation, following standard administration guidelines.
Time frame
At baseline and 6 months after treatment initiation.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Haiyan Pan
Lead sponsor
Affiliated Hospital of Nantong University
Sponsor institution
Source ClinicalTrials.gov