Exercise Rehabilitation for Cardiorenal Syndrome in HFrEF Patients

NCT07167368 | Recruiting

• 1 other identifier: 2025-K124-01-B
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiorenal Syndrome

Outcome Measures

Primary Outcomes (5)

• 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.

  At baseline and 6 months after treatment initiation.

• 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).

  At baseline and 6 months after treatment initiation.

• 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).

  At baseline and 6 months after treatment initiation.

• 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).

  At baseline and 6 months after treatment initiation.

• Difference in Left Ventricular Ejection Fraction (LVEF) between the two groups before and after 6 months of treatment

  Compare the change in Left Ventricular Ejection Fraction (LVEF) between the Exercise Rehabilitation Group and the Basic Treatment Group.Measurement name: Left Ventricular Ejection Fraction (LVEF).Measurement tool: Transthoracic Echocardiography (TTE, standard clinical ultrasound examination).Unit of measure: Percentage (%).Outcome interpretation: Higher LVEF values indicate better left ventricular systolic function (normal range: 50%-70% in adults); changes in LVEF reflect the intervention's effect on cardiac contractile function.LVEF will be measured via TTE at baseline (before treatment initiation) and 6 months after treatment initiation.

  At baseline and 6 months after treatment initiation.

Secondary Outcomes (4)

• Difference in N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels between the two groups before and after 6 months of treatment

  At baseline and 6 months after treatment initiation.

• Difference in cystatin C (Cys-C) levels between the two groups before and after 6 months of treatment

  At baseline and 6 months after treatment initiation.

• Difference in high-sensitivity C-reactive protein (hs-CRP) levels between the two groups before and after 6 months of treatment

  At baseline and 6 months after treatment initiation.

• Differences in scores of the Minnesota Living with Heart Failure Questionnaire between the two groups before and after 6 months of treatment

  At baseline and 6 months after treatment initiation.

Study Arms (2)

Basic Treatment Group

ACTIVE COMPARATOR

Patients with HFrEF and chronic kidney dysfunction receive 6 months of basic drug treatment, with regular follow-up during the period.

Drug: Standardized Basic Drug Therapy for HFrEF with Chronic Kidney Dysfunction

Exercise Rehabilitation Group

EXPERIMENTAL

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.

Drug: Standardized Basic Drug Therapy for HFrEF with Chronic Kidney Dysfunction; Behavioral: Home-based Personalized Exercise Rehabilitation

Interventions

Home-based Personalized Exercise Rehabilitation BEHAVIORAL

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.

Also known as: Home-Centered Customized Exercise Program for CRS with HFrEF

Exercise Rehabilitation Group

Standardized Basic Drug Therapy for HFrEF with Chronic Kidney Dysfunction DRUG

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.

Also known as: Guideline-Based Basic Medication Regimen for CRS Patients with HFrEF

Basic Treatment Group; Exercise Rehabilitation Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Haiyan Pan: lead

Study Sites (1)

The Affiliated Hospital of Nantong University

Nantong, Jiangsu, China

RECRUITING

MeSH Terms

Conditions

Cardio-Renal Syndrome

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Heart Failure; Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor and Chief Physician, Department of Cardiology

Study Record Dates

• First Submitted: August 18, 2025
• First Posted: September 11, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

CN (1)