Cardiorenal SyndromeNCT07167368
Exercise Rehabilitation for Cardiorenal Syndrome in HFrEF Patients
A study testing Standardized Basic Drug Therapy for HFrEF with Chronic Kidney Dysfunction and Home-based Personalized Exercise Rehabilitation in people with Cardiorenal Syndrome, run by Haiyan Pan at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cardiorenal Syndrome
- What is being tested?
- Standardized Basic Drug Therapy for HFrEF with Chronic Kidney Dysfunction and Home-based Personalized Exercise Rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 15 Sep 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- Severe anemia
- Abnormal thyroid function
- Severe pulmonary diseases
- Mental illnesses
- Osteoarticular or muscular diseases that impede rehabilitation training
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Affiliated Hospital of Nantong University
Nantong, Jiangsu
Pan, +86 13906291842, dr.phy@qq.com
About this study
Official title: 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
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.
Read more
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.
Read the detailed description
This study is designed to evaluate the efficacy and safety of home-based exercise rehabilitation as an adjuvant intervention for patients with Cardiorenal Syndrome (CRS) complicated by Chronic Heart Failure with Reduced Ejection Fraction (HFrEF). Building on prior evidence that exercise rehabilitation improves cardiac function and cardiopulmonary endurance in patients with uncomplicated chronic heart failure, this study addresses a critical gap: the lack of data on how such interventions perform in CRS, a condition characterized by bidirectional cardiorenal impairment that often exacerbates both cardiac and renal dysfunction.
CRS patients with HFrEF typically exhibit reduced cardiopulmonary reserve, as evidenced by lower peak oxygen uptake (VO₂ peak) and 6-minute walk test (6MWT) distance compared to non-CRS patients. This impairment is driven by intertwined pathophysiological mechanisms, including neurohormonal activation, systemic inflammation, and reduced renal clearance of cardiotoxic metabolites-factors that may be modulated by structured exercise. The home-based exercise approach is selected for its clinical relevance: it aligns with long-term patient adherence (avoiding barriers to clinic-based training, such as transportation or scheduling) and allows for personalized intensity adjustments, a key safety consideration in patients with dual organ dysfunction.
Exercise prescriptions for the intervention group are tailored using a two-step assessment protocol to ensure safety and individualization:
- Cardiopulmonary Exercise Test (CPET): For patients able to complete CPET (per exercise risk assessment), the anaerobic threshold (AT) is identified via gas exchange analysis (using a metabolic cart). Exercise intensity is set at 60-70% of the heart rate corresponding to AT (HR-AT)-a range validated to improve cardiopulmonary endurance without inducing excessive cardiac or renal stress in HFrEF patients.
- 6MWT Alternative: For patients unable to complete CPET (e.g., due to severe dyspnea or fatigue), exercise intensity is derived from 6MWT results. The target walking speed is set at 70-80% of the average speed achieved during the 6MWT, with duration adjusted to match energy expenditure levels equivalent to the CPET-derived protocol.
The 6-month exercise program focuses on aerobic training (e.g., brisk walking, stationary cycling) with progressive adjustments: initial sessions are 20-30 minutes, 3 times weekly, with 5-10 minute increments in duration (up to 45 minutes) and 5-10% increments in intensity every 2 weeks, based on patient-reported tolerance (assessed via the Borg Rating of Perceived Exertion scale, 0-10) and monthly follow-up monitoring.
To mitigate intervention-related risks, all participants undergo monthly remote or in-clinic follow-up:
- Vital Sign Checks: Resting heart rate, blood pressure, and body weight (to monitor fluid retention, a marker of renal or cardiac decompensation) are recorded at each visit.
- Adverse Event Tracking: Any cardiac (e.g., angina, arrhythmia), renal (e.g., acute kidney injury), or musculoskeletal events are documented using standardized clinical definitions, with protocol adjustments (e.g., temporary exercise pause, intensity reduction) implemented as needed.
This design ensures that the intervention is both mechanistically targeted to CRS pathophysiology and practically feasible for long-term patient engagement, while prioritizing safety in a vulnerable patient population.
- Conditions
- Cardiorenal Syndrome
- Being tested
- Standardized Basic Drug Therapy for HFrEF with Chronic Kidney Dysfunction, Home-based Personalized Exercise Rehabilitation
- Medical subject headings
- Cardio-Renal Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized Basic Drug Therapy for HFrEF with Chronic Kidney DysfunctionDrug
Also called Guideline-Based Basic Medication Regimen for CRS Patients with HFrEF
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.
Home-based Personalized Exercise RehabilitationBehavioural
Also called Home-Centered Customized Exercise Program for CRS with HFrEF
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Standardized Basic Drug Therapy for HFrEF with Chronic Kidney Dysfunction; Behavioral: Home-based Personalized Exercise Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: At baseline and 6 months after treatment initiation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start15 Sep 2025
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiorenal SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haiyan Pan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Haiyan Pan, Affiliated Hospital of Nantong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07167368
- Sponsor's protocol ID
- 2025-K124-01-B
- Status last verified
- Feb 2026
- First submitted
- 18 Aug 2025
- Last updated
- 27 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07167368
- Acronym / sponsor ID
- 2025-K124-01-B
- Conditions
- Cardiorenal Syndrome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Haiyan PanUniversity, hospital or other
- Study start
- 15 Sep 2025 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 11 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is designed to evaluate the efficacy and safety of home-based exercise rehabilitation as an adjuvant intervention for patients with Cardiorenal Syndrome (CRS) complicated by Chronic Heart Failure with Reduced Ejection Fraction (HFrEF). Building on prior evidence that exercise rehabilitation improves cardiac function and cardiopulmonary endurance in patients with uncomplicated chronic heart failure, this study addresses a critical gap: the lack of data on how such interventions perform in CRS, a condition characterized by bidirectional cardiorenal impairment that often exacerbates both cardiac and renal dysfunction.
CRS patients with HFrEF typically exhibit reduced cardiopulmonary reserve, as evidenced by lower peak oxygen uptake (VO₂ peak) and 6-minute walk test (6MWT) distance compared to non-CRS patients. This impairment is driven by intertwined pathophysiological mechanisms, including neurohormonal activation, systemic inflammation, and reduced renal clearance of cardiotoxic metabolites-factors that may be modulated by structured exercise. The home-based exercise approach is selected for its clinical relevance: it aligns with long-term patient adherence (avoiding barriers to clinic-based training, such as transportation or scheduling) and allows for personalized intensity adjustments, a key safety consideration in patients with dual organ dysfunction.
Exercise prescriptions for the intervention group are tailored using a two-step assessment protocol to ensure safety and individualization:
- Cardiopulmonary Exercise Test (CPET): For patients able to complete CPET (per exercise risk assessment), the anaerobic threshold (AT) is identified via gas exchange analysis (using a metabolic cart). Exercise intensity is set at 60-70% of the heart rate corresponding to AT (HR-AT)-a range validated to improve cardiopulmonary endurance without inducing excessive cardiac or renal stress in HFrEF patients.
- 6MWT Alternative: For patients unable to complete CPET (e.g., due to severe dyspnea or fatigue), exercise intensity is derived from 6MWT results. The target walking speed is set at 70-80% of the average speed achieved during the 6MWT, with duration adjusted to match energy expenditure levels equivalent to the CPET-derived protocol.
The 6-month exercise program focuses on aerobic training (e.g., brisk walking, stationary cycling) with progressive adjustments: initial sessions are 20-30 minutes, 3 times weekly, with 5-10 minute increments in duration (up to 45 minutes) and 5-10% increments in intensity every 2 weeks, based on patient-reported tolerance (assessed via the Borg Rating of Perceived Exertion scale, 0-10) and monthly follow-up monitoring.
To mitigate intervention-related risks, all participants undergo monthly remote or in-clinic follow-up:
- Vital Sign Checks: Resting heart rate, blood pressure, and body weight (to monitor fluid retention, a marker of renal or cardiac decompensation) are recorded at each visit.
- Adverse Event Tracking: Any cardiac (e.g., angina, arrhythmia), renal (e.g., acute kidney injury), or musculoskeletal events are documented using standardized clinical definitions, with protocol adjustments (e.g., temporary exercise pause, intensity reduction) implemented as needed.
This design ensures that the intervention is both mechanistically targeted to CRS pathophysiology and practically feasible for long-term patient engagement, while prioritizing safety in a vulnerable patient population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Basic Treatment Group | Active comparator | Drug: Standardized Basic Drug Therapy for HFrEF with Chronic Kidney DysfunctionPatients with HFrEF and chronic kidney dysfunction receive 6 months of basic drug treatment, with regular follow-up during the period. |
| Exercise Rehabilitation Group | Experimental | Drug: Standardized Basic Drug Therapy for HFrEF with Chronic Kidney Dysfunction, Behavioral: Home-based Personalized Exercise RehabilitationPatients 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standardized Basic Drug Therapy for HFrEF with Chronic Kidney DysfunctionAlso: Guideline-Based Basic Medication Regimen for CRS Patients with HFrEFParticipants 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. | Drug | Basic Treatment Group, Exercise Rehabilitation Group |
| Home-based Personalized Exercise RehabilitationAlso: Home-Centered Customized Exercise Program for CRS with HFrEFOn 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. | Behavioural | Exercise Rehabilitation Group |
Primary outcome
Difference in VO₂ peak (a marker of cardiopulmonary exercise tolerance) between the two groups before and after 6 months of treatment
Time frame: At baseline and 6 months after treatment initiation.
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.
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
Time frame: At baseline and 6 months after treatment initiation.
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).
Differences in estimated Glomerular Filtration Rate (eGFR) between the two groups before and after 6 months of treatment
Time frame: At baseline and 6 months after treatment initiation.
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).
Difference in Serum Creatinine (Scr) between the two groups before and after 6 months of treatment
Time frame: At baseline and 6 months after treatment initiation.
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).
Difference in Left Ventricular Ejection Fraction (LVEF) between the two groups before and after 6 months of treatment
Time frame: At baseline and 6 months after treatment initiation.
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.
4 secondary outcomes
Difference in N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels between the two groups before and after 6 months of treatment
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: At baseline and 6 months after treatment initiation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standardized Basic Drug Therapy for HFrEF with Chronic Kidney Dysfunction and Home-based Personalized Exercise Rehabilitation in people with Cardiorenal Syndrome, run by Haiyan Pan at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in VO₂ peak (a marker of cardiopulmonary exercise tolerance) between the two groups before and after 6 months of treatment (time frame: At baseline and 6 months after treatment initiation.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.