Cardiorenal Syndrome: Characteristics and Prognostic Impact in Advanced Heart Failure
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHospices Civils de Lyon
About this trial
Advanced heart failure (AHF) represents the end stage of chronic heart failure with reduced ejection fraction and affects up to 10% of patients with heart failure. These patients have refractory disease despite optimal guideline-directed medical therapy, and their management is discussed within a multidisciplinary "Heart Team".
Renal dysfunction is highly prevalent in this population. The coexistence of cardiac and renal dysfunction has been classified under the entity of cardiorenal syndrome. Impaired renal function is an independent predictor of adverse cardiovascular and renal outcomes, including death, heart failure decompensation, worsening renal function, and the need for renal replacement therapy. However, patients with AHF remain a particularly complex population, and the lack of longitudinal biological data and limited understanding of the dynamics of cardiorenal syndrome in relation to therapeutic interventions make prognosis assessment and individualized management challenging.
In addition, little is known about renal tubular function in AHF, despite its central role in hydro-electrolytic balance regulation. Biomarkers of tubular injury such as neutrophil gelatinase-associated lipocalin (NGAL) and kidney injury molecule-1 (KIM-1) have shown prognostic value in therapeutic studies, but their relationship with cardiac function and outcomes in advanced heart failure remains insufficiently characterized.
The primary objective of this study is to evaluate renal function parameters and their evolution over time through measurement of glomerular filtration rate (GFR) and assessment of tubular function in patients with advanced heart failure, and to investigate their association with major adverse cardiovascular events.
This is a prospective, single-center RIPH2 cohort study including 100 patients aged 18 to 75 years managed for advanced heart failure at the Louis Pradel Cardiovascular Hospital (Hospices Civils de Lyon, France). Patients will be followed according to standard care at 6, 12, 18, and 24 months. More comprehensive nephrological and cardiological evaluations will be performed at baseline, 12 months, and 24 months. Biobanking and quality-of-life questionnaires will also be conducted during these visits. Blood and urine samples will be collected at baseline and 12 months for NGAL et KIM-1 analysis. In addition, a subgroup of 50 consenting patients without contraindications will undergo multiparametric non-contrast renal MRI combined with tissue sodium quantification using 23Na MRI of the leg.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Written informed consent signed by the patient,
Age ≥ 18 years and ≤ 75 years,
LVEF ≤ 35%,
Elevated BNP or NT-proBNP levels (>200 ng/L for BNP and >1000 ng/L for NT-proBNP),
Disqualifiers
Presence of severe extracardiac disease with a life expectancy < 1 year,
Patient with end-stage renal disease (GFR <15 mL/min/1.73 m²) or on dialysis,
History of heart, kidney, or other solid organ transplantation,
Patient in cardiogenic shock,
Trial design
Design model
Single group
Treatments tested in this trial
Cardiorenal syndrome follow-up
Other interventionPatients with cardiorenal syndrome will be followed for 2 years in nephrology and cardiology according to standard of care. In addition, as part of the research, they will complete quality-of-life questionnaires and provide blood, urine, and stool samples for testing and biobanking. An MRI will also be performed for patients participating in the ancillary study.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Patients with cardiorenal syndromeExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Occurrence of major cardiovascular events during the first 24 months
The primary endpoint of this study is the occurrence of major cardiovascular events during the first 24 months: all-cause mortality, heart transplantation, implantation of a ventricular assist device, hospitalization for heart failure, or worsening ambulatory heart failure. The association between baseline renal function parameters (GFR, NGA, and KIM-1) and the occurrence of events during the first 24 months will be evaluated, as well as the association between renal function parameters at 12 months and the occurrence of major cardiovascular events between 12 and 24 months.
Time frame
At 12 and 24 monthsSecondary outcomes
1
Blood and urinary levels of NGAL and KIM-1
Blood and urinary measurement of NGAL (neutrophil gelatinase-associated lipocalin) and KIM-1 (kidney injury molecule-1),
Time frame
at baseline and at 12 months2
Occurrence of major adverse renal events
Occurrence of major adverse renal events during the first 24 months: persistent (\>30 days) decline in glomerular filtration rate of \>40%, initiation of renal replacement therapy, or death due to renal causes. The association between baseline GFR and the occurrence of adverse renal events during the first 24 months will be evaluated, as well as the association between changes in GFR between baseline and 12 months and the occurrence of adverse renal events between 12 and 24 months. Occurrence of major adverse renal events during the first 24 months: persistent (\>30 days) decline in glomerular filtration rate of \>40%, initiation of renal replacement therapy, or death due to renal causes. The association between baseline GFR and the occurrence of adverse renal events during the first 24 months will be evaluated, as well as the association between changes in GFR between baseline and 12 months and the occurrence of adverse renal events between 12 and 24 months.
Time frame
at baseline, 12 and 24 months3
Occurrence of heart failure decompensation events
Occurrence of heart failure decompensation events (hospitalization, ventricular assist device implantation, or outpatient worsening) during the first 24 months. The association between specific biomarkers of renal tubular injury (serum and urinary NGAL and KIM-1) at baseline and heart failure decompensation events during the first 24 months will be analysed, as well as the association between changes in specific biomarkers of renal tubular injury between baseline and 12 months and the occurrence of heart failure decompensation events between 12 and 24 months.
Time frame
at baseline, 12 and 24 months4
Clinical data collected over a 24-month follow-up period
Description of the study population over 24 months of follow-up (clinical, paraclinical, therapeutic characteristics, and serious adverse events),
Time frame
over 24 monthsSponsors and contacts
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Source ClinicalTrials.gov
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