Ta strona została przetłumaczona automatycznie i dokładność tłumaczenia nie jest gwarantowana. Proszę odnieść się do angielska wersja za tekst źródłowy.

Cardiorenal Syndrome: Characteristics and Prognostic Impact in Advanced Heart Failure (CARAVEL)

29 czerwca 2026 zaktualizowane przez: Hospices Civils de Lyon

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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Szacowany)

100

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

  • Francja
    • Rhone
      • Bron, Rhone, Francja, 69500

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

Inclusion Criteria:

  • Written informed consent signed by the patient,
  • Age ≥ 18 years and ≤ 75 years,

  • Patient with advanced heart failure confirmed by criteria of severe cardiac dysfunction documented in a stable condition, with at least one of the following parameters at baseline:

    • LVEF ≤ 35%,
    • Elevated BNP or NT-proBNP levels (>200 ng/L for BNP and >1000 ng/L for NT-proBNP),
  • NYHA class ≥ 3,
  • At least one hospitalization for heart failure decompensation within the past 24 months,
  • Optimized medical treatment for heart failure according to French/European cardiology guidelines at the maximum tolerated dose for >30 days.

Exclusion Criteria:

  • 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,
  • INTERMACS profile ≤ 3,
  • Pregnant, parturient, or breastfeeding women*,
  • Individuals deprived of liberty by judicial or administrative decision,
  • Individuals under psychiatric care,
  • Individuals admitted to a health or social institution for purposes other than research,
  • Adults under legal protection (guardianship or curatorship),
  • Individuals not affiliated with a social security system or equivalent coverage.
  • Contraindication to multiparametric renal MRI combined with tissue sodium measurement using non-contrast 23Na MRI of the leg (including inability to undergo MRI as judged by the investigator).

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Inny
  • Przydział: Nie dotyczy
  • Model interwencyjny: Zadanie dla jednej grupy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Patients with cardiorenal syndrome
Patients with cardiorenal syndrome will be followed for 2 years in nephrology and cardiology according to standard of care.
Inny: Cardiorenal syndrome follow-up
Patients 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Occurrence of major cardiovascular events during the first 24 months
Ramy czasowe: At 12 and 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.
At 12 and 24 months

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Blood and urinary levels of NGAL and KIM-1
Ramy czasowe: at baseline and at 12 months
Blood and urinary measurement of NGAL (neutrophil gelatinase-associated lipocalin) and KIM-1 (kidney injury molecule-1),
at baseline and at 12 months
Occurrence of major adverse renal events
Ramy czasowe: at baseline, 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.

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.
at baseline, 12 and 24 months
Occurrence of heart failure decompensation events
Ramy czasowe: at baseline, 12 and 24 months
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.
at baseline, 12 and 24 months
Clinical data collected over a 24-month follow-up period
Ramy czasowe: over 24 months
Description of the study population over 24 months of follow-up (clinical, paraclinical, therapeutic characteristics, and serious adverse events),
over 24 months
Score of KCCQ questionnaire
Ramy czasowe: at baseline, and at 6, 12, 18, and 24 months
Each item of KCCQ questionnaire is scored on a 5-point Likert scale and transformed to a 0-100 scale, with higher scores indicating better health status.
at baseline, and at 6, 12, 18, and 24 months
Biomarkers identification
Ramy czasowe: At baseline, 12 months and 24 months
IBiomarkers identification in biological samples collected in the study biocollection.
At baseline, 12 months and 24 months
Multiparametric renal MRI
Ramy czasowe: at baseline and at 12 months
Multiparametric renal MRI (BOLD, diffusion, T1 and T2 mapping) in a subgroup of 50 voluntary patients (optional examination)
at baseline and at 12 months
Tissue sodium measurement
Ramy czasowe: at baseline and at 12 months.
Tissue sodium measurement using 23Na MRI of the leg in a subgroup of 50 voluntary patients (optional examination)
at baseline and at 12 months.
Score of Morisky self-questionnaire MMAS-4
Ramy czasowe: at baseline, and at 6, 12, 18, and 24 months,
Morisky self-questionnaire MMAS-4 is a generic patient-reported questionnaire used to assess medication adherence. The scale consists of four items, each scored as 0 for "Yes" and 1 for "No". The item scores are summed to yield a total score ranging from 0 to 4. Higher scores indicate better medication adherence.
at baseline, and at 6, 12, 18, and 24 months,

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Hospices Civils de Lyon

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 września 2026

Zakończenie podstawowe (Szacowany)

15 listopada 2031

Ukończenie studiów (Szacowany)

15 listopada 2031

Daty rejestracji na studia

Pierwszy przesłany

4 czerwca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

22 czerwca 2026

Pierwszy wysłany (Rzeczywisty)

24 czerwca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

1 lipca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

29 czerwca 2026

Ostatnia weryfikacja

1 czerwca 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 69HCL20_0968

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Subskrybuj