Advanced Heart FailureCARAVELNCT07666516
Cardiorenal Syndrome: Characteristics and Prognostic Impact in Advanced Heart Failure
A study testing Cardiorenal syndrome follow-up in people with Advanced Heart Failure and Cardiorenal Syndrome, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Heart Failure, Cardiorenal Syndrome
- What is being tested?
- Cardiorenal syndrome follow-up
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2026to 15 Nov 2031
- 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
- 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.
Who cannot join
- 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*,
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- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Hospices Civils de Lyon
Bron, Rhone, 69500
Nathan MEWTON, Pr, 04 72 35 71 70 ext. +33, nathan.mewton@chu-lyon.fr
About this study
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.
Read more
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.
- Conditions
- Advanced Heart Failure, Cardiorenal Syndrome
- Being tested
- Cardiorenal syndrome follow-up
- Keywords
- advanced heart failure, cardiorenal syndrome, biomarkers
- 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.
Cardiorenal syndrome follow-upOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with cardiorenal syndrome | Experimental | Patients with cardiorenal syndrome will be followed for 2 years in nephrology and cardiology according to standard of care. Receives: Other: Cardiorenal syndrome follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 12 and 24 months
Secondary outcomes (9)
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),
Measured: at baseline and at 12 months
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.
Measured: at baseline, 12 and 24 months
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.
Measured: at baseline, 12 and 24 months
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),
Measured: over 24 months
Score of KCCQ questionnaire
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.
Measured: at baseline, and at 6, 12, 18, and 24 months
Score of Morisky self-questionnaire MMAS-4
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.
Measured: at baseline, and at 6, 12, 18, and 24 months,
Biomarkers identification
IBiomarkers identification in biological samples collected in the study biocollection.
Measured: At baseline, 12 months and 24 months
Multiparametric renal MRI
Multiparametric renal MRI (BOLD, diffusion, T1 and T2 mapping) in a subgroup of 50 voluntary patients (optional examination)
Measured: at baseline and at 12 months
Tissue sodium measurement
Tissue sodium measurement using 23Na MRI of the leg in a subgroup of 50 voluntary patients (optional examination)
Measured: at baseline and at 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study start1 Sep 2026 (estimated)
- Primary completion15 Nov 2031 (estimated)
- Study completion15 Nov 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Heart FailureStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07666516
- Sponsor's protocol ID
- 69HCL20_0968
- Acronym
- CARAVEL
- Status last verified
- Jun 2026
- First submitted
- 4 Jun 2026
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiorenal Syndrome: Characteristics and Prognostic Impact in Advanced Heart Failure
- ClinicalTrials.gov ID
- NCT07666516
- Acronym / sponsor ID
- CARAVEL / 69HCL20_0968
- Conditions
- Advanced Heart Failure, Cardiorenal Syndrome
- Keywords
- advanced heart failure, cardiorenal syndrome, biomarkers
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 15 Nov 2031 (estimated)
- Study completion
- 15 Nov 2031 (estimated)
- First posted
- 24 Jun 2026 (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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with cardiorenal syndrome | Experimental | Other: Cardiorenal syndrome follow-upPatients with cardiorenal syndrome will be followed for 2 years in nephrology and cardiology according to standard of care. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
- NYHA class ≥ 3,
- At least one hospitalization for heart failure decompensation within the past 24 months,
Key exclusion criteria (12 listed)
- 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,
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 |
|---|---|---|
| Cardiorenal syndrome follow-upPatients 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. | Other | Patients with cardiorenal syndrome |
Primary outcome
Occurrence of major cardiovascular events during the first 24 months
Time frame: 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.
9 secondary outcomes
Blood and urinary levels of NGAL and KIM-1
Time frame: at baseline and at 12 months
Occurrence of major adverse renal events
Time frame: at baseline, 12 and 24 months
Occurrence of heart failure decompensation events
Time frame: at baseline, 12 and 24 months
Clinical data collected over a 24-month follow-up period
Time frame: over 24 months
Score of KCCQ questionnaire
Time frame: at baseline, and at 6, 12, 18, and 24 months
Score of Morisky self-questionnaire MMAS-4
Time frame: at baseline, and at 6, 12, 18, and 24 months,
Biomarkers identification
Time frame: At baseline, 12 months and 24 months
Multiparametric renal MRI
Time frame: at baseline and at 12 months
Tissue sodium measurement
Time frame: at baseline and at 12 months.
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 1 Jul 2026.
- Individual participant dataSharing planned: No
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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 Cardiorenal syndrome follow-up in people with Advanced Heart Failure and Cardiorenal Syndrome, run by Hospices Civils de Lyon at 1 site in France.
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 8 inclusion and 12 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: opening soon, as of the sponsor's last update on 1 Jul 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 France. 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?
Contact Nathan MEWTON, Pr (04 72 35 71 70 ext. +33, nathan.mewton@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of major cardiovascular events during the first 24 months (time frame: At 12 and 24 months). 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 1 Jul 2026.