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Cardio-renal SyndromeUF-CARENCT02846337

Ultrafiltration Versus Medical Therapies in the Management of the Cardio Renal Syndrome

A study testing ULTRAFILTRATION and ENHANCED MEDICAL TREATMENT in people with Cardio-renal Syndrome, run by Hospices Civils de Lyon at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Type 2 cardio renal syndrome is defined by the occurrence or the exacerbation of a kidney failure induced by a chronic heart failure. Sodium overload is one of the main causes leading to the occurrence or the exacerbation of this syndrome. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cardio-renal Syndrome
What is being tested?
ULTRAFILTRATION and ENHANCED MEDICAL TREATMENT
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
108 participants
Where
1 siteFrance
Study dates
31 Mar 2017to 28 Oct 2021
Phase
Interventional
Are there results?
None posted in the registry

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Severe heart failure with recurring congestive symptoms and at least one the following criteria :
  • At least 2 hospitalization > 24 hours for congestive symptoms among the 12 months before the inclusion, whose latest one was in the 6 months before the inclusion
  • Persistent congestive symptoms throughout 30 days (case history) before the randomization: dyspnea NYHA III or IV, lower limbs edema and/or ascites.
  • Diuretic treatment with at least 250mg furosemide per day (or 6mg bumetanide)during at least 1 month
  • Cardiac medical treatment enhanced by the European cardiology society guidance (except intolerance, and/or contraindication) and according to patient cardiologist.
  • Non terminal kidney disease or failure : estimated glomerular filtration rate (GFR) (CKD-Epi formula) between 20 and 90 mL/min/1.73m² (or GFR estimated between 60 and 90 mL/min/1.73m² with proteinuria and/or hematuria) and urea rate under 50mmol/L

Who cannot join

  • Cardiogenic shock or situations that contraindicate the ultrafiltration technique elsewhere than shock room
  • Patient who already had long course ultrafiltration for more than 3 months, or not available because of end-stage renal failure
  • Biventricular pacemaker implementation, single or dual chamber pacemaker implementation, or defibrillator implementation up to 15 days before the inclusion
  • Vasoactive drugs ambulatory treatment (dobutamine, dopamine, adrenalin, noradrenalin)
  • General condition incompatible with any ultrafiltration techniques
  • Age under 18
Show all 11Show fewer
  • Pregnant or lactating women
  • Law-protected patients
  • Patients that can't submit to the follow-up for geographical, social or mental reasons
  • Unwillingness to be treated by ultrafiltration techniques
  • Patients who don't belong to the national social security system, or similar system.

Trial locations and contacts

1 site in 1 country.

France1 site
  • Hospices Civils de Lyon, Hôpital E Herriot, Service de néphrologie, 5 place d'Arsonval

    Lyon, Rhones Alpes, 69003

Other trials in France

About this study

Type 2 cardio renal syndrome is defined by the occurrence or the exacerbation of a kidney failure induced by a chronic heart failure. Sodium overload is one of the main causes leading to the occurrence or the exacerbation of this syndrome. Some patients have a massive sodium retention on which medications are not effective enough. These patients have no further therapeutic options because of the refractory congestion and a 3-months mortality rate around 15%, frequent rehospitalization (3-months rehospitalization rate at 71%) and an excessively impaired quality of life.

For those refractory heart failure with cardio renal syndrome, nephrology departments resort to non-medication sodium extraction (hemodialysis, peritoneal dialysis, isolated ultrafiltration). Between 2002 and 2008, 927 French patients would have start dialysis in this situation. In 2013, 174 patients start dialysis in 97 dialysis centers. French National Authority of Health recently published new Good Practice Guidance thereupon, strengthened by the increasing number of publications and the widespread use of this technique. There is therefore a consensus among professionals about the benefits of such a technique in those indications. However, bibliographical data are not strong enough to support a strong level of evidence. None of foresight strategies have been compared to others in a proper randomized controlled trial, and there is no clue about any suspected superiority from one strategy to another.

Read more

So far, the investigators propound invasive, expensive and not validated techniques to patients with functional and vital prognosis altered. The investigators think it's essential to prove the efficacy of such an approach. They wish to quantify those techniques impact on rehospitalization, with a consideration for the potential survival impact.

It seems unethical to evaluate separated techniques, taking in account that patients with severe heart failure will switch from one technique to another among their care. It is therefore crucial to validate benefits from an invasive procedure (hemodialysis, peritoneal dialysis, isolated ultrafiltration) compared to a medication-restricted care.

Being tested
ULTRAFILTRATION, ENHANCED MEDICAL TREATMENT
Keywords
cardio-renal syndrome, hemodialysis, peritoneal dialysis, hemofiltration, composite endpoint
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.

  • ULTRAFILTRATIONProcedure or surgery

    Peritoneal dialysis: at least one daily contact, 5 days a week minimum, with a hypertonic solution. Le number of contact et the stasis duration will be decided by the practitioner.

    Hemodialysis: at least one hemodialysis per week, one hemofiltration and/or hemodiafiltration per week, and at least 2 liter of ultrafiltrate extraction per week. In case of serious interdialytic weight gain, and/or hemodynamic unsteadiness, sessions can be up to 6 per weeks. Sessions duration will be adjusted to the needful ultrafiltrate and hemodynamic tolerance.

    Isolated ultrafiltration: at least once a week, and includes an extraction of minimum 2 liter ultrafiltrate in less than 4 hours. It could be done, according to routines and department capacity, on a hemodialysis generator, plasmatic exchange generator, or mobile ultrafiltration device.

  • ENHANCED MEDICAL TREATMENTProcedure or surgery

    • Close cardiologic and nephrologic follow-up, minimum 4 times a year, This incidence matches the heart failure, and chronic kidney failure care guidance for our sample
    • Medical care adjustment in order to apply European and American guidance for chronic heart failure care
    • Hydric, caloric, peptic and sodium input evaluation by a dietician, and adjustment if needed
    • Physical rehabilitation suggestions by a physiologist
    • Evaluation of an interventional approach requirement, and implementation if needed (pacemaker, defibrillator, cardiac resynchronization, diagnosis and therapeutic coronary angiography, ventricular stimulator) according to European and American guidance.
Study groups in NCT02846337
Study groupRoleWhat they receive
ULTRAFILTRATIONExperimentalThe ultrafiltration sodium-overload extraction will be chosen by the patient nephrologist and the patient himself (according to his comorbidities) among the following one: peritoneal dialysis (at least a daily contact), hemodialysis (>1 session per week) or isolated ultrafiltration (>1 session per week). Ultrafiltration technique could change throughout the care
Receives: Procedure: ULTRAFILTRATION
ENHANCED MEDICAL TREATMENTOtherThe control group called "enhanced medical treatment" will not benefit of ultrafiltration (except refractory pulmonary edema, or terminal kidney failure requiring extra renal depuration). These situations will not be considered as protocol violation, because they are scientifically indicated for extra renal depuration.
Receives: Procedure: ENHANCED MEDICAL TREATMENT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. death and/or unscheduled hospitalization

    The primary outcome measure is a combined measure including death whatever the cause, and/or unscheduled hospitalization for acute decompensated heart failure. For each groups, deaths, cause and time of deaths will be recorded. Hospitalization date, duration, location, and reason will be recorded. The "hospitalization" setting and the "acute decompensated heart failure" setting will be endorsed by an event validation committee.

    Measured: up to 12 months post-randomization

Secondary outcomes (22)
  1. Survival

    number of days spent alive and not hospitalized

    Measured: 12 months

  2. Survival

    Intervention effect on one-year overall survival

    Measured: 12 months

  3. Hospitalization for acute decompensated heart failure

    Intervention effect on :

    • Period before first unscheduled hospitalization for acute decompensated heart failure
    • Number and duration of hospitalizations for acute heart failure (scheduled or not) throughout the year
    • Number and duration of unscheduled hospitalization for acute heart failure throughout the year.

    Measured: up to 12 months post- randomization

  4. Change in NYHA classification

    New York Health Association - Measurement scale to classify heart failure in 4 stages (stage 1 ; no symptoms)

    Measured: randomization day and 12 months post randomization.

  5. Change in 6MWT - Six-Minute Walk Test

    Six-minute walk test with an experimented physiologist. The distance in meters is retained.

    Measured: randomization day and 12 months post randomization.

  6. Change in MLwHF form

    Minnesota Living with Heart Failure - Quality of life self-administered survey focusing on heart failure symptoms (21 items with 1 : slightly to 5 : al lot) Safety issue? 0 Yes 1 No

    Measured: randomization day and 12 months post randomization.

  7. Change in SF36 form

    Short Form 36 : Quality of life self-administered survey with 36 items about 8 dimensions including a physical and mental score.

    Measured: randomization day and 12 months post randomization.

  8. Death occurrence attributable to ultrafiltration technique

    Safety: Death occurrence attributable to ultrafiltration technique, validated by an independent supervisory board, and any adverse event.

    Measured: up to 12 months post- randomization

  9. Change in Brain Natriuretic Peptide and/or NT-Probating Natriuretic Peptide rate

    Following biological features variation : Brain Natriuretic Peptide (BNP) and/or NT-ProBNP

    Measured: randomization day and 12 months post randomization

  10. Change in total bilirubin rate

    Following biological features variation : total bilirubin

    Measured: randomization day, then 3, 6 and 12 months post randomization

  11. Change high-sensitivity T troponin rate

    Following biological features variation : high-sensitivity T troponin

    Measured: randomization day and 12 months post randomization

  12. Change in hemoglobin rate

    Following biological features variation : hemoglobin

    Measured: randomization day and 12 months post randomization

  13. Change in Left ventricular ejection fraction (LVEF)

    Following echocardiographic parameters features : left systolic function (LVEF)

    Measured: randomization day and 12 months post randomization

  14. Change in Tricuspid annular plane systolic excursion (TAPSE)

    Following echocardiographic parameters features :right systolic function (TAPSE)

    Measured: randomization day and 12 months post randomization

  15. Change in tricuspid annular velocity

    Following echocardiographic parameters features : right systolic function assessed by tricuspid annular velocity measured with Pulsed Doppler tissue imaging

    Measured: randomization day and 12 months post randomization

  16. Change in transmitral patterns classification

    Following echocardiographic parameters features : left diastolic function assessed by transmitral patterns classification

    Measured: randomization day and 12 months post randomization

  17. Change in E/E' ratio

    Following echocardiographic parameters features : E/E'

    Measured: randomization day and 12 months post randomization

  18. Change in pulmonary artery systolic pressure (PASP)

    Following echocardiographic parameters features : pulmonary artery systolic pressure (PASP)

    Measured: randomization day and 12 months post randomization

  19. Change in Surface of the Left Atrium

    Following echocardiographic parameters features : Surface of the Left Atrium

    Measured: randomization day and 12 months post randomization

  20. Change in right atrial pressure

    Following echocardiographic parameters features : Impact on right ventricular function assessed by right atrial pressure

    Measured: randomization day and 12 months post randomization

  21. Change in cardiac index

    Following echocardiographic parameters features : cardiac index

    Measured: randomization day and 12 months post randomization

  22. Change in cardiac flow

    Following echocardiographic parameters features : cardiac flow

    Measured: randomization day and 12 months post randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jul 2016 (estimated)
  2. Study start31 Mar 2017
  3. Primary completion28 Oct 2021
  4. Study completion28 Oct 2021

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
108 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02846337
Sponsor's protocol ID
69HCL15_0077
Other IDs
2016-A00518-43
Acronym
UF-CARE
Status last verified
Oct 2026
First submitted
22 Jul 2016
Last updated
14 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Schleef M, Sens F, Magaud L, Haesebaert J, Langlois-Jacques C, Juillard L, Bonnefoy E, Baudry G; UF-CARE Study Group. Renal replacement therapy in type 2 severe cardiorenal syndrome: a randomized controlled trial. ESC Heart Fail. 2026 May 9:xvag133. doi: 10.1093/eschf/xvag133. Online ahead of print.

    PubMed 42105307

Questions about this trial

What is this clinical trial studying?

A study testing ULTRAFILTRATION and ENHANCED MEDICAL TREATMENT in people with Cardio-renal 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 6 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: finished, as of the sponsor's last update on 14 Oct 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

death and/or unscheduled hospitalization (time frame: up to 12 months post-randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02846337, which also lists 1 linked publication.

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 14 Oct 2026.

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