Clinical trial NCT02846337: Ultrafiltration Versus Medical Therapies in the Management of the Cardio Renal Syndrome
Official title: Ultrafiltration Versus Medical Therapies in the Management of the Cardio Renal Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardio-renal Syndrome
Keywords: cardio-renal syndrome
hemodialysis
peritoneal dialysis
hemofiltration
composite endpoint
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-07-27
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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.

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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.

Primary outcomes:
measure: death and/or unscheduled hospitalization
timeFrame: up to 12 months post-randomization
Secondary outcomes:
measure: Survival
timeFrame: 12 months
measure: Survival
timeFrame: 12 months
measure: Hospitalization for acute decompensated heart failure
timeFrame: up to 12 months post- randomization
measure: Change in NYHA classification
timeFrame: randomization day and 12 months post randomization.
measure: Change in 6MWT - Six-Minute Walk Test
timeFrame: randomization day and 12 months post randomization.
measure: Change in MLwHF form
timeFrame: randomization day and 12 months post randomization.
measure: Change in SF36 form
timeFrame: randomization day and 12 months post randomization.
measure: Death occurrence attributable to ultrafiltration technique
timeFrame: up to 12 months post- randomization
measure: Change in Brain Natriuretic Peptide and/or NT-Probating Natriuretic Peptide rate
timeFrame: randomization day and 12 months post randomization
measure: Change in total bilirubin rate
timeFrame: randomization day, then 3, 6 and 12 months post randomization
measure: Change high-sensitivity T troponin rate
timeFrame: randomization day and 12 months post randomization
measure: Change in hemoglobin rate
timeFrame: randomization day and 12 months post randomization
measure: Change in Left ventricular ejection fraction (LVEF)
timeFrame: randomization day and 12 months post randomization
measure: Change in Tricuspid annular plane systolic excursion (TAPSE)
timeFrame: randomization day and 12 months post randomization
measure: Change in tricuspid annular velocity
timeFrame: randomization day and 12 months post randomization
measure: Change in transmitral patterns classification
timeFrame: randomization day and 12 months post randomization
measure: Change in E/E' ratio
timeFrame: randomization day and 12 months post randomization
measure: Change in pulmonary artery systolic pressure (PASP)
timeFrame: randomization day and 12 months post randomization
measure: Change in Surface of the Left Atrium
timeFrame: randomization day and 12 months post randomization
measure: Change in right atrial pressure
timeFrame: randomization day and 12 months post randomization
measure: Change in cardiac index
timeFrame: randomization day and 12 months post randomization
measure: Change in cardiac flow
timeFrame: randomization day and 12 months post randomization
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hospices Civils de Lyon, Hôpital E Herriot, Service de néphrologie, 5 place d'Arsonval
state: Rhones Alpes
Study officials:
affiliation: Hospices Civils de Lyon, 69002 LYON France
name: Laurent JUILLARD
role: PRINCIPAL_INVESTIGATOR
References: