Clinical Trial: Ultrafiltration Versus Medical Therapies in the Management of the Cardio Renal Syndrome

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Ultrafiltration Versus Medical Therapies in the Management of the Cardio Renal Syndrome

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.

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.



Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Survival [ Time Frame: 12 months ]
    Intervention effect on one-year overall survival
  • Hospitalization for acute decompensated heart failure [ Time Frame: up to 12 months post- randomization ]

    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.
  • Change in NYHA classification [ Time Frame: randomization day and 12 months post randomization. ]
    New York Health Association - Measurement scale to classify heart failure in 4 stages (stage 1 ; no symptoms)
  • Change in 6MWT - Six-Minute Walk Test [ Time Frame: randomization day and 12 months post randomization. ]
    Six-minute walk test with an experimented physiologist. The distance in meters is retained
  • Change in INTERMACS scale [ Time Frame: randomization day and 12 months post randomization. ]
    Interagency Registry For Mechanically Assisted Circulatory - 7 stages classification
  • Change in MLwHF form [ Time Frame: randomization day and 12 months post randomization. ]
    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
  • Change in SF36 form [ Time Frame: randomization day and 12 months post randomization. ]
    Short Form 36 : Quality of life self-administered survey with 36 items about 8 dimensions including a physical and mental score.
  • Number of patients developing end-stage kidney disease [ Time Frame: up to 12 months post- randomization ]
    End-stage kidney disease will be characterized by urea and creatinine kidney clearance below 10ml/min/1.73m². These clearances will be measured from 24 hours blood and urine samples.
  • Death occurrence attributable to ultrafiltration technique [ Time Frame: up to 12 months post- randomization ]
    Safety: Death occurrence attributable to ultrafiltration technique, validated by an independent supervisory board, and any adverse event.
  • Change in Brain Natriuretic Peptide and/or NT-Probating Natriuretic Peptide rate [ Time Frame: randomization day and 12 months post randomization ]
    Following biological features variation : Brain Natriuretic Peptide (BNP) and/or NT-ProBNP
  • Change in total bilirubin rate [ Time Frame: randomization day, then 3, 6 and 12 months post randomization ]
    Following biological features variation : total bilirubin
  • Change high-sensitivity T troponin rate [ Time Frame: randomization day and 12 months post randomization ]
    Following biological features variation : high-sensitivity T troponin
  • Change in hemoglobin rate [ Time Frame: randomization day and 12 months post randomization ]
    Following biological features variation : hemoglobin
  • Change in Left ventricular ejection fraction (LVEF) [ Time Frame: randomization day and 12 months post randomization ]
    Following echocardiographic parameters features : left systolic function (LVEF)
  • Change in Tricuspid annular plane systolic excursion (TAPSE) [ Time Frame: randomization day and 12 months post randomization ]
    Following echocardiographic parameters features :right systolic function (TAPSE)
  • Change in tricuspid annular velocity [ Time Frame: randomization day and 12 months post randomization ]
    Following echocardiographic parameters features : right systolic function assessed by tricuspid annular velocity measured with Pulsed Doppler tissue imaging
  • Change in transmitral patterns classification [ Time Frame: randomization day and 12 months post randomization ]
    Following echocardiographic parameters features : left diastolic function assessed by transmitral patterns classification
  • Change in E/E' ratio [ Time Frame: randomization day and 12 months post randomization ]
    Following echocardiographic parameters feat

    Original Secondary Outcome: Same as current

    Information By: Hospices Civils de Lyon

    Dates:
    Date Received: July 22, 2016
    Date Started: March 31, 2017
    Date Completion: September 2019
    Last Updated: April 5, 2017
    Last Verified: July 2016