Ultrafiltration Versus Medical Therapies in the Management of the Cardio Renal Syndrome — UF-CARE  

Cardio-renal Syndrome Clinical Trial

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

Status Recruiting

Clinical 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. 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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Cardio-renal Syndrome
• Syndrome

• NCT number: NCT02846337
• Study type: Interventional
• Source: Hospices Civils de Lyon
• Contact: Laurent JUILLARD, Pr
• Phone: (0)472 110 159
• Email: laurent.juillard@chu-lyon.fr
• Status: Recruiting
• Phase: N/A
• Start date: March 31, 2017
• Completion date: September 30, 2021