A Phase 4 interventional study of ultrafiltration in Severe Congestive Heart Failure, sponsored by Centro Cardiologico Monzino. Completed at 1 site in Italy. Open to participants aged 20 Years to 90 Years. Per ClinicalTrials.gov, last updated 2016-01-28.
Sponsored by Centro Cardiologico Monzino · Phase 4, Interventional, and Treatment
Patients with severe congestive heart failure show increased fluid body content which is often resistant to conventional diuretic therapy. Therefore, chronic heart failure patients have frequent access to the emergency room and hospital for hemodynamic instability. Ultrafiltration is a simple renal replacement therapy which reduces fluid overload. The purpose of this study is to determine whether periodic ultrafiltration sessions maintain patients in stable clinical condition and reduce hospitalisations as well as access to emergency heart failure treatment.
Patients with severe heart failure (New York Heart Association [NYHA] III-IV) and fluid overload will be randomized to ultrafiltration (UF group) or conventional medical treatment (Control group). Patients follow-up at least monthly visit for one year. Ultrafiltration will be repeated during follow-up in case of body weight gain due to fluid accumulation. Ultrafiltration will be performed during short term hospitalization.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's enrollment of 60 is below the median of 72 across 3,736 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →Centro Cardiologico Monzino is the lead sponsor of 69 studies on the registry; 24 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Ultrafiltration treatment
Procedure: ultrafiltration
Usual HF treatment
Procedure: ultrafiltration
number of hospitalizations for heart failure
Time frame: End of study
long term major adverse clinical events including death
Time frame: End of study
This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.
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Centro Cardiologico Monzino