NCT00360958

Treatment of Severe Heart Failure by Ultrafiltration

Ultrafiltration for the Chronic Treatment of Severe Congestive Heart Failure

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Centro Cardiologico Monzino · Academic / Other
• Sex: All
• Age: 20 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Severe Congestive Heart Failure

Interventions

Type	Name	Description
PROCEDURE	ultrafiltration

Timeline

• Start date: 2006-08-01
• Primary completion: 2012-10-01
• Completion: 2012-12-01
• First posted: 2006-08-07
• Last updated: 2016-01-28

Locations

1 site across 1 country: Italy