Treatment of Severe Heart Failure by Ultrafiltration

Phase 4

Completed

• Conditions: Severe Congestive Heart Failure
• Interventions: Procedure: ultrafiltration

• Registration Number: NCT00360958
• Lead Sponsor: Centro Cardiologico Monzino

Brief 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.

Study Timeline

• Study Start: 2006-08
• Study First Submitted: 2006-08-03
• Study First Submitted QC: 2006-08-03
• Study First Posted: 2006-08-07
• Primary Completion: 2012-10
• Study Completion: 2012-12
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-27
• Last Update Posted: 2016-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Severe heart failure (NYHA III-IV) with fluid overload
• Ejection fraction < 40%
• Estimated fluid overload > 4 kg

Exclusion Criteria

• Severe renal insufficiency
• Acute pulmonary edema and/or cardiogenic shock

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ultrafiltration	ultrafiltration	Ultrafiltration treatment
Usual treatment	ultrafiltration	Usual HF treatment

Primary Outcome Measures

Name	Time	Method
number of hospitalizations for heart failure	End of study

Secondary Outcome Measures

Name	Time	Method
long term major adverse clinical events including death	End of study

Trial Locations

Locations (1)

Centro Cardiologico Monzino; 🇮🇹 Milan, Italy