Severe Congestive Heart Failure
Conditions
Keywords
ultrafiltration, heart failure, fluid overload
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.
Interventions
PROCEDUREultrafiltration
Sponsors
Centro Cardiologico Monzino
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| number of hospitalizations for heart failure | End of study |
Secondary
| Measure | Time frame |
|---|---|
| long term major adverse clinical events including death | End of study |
Countries
Italy
Outcome results
None listed