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Sponsored by: |
Centro Cardiologico Monzino |
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Information provided by: | Centro Cardiologico Monzino |
ClinicalTrials.gov Identifier: | NCT00360958 |
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.
Condition | Intervention | Phase |
---|---|---|
Severe Congestive Heart Failure |
Procedure: ultrafiltration |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Ultrafiltration for the Chronic Treatment of Severe Congestive Heart Failure |
Estimated Enrollment: | 60 |
Study Start Date: | August 2006 |
Estimated Study Completion Date: | August 2008 |
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.
Ages Eligible for Study: | 20 Years to 90 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Piergiuseppe Agostoni, MD-PhD | +39 02 58002299 | piergiuseppe.agostoni@ccfm.it |
Contact: Giancarlo Marenzi, MD | +39 02 58002582 | giancarlo.marenzi@ccfm.it |
Italy | |
Centro Cardiologico Monzino | Recruiting |
Milan, Italy, 20138 | |
Contact: Piergiuseppe Agostoni, MD,PhD +39 02 58002299 piergiuseppe.agostoni@ccfm.it | |
Principal Investigator: Piergiuseppe Agostoni, MD,PhD |
Principal Investigator: | Piergiuseppe Agostoni, MD.PhD | Centro Cardiologico Monzino |
Study ID Numbers: | CCM S67/306 |
Study First Received: | August 3, 2006 |
Last Updated: | August 7, 2006 |
ClinicalTrials.gov Identifier: | NCT00360958 |
Health Authority: | Italy: Ministry of Health |
ultrafiltration heart failure fluid overload |
Heart Failure Heart Diseases |
Cardiovascular Diseases |