Treatment of Severe Heart Failure by Ultrafiltration - Full Text View

Sponsored by:	Centro Cardiologico Monzino
Information provided by:	Centro Cardiologico Monzino
ClinicalTrials.gov Identifier:	NCT00360958

Purpose

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

MedlinePlus related topics: Heart Failure

U.S. FDA Resources

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

Further study details as provided by Centro Cardiologico Monzino:

Primary Outcome Measures:

number of hospitalizations for heart failure

Secondary Outcome Measures:

long term major adverse clinical events including death

Estimated Enrollment:	60
Study Start Date:	August 2006
Estimated Study Completion Date:	August 2008

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.

Eligibility

Ages Eligible for Study:	20 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00360958

Contacts

Contact: Piergiuseppe Agostoni, MD-PhD	+39 02 58002299	piergiuseppe.agostoni@ccfm.it
Contact: Giancarlo Marenzi, MD	+39 02 58002582	giancarlo.marenzi@ccfm.it

Locations

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

Sponsors and Collaborators

Centro Cardiologico Monzino

Investigators

Principal Investigator:

Piergiuseppe Agostoni, MD.PhD

Centro Cardiologico Monzino

More Information

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

Keywords provided by Centro Cardiologico Monzino:

ultrafiltration
heart failure
fluid overload

Study placed in the following topic categories:

Heart Failure
Heart Diseases

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 15, 2009