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Treatment of Severe Heart Failure by Ultrafiltration

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2006 by Centro Cardiologico Monzino.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Centro Cardiologico Monzino
ClinicalTrials.gov Identifier:
NCT00360958
First received: August 3, 2006
Last updated: August 7, 2006
Last verified: July 2006
History of Changes
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Ultrafiltration for the Chronic Treatment of Severe Congestive Heart Failure

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

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

No publications provided

ClinicalTrials.gov Identifier: NCT00360958     History of Changes
Other Study ID Numbers: CCM S67/306
Study First Received: August 3, 2006
Last Updated: August 7, 2006
Health Authority: Italy: Ministry of Health

Keywords provided by Centro Cardiologico Monzino:
ultrafiltration
heart failure
fluid overload

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 22, 2013