Back to resultsTreatment of Severe Heart Failure by Ultrafiltration
Primary Purpose
Severe Congestive Heart Failure
Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
ultrafiltration
Sponsored by
About this trial
This is an interventional treatment trial for Severe Congestive Heart Failure focused on measuring ultrafiltration, heart failure, fluid overload
Eligibility 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
Sites / Locations
- Centro Cardiologico Monzino
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Ultrafiltration
Usual treatment
Arm Description
Ultrafiltration treatment
Usual HF treatment
Outcomes
Primary Outcome Measures
number of hospitalizations for heart failure
Secondary Outcome Measures
long term major adverse clinical events including death
Full Information
NCT ID
NCT00360958
First Posted
August 3, 2006
Last Updated
January 27, 2016
Sponsor
Centro Cardiologico Monzino
1. Study Identification
Unique Protocol Identification Number
NCT00360958
Brief Title
Treatment of Severe Heart Failure by Ultrafiltration
Official Title
Ultrafiltration for the Chronic Treatment of Severe Congestive Heart Failure
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centro Cardiologico Monzino
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Congestive Heart Failure
Keywords
ultrafiltration, heart failure, fluid overload
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ultrafiltration
Arm Type
Experimental
Arm Description
Ultrafiltration treatment
Arm Title
Usual treatment
Arm Type
Active Comparator
Arm Description
Usual HF treatment
Intervention Type
Procedure
Intervention Name(s)
ultrafiltration
Primary Outcome Measure Information:
Title
number of hospitalizations for heart failure
Time Frame
End of study
Secondary Outcome Measure Information:
Title
long term major adverse clinical events including death
Time Frame
End of study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Piergiuseppe Agostoni, MD.PhD
Organizational Affiliation
Centro Cardiologico Monzino
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro Cardiologico Monzino
City
Milan
ZIP/Postal Code
20138
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
24269855
Citation
Marenzi G, Muratori M, Cosentino ER, Rinaldi ER, Donghi V, Milazzo V, Ferramosca E, Borghi C, Santoro A, Agostoni P. Continuous ultrafiltration for congestive heart failure: the CUORE trial. J Card Fail. 2014 Jan;20(1):9-17. doi: 10.1016/j.cardfail.2013.11.004. Epub 2013 Nov 20. Erratum In: J Card Fail. 2014 May;20(5):378.
Results Reference
derived
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Treatment of Severe Heart Failure by Ultrafiltration
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