Treatment of Severe Heart Failure by Ultrafiltration | NCT00360958

Studies
Treatment of Severe Heart Failure by Ultrafiltration

NCT00360958

Sponsor

Centro Cardiologico Monzino

Status

Completed

Last Update Posted

Jan 28, 2016Estimated

Enrollment

60Actual

Phase

Phase 4

Conditions

Severe Congestive Heart Failure

Interventions

ultrafiltration

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2006

Primary Completion Date

Oct 2012Actual

Completion Date

Dec 2012Actual

First Submitted Date

Aug 3, 2006

First Submission Date that Met QC Criteria

Aug 3, 2006

First Posted Date

Aug 7, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 27, 2016

Last Update Posted Date

Jan 28, 2016Estimated

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ultrafiltration	Experimental	Ultrafiltration treatment	Procedure: ultrafiltration
Usual treatment	Active Comparator	Usual HF treatment	Procedure: ultrafiltration

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ultrafiltration	Procedure		Ultrafiltration Usual treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
number of hospitalizations for heart failure		End of study

Secondary Outcomes

Measure	Description	Time Frame
long term major adverse clinical events including death		End of study

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Piergiuseppe Agostoni, MD.PhD	Centro Cardiologico Monzino	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centro Cardiologico Monzino		Milan		20138	Italy

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24269855	Derived	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.

ID	Term
D006333	Heart Failure
D004487	Edema

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D005112	Extracorporeal Circulation
D013514	Surgical Procedures, Operative
D005374	Filtration
D002623	Chemistry Techniques, Analytical