Treatment of Severe Heart Failure by Ultrafiltration

NCT ID: NCT00360958

Last Updated: 2016-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2012-12-31

Brief Summary

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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

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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.

Conditions

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Severe Congestive Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ultrafiltration

Ultrafiltration treatment

Group Type EXPERIMENTAL

ultrafiltration

Intervention Type PROCEDURE

Usual treatment

Usual HF treatment

Group Type ACTIVE_COMPARATOR

ultrafiltration

Intervention Type PROCEDURE

Interventions

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ultrafiltration

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centro Cardiologico Monzino

OTHER

Sponsor Role lead

Responsible Party

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Piergiuseppe Agostoni

MD PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Piergiuseppe Agostoni, MD.PhD

Role: PRINCIPAL_INVESTIGATOR

Centro Cardiologico Monzino

Locations

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Centro Cardiologico Monzino

Milan, , Italy

Site Status

Countries

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Italy

References

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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.

Reference Type DERIVED
PMID: 24269855 (View on PubMed)

Other Identifiers

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CCM S67/306

Identifier Type: -

Identifier Source: org_study_id

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