NCT00360958

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Aug 2006

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

August 3, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 7, 2006

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

January 28, 2016

Status Verified

January 1, 2016

Enrollment Period

6.2 years

First QC Date

August 3, 2006

Last Update Submit

January 27, 2016

Conditions

Severe Congestive Heart Failure

Keywords

ultrafiltrationheart failurefluid overload

Outcome Measures

Primary Outcomes (1)

  • number of hospitalizations for heart failure

    End of study

Secondary Outcomes (1)

  • long term major adverse clinical events including death

    End of study

Study Arms (2)

Ultrafiltration

EXPERIMENTAL

Ultrafiltration treatment

Procedure: ultrafiltration

Usual treatment

ACTIVE COMPARATOR

Usual HF treatment

Procedure: ultrafiltration

Interventions

ultrafiltrationPROCEDURE
UltrafiltrationUsual treatment

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Severe heart failure (NYHA III-IV) with fluid overload
  • Ejection fraction \< 40%
  • Estimated fluid overload \> 4 kg

You may not qualify if:

  • Severe renal insufficiency
  • Acute pulmonary edema and/or cardiogenic shock

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro Cardiologico Monzino

Milan, 20138, Italy

Location

Related Publications (1)

  • 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.

    PMID: 24269855DERIVED

MeSH Terms

Conditions

Heart FailureEdema

Interventions

Ultrafiltration

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Extracorporeal CirculationSurgical Procedures, OperativeFiltrationChemistry Techniques, AnalyticalInvestigative TechniquesPhysical PhenomenaChemical Phenomena

Study Officials

  • Piergiuseppe Agostoni, MD.PhD

    Centro Cardiologico Monzino

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

August 3, 2006

First Posted

August 7, 2006

Study Start

August 1, 2006

Primary Completion

October 1, 2012

Study Completion

December 1, 2012

Last Updated

January 28, 2016

Record last verified: 2016-01

Locations

IT(1)