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Completed

NCT Number: NCT00360958

Treatment of Severe Heart Failure by Ultrafiltration

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.

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Key information

Conditions

Severe Congestive Heart Failure Cardiovascular Diseases Edema Heart Diseases Heart Failure Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Centro Cardiologico Monzino

Milan, 20138, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrafiltration

Procedure

Primary outcomes

  1. number of hospitalizations for heart failure

    Time frame: End of study

Secondary outcomes

  1. long term major adverse clinical events including death

    Time frame: End of study

Sponsors and collaborators

Lead sponsor

Centro Cardiologico Monzino

Other

Registry information

Official study title

Ultrafiltration for the Chronic Treatment of Severe Congestive Heart Failure

Important dates

Study start
2006
Primary completion
2012
Study completion
2012
First posted
Aug 7, 2006
Registry last updated
Jan 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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