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Treatment of Severe Heart Failure by Ultrafiltration

C

Centro Cardiologico Monzino

Status and phase

Completed
Phase 4

Conditions

Severe Congestive Heart Failure

Treatments

Procedure: ultrafiltration

Study type

Interventional

Funder types

Other

Identifiers

NCT00360958
CCM S67/306

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 patients

Sex

All

Ages

20 to 90 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 2 patient groups

Ultrafiltration
Experimental group
Description:
Ultrafiltration treatment
Treatment:
Procedure: ultrafiltration
Usual treatment
Active Comparator group
Description:
Usual HF treatment
Treatment:
Procedure: ultrafiltration

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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