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PURE-HF: Peripheral Ultrafiltration for the RElief From Congestion in Heart Failure

NCT03161158 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2021-05-05

Study results available
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Summary

This study evaluates whether tailored, peripheral ultrafiltration complementary to low-dose diuretics is associated with a reduction in cardiovascular mortality in 90 days after randomization and heart failure events in 90 days after discharge than usual care including stepped intravenous diuretics in acutely decompensated chronic heart failure with fluid overload (not fully responsive to diuretic therapy).

Conditions

Interventions

DEVICE

CHIARA-System

Treatment with veno-venous ultrafiltration (CHIARA-System) complementary to low-dose diuretic therapy according to treatment algorithm. 1-7 Ultrafiltration sessions (6-10h/session, number of sessions depending on clinical assessment) for at least 1-2 consecutive days and a maximum of 7 days.

OTHER

Usual care IV diuretics

Guideline-directed therapy including IV loop diuretics (according to treatment algorithm)

Sponsors & Collaborators

  • Fresenius Medical Care Deutschland GmbH

    lead INDUSTRY

Principal Investigators

  • Frank Ruschitzka, Prof Dr med · Universitätsspital Zürich, Klinik für Kardiologie

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-03
Primary Completion
2019-08-26
Completion
2019-08-26

Countries

  • Germany
  • Sweden

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03161158 on ClinicalTrials.gov