TerminatedNot Applicable

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

Stopped: Low recruitment

Germany62 participantsStarted 2017-11-03

Plain-language 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).

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Pitting edema ≥2+ of the lower extremities
✓. Jugular venous pressure \>8 cm H2O
✓. Pulmonary congestion or pleural effusion on chest x-ray
✓. Paroxysmal nocturnal dyspnea or ≥2- pillow orthopnea
✓. Respiration rate ≥20 per minute

What they're measuring

Heart Failure (HF) Event

Timeframe: in 90 days after discharge

Cardiovascular Death up to 90 Days After Randomization.

Timeframe: in 90 days after discharge

Trial details

NCT IDNCT03161158

SponsorFresenius Medical Care Deutschland GmbH

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-08-26

Results submitted2020-12-16

View on ClinicalTrials.gov More Heart Failure trials