Trials / Terminated
TerminatedNCT03161158
PURE-HF: Peripheral Ultrafiltration for the RElief From Congestion in Heart Failure
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 62 (actual)
- Sponsor
- Fresenius Medical Care Deutschland GmbH · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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).
Detailed description
The study will evaluate whether stepped, peripheral ultrafiltration complementary to low-dose diuretics influences 90-day clinical outcomes compared to usual care including intravenous diuretics in symptomatic heart failure patients with persistent congestion. Hospitalized subjects will be randomly assigned to receive either a tailored, peripheral ultrafiltration approach complementary to intravenous low-dose diuretics and other guideline-directed medical therapy OR high-dose diuretic therapy and other Guideline-directed medical therapy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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) |
Timeline
- Start date
- 2017-11-03
- Primary completion
- 2019-08-26
- Completion
- 2019-08-26
- First posted
- 2017-05-19
- Last updated
- 2021-05-05
- Results posted
- 2021-05-05
Locations
11 sites across 2 countries: Germany, Sweden
Source: ClinicalTrials.gov record NCT03161158. Inclusion in this directory is not an endorsement.