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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03161158
• Other study ID #: UF-HF-02-INT
• Secondary ID: EUDAMED-No. CIV
• Status: Terminated
• Phase: N/A
• Start date: November 3, 2017
• Est. completion date: August 26, 2019

Study information

• Verified date: July 2020
• Source: Fresenius Medical Care Deutschland GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 62
• Est. completion date: August 26, 2019
• Est. primary completion date: August 26, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

General:

Informed consent signed and dated by study patient and investigator/authorised physician

• Minimum age of 18 years

• Ability to understand the nature and requirements of the study

Study-specific:

• Heart failure patients with preserved, mid-range or reduced ejection fraction (confirmed according to the current definitions of heart failure with preserved (HFpEF), mid-range (HFmrEF) and reduced ejection fraction (HFrEF) requiring echocardiographic assessment within the prior 12 months) who are admitted to the hospital due to signs/symptoms of congestion (left- or right sided)

• On regularly scheduled oral loop diuretics prior to admission

• Patients who have received IV loop diuretics for decongestion within 24 hours after hospital admission and prior to screening. The dosages are administered according to clinical judgment.** (**This inclusion criterion was changed with CIP amendment; in former version 3.0 it read "After pre-screening and prior to final screening for eligibility, patients who have received two boluses of IV loop diuretics (Dose according to the Furosemide-Low Intensification, Q12 hour bolus arm of the DOSE trial))

• Symptoms of congestion and clinical evidence at the time of final screening for eligibility:

• Fluid overload manifested by at least 2 of the following:

1. Pitting edema =2+ of the lower extremities

2. Jugular venous pressure >8 cm H2O

3. Pulmonary congestion or pleural effusion on chest x-ray

4. Paroxysmal nocturnal dyspnea or =2- pillow orthopnea

5. Respiration rate =20 per minute

• Additional objective documentation of congestion: Lung or inferior vena cava ultrasound, chest x-ray or elevated filling pressures, if available, at the time of randomization (optional)

Exclusion Criteria:

General:

• Any condition which could interfere with the patient's ability to comply with the study

• In case of female patients, pregnancy or lactation period

• Participation in an interventional clinical study during the preceding 30 days

• Previous participation in the same study

• Unwillingness or inability to complete follow up

• Active drug or alcohol abuse (smoking allowed)

Study-specific:

• Acute coronary syndrome requiring intervention during index hospitalization

• Severe renal dysfunction requiring renal replacement therapy

• Systolic blood pressure < 90 mmHg at the time of randomization

• Pulmonary hypertension not secondary to left heart disease

• Pulmonary disease thought to be primarily responsible for symptoms

• Contraindication to systemic anticoagulation

• Severe concomitant disease expected to prolong hospitalization or to cause death in = 90 days

• Sepsis

• Severe uncorrected valvular stenosis at the time of randomization

• Active myocarditis

• Hypertrophic obstructive cardiomyopathy

• Constrictive pericarditis or restrictive cardiomyopathy

• Liver cirrhosis due to primary liver disease* (*Restriction "due to primary liver disease" was present after amendment in study protocol version 5.0 but not in version 3.0)

• Known infection with human immunodeficiency virus (HIV) or active hepatitis C

• Previous solid organ transplant

• Presence or requirement for mechanical respiratory support

• Presence or requirement of a mechanical circulatory support device

• Need for IV positive inotropic agents at the time of randomization

Related Conditions & MeSH terms

• Acute Heart Failure
• Heart Failure

Intervention

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)

Locations

Country	Name	City	State
Germany	Universitätsklinikum Aachen (Med. Klinik II)	Aachen
Germany	Helios Klinikum Duisburg	Duisburg
Germany	Helios Klinikum Erfurt GmbH	Erfurt
Germany	Medizinische Universitätsklinik, Innere Medizin III	Heidelberg
Germany	Helios Klinikum Hildesheim GmbH	Hildesheim
Germany	Klinikum Stuttgart, Klinik für Nieren-, Hochdruck- und Autoimmunerkrankungen	Stuttgart
Sweden	Falun Hospital	Falun
Sweden	Universitetssjukhuset Örebro, Hjärtsviktsmottagningen	Örebro
Sweden	Danderyds University Hospital	Stockholm
Sweden	Karolinska University Hospital Huddinge, Department of Cardiology	Stockholm
Sweden	Uppsala University Hospital, Department of Cardiology	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
Fresenius Medical Care Deutschland GmbH

Countries where clinical trial is conducted

Germany,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart Failure (HF) Event	Heart failure hospitalization or unscheduled outpatient or emergency department treatment with IV loop diuretics or ultrafiltration.	in 90 days after discharge
Primary	Cardiovascular Death up to 90 Days After Randomization.	The rationale for the follow up time period of 90 days is that death rates reported in previous acute HF trials indicate that mortality seems to become linear after ~60-90 days post discharge Collection for Cardiovascular Trials initiative definition of cardiovascular death includes death resulting from an acute myocardial infarction, sudden cardiac death, death due to heart failure, death due to stroke, and death due to other cardiovascular causes	in 90 days after discharge