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

April 8, 2021 updated by: Fresenius Medical Care Deutschland GmbH
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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
62

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Aachen, Germany, 52074
        • Universitätsklinikum Aachen (Med. Klinik II)
      • Duisburg, Germany, 47166
        • Helios Klinikum Duisburg
      • Erfurt, Germany, 99089
        • Helios Klinikum Erfurt GmbH
      • Heidelberg, Germany, 69120
        • Medizinische Universitätsklinik, Innere Medizin III
      • Hildesheim, Germany, 31135
        • Helios Klinikum Hildesheim GmbH
      • Stuttgart, Germany, 70174
        • Klinikum Stuttgart, Klinik für Nieren-, Hochdruck- und Autoimmunerkrankungen
  • Sweden
      • Falun, Sweden, 79182
        • Falun Hospital
      • Stockholm, Sweden, 182 88
        • Danderyds University Hospital
      • Stockholm, Sweden, SE-14186
        • Karolinska University Hospital Huddinge, Department of Cardiology
      • Uppsala, Sweden, SE-75185
        • Uppsala University Hospital, Department of Cardiology
      • Örebro, Sweden, SE-70185
        • Universitetssjukhuset Örebro, Hjärtsviktsmottagningen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Ultrafiltration Group
Veno-venous ultrafiltration (CHIARA-System) complementary to low-dose diuretic therapy according to treatment algorithm.
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 Names:
  • Low-dose IV diuretics
Other: Control group (Usual care IV diuretics)
Guideline-directed therapy including IV loop diuretics according to treatment algorithm.
Other: Usual care IV diuretics
Guideline-directed therapy including IV loop diuretics (according to treatment algorithm)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Heart Failure (HF) Event
Time Frame: in 90 days after discharge
Heart failure hospitalization or unscheduled outpatient or emergency department treatment with IV loop diuretics or ultrafiltration.
in 90 days after discharge
Cardiovascular Death up to 90 Days After Randomization.
Time Frame: in 90 days after discharge
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fresenius Medical Care Deutschland GmbH

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Frank Ruschitzka, Prof Dr med, Universitätsspital Zürich, Klinik für Kardiologie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 3, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 26, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 26, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 2, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 18, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 19, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 5, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UF-HF-02-INT
  • EUDAMED-No. CIV -17-01-018204 (Other Identifier: European Medicines Agency)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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