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

NCT03161158 | Terminated Results DMC

• 2 other identifiers: UF-HF-02-INTEUDAMED-No. CIV -17-01-018204
• Study Type: interventional
• Target: 62
• Locations: 2 countries
• Sites: 11

Brief 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

Heart Failure; Acute Heart Failure

Keywords

Cardio-Renal Syndrome type 1; Acutely decompensated chronic heart failure; Ultrafiltration

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Ultrafiltration Group

ACTIVE COMPARATOR

Veno-venous ultrafiltration (CHIARA-System) complementary to low-dose diuretic therapy according to treatment algorithm.

Device: CHIARA-System

Control group (Usual care IV diuretics)

OTHER

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

Other: Usual care IV diuretics

Interventions

CHIARA-System DEVICE

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.

Also known as: Low-dose IV diuretics

Ultrafiltration Group

Usual care IV diuretics OTHER

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

Control group (Usual care IV diuretics)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Symptoms of congestion and clinical evidence at the time of final screening for eligibility:
• Fluid overload manifested by at least 2 of the following:
• 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
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Fresenius Medical Care Deutschland GmbH: lead

Study Sites (11)

Universitätsklinikum Aachen (Med. Klinik II)

Aachen, 52074, Germany

Location

Helios Klinikum Duisburg

Duisburg, 47166, Germany

Location

Helios Klinikum Erfurt GmbH

Erfurt, 99089, Germany

Location

Medizinische Universitätsklinik, Innere Medizin III

Heidelberg, 69120, Germany

Location

Helios Klinikum Hildesheim GmbH

Hildesheim, 31135, Germany

Location

Klinikum Stuttgart, Klinik für Nieren-, Hochdruck- und Autoimmunerkrankungen

Stuttgart, 70174, Germany

Location

Falun Hospital

Falun, 79182, Sweden

Location

Universitetssjukhuset Örebro, Hjärtsviktsmottagningen

Örebro, SE-70185, Sweden

Location

Danderyds University Hospital

Stockholm, 182 88, Sweden

Location

Karolinska University Hospital Huddinge, Department of Cardiology

Stockholm, SE-14186, Sweden

Location

Uppsala University Hospital, Department of Cardiology

Uppsala, SE-75185, Sweden

Location

Related Publications (1)

• Srivastava M, Harrison N, Caetano AFS, Tan AR, Law M. Ultrafiltration for acute heart failure. Cochrane Database Syst Rev. 2022 Jan 21;1(1):CD013593. doi: 10.1002/14651858.CD013593.pub2.

  PMID: 35061249 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Limitations and Caveats

Due to the premature termination of the study and a resulting sample size of 37 patients in both analyses sets no statistical testing for any study endpoint has been applied. All study objectives were analyzed purely descriptively, continuous data with sample statistics, categorical data by frequency tables.

Results Point of Contact

• Title: Dr. Jennifer Braun
• Organization: Fresenius Medical Care Deutschland GmbH

Jennifer.Braun@fmc-ag.com

+49 6172 609 93488

Study Officials

• Frank Ruschitzka, Prof Dr med

  Universitätsspital Zürich, Klinik für Kardiologie

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multicenter, prospective, randomized, parallel-group, controlled

Study Record Dates

• First Submitted: May 2, 2017
• First Posted: May 19, 2017
• Study Start: November 3, 2017
• Primary Completion: August 26, 2019
• Study Completion: August 26, 2019
• Last Updated: May 5, 2021
• Results First Posted: May 5, 2021

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

SE (5); DE (6)