Global rEgistry on decongestioN Therapy Using Less invasivE UltraFiltration

NCT02769351 | Terminated Results

• 2 other identifiers: UF-HF-01-INTDRKS00009836
• Study Type: observational
• Target: 104
• Locations: 3 countries
• Sites: 19

Brief Summary

In patients with advanced volume overload, minimally invasive ultrafiltration treatment in the acute phase can have a positive effect on clinical outcome. The aim is to collect treatment data in the context of a prospective registry of the safety and performance of minimally invasive ultrafiltration. The data will be recorded via an electronic case report form (eCRF); the eCRF runs on a server located in Germany and complies with current data protection regulations. It is intended to include about 300-500 patients with advanced volume overload at a minimum of 10 sites. In addition, data on a disease management programme (in-body measurement and home monitoring) will be recorded in up to 40 of these patients. The treatment data from each patient will be recorded over 12 months. An interim analysis will be performed after 150 patients have been observed for 6 months. The knowledge about ultrafiltration in volume overload obtained from the registry, in some cases in combination with a disease management programme, is intended to improve the body of evidence. In addition, the data will be used for hypothesis generation.

Conditions

Acute Heart Failure; Cardiac Decompensation; Volume Overload

Keywords

volume overload; heart failure; cardiac decompensation; ultrafiltration

Outcome Measures

Primary Outcomes (1)

• Rehospitalisation (Yes/no) Due to Exacerbation of Heart Failure/Volume Overload of Other Origin

  The number of rehospitalizations due to heart failure resp. volume overload has been measured as a clinical endpoint and analyzed based on the AP.

  12 months

Secondary Outcomes (4)

• Significant Deterioration of Kidney Function - Creatinine

  Recruitment; Discharge from Index Hospitalization; Outpatient visit I (3-9 months); Outpatient visit II ( 12 months)

• Significant Deterioration of Kidney Function - Urea

  Recruitment; Discharge from Index Hospitalization; Outpatient visit I (3-6 months); Outpatient visit II (12 months)

• Significant Deterioration of Kidney Function - eGFR (Estimated Glomerular Filtration Rate)

  Recruitment, Discharge from index hospitalization, Outapteint visit I (3-6 months), Outpatient visit II (12 months)

• Significant Deterioration of Kidney Function - Cystatin

  recruitment, discharge from the index hospitalization, Outpatient visit I (3-9 months), Outpatient visit II (12 months)

Study Arms (1)

periph. minimal invasive ultrafiltration

Patients with volume overload receiving ultrafiltration

Device: periph. minimal invasive ultrafiltration

Interventions

periph. minimal invasive ultrafiltration DEVICE

ultrafiltration via a peripheral single-needle

Also known as: ultrafiltration

periph. minimal invasive ultrafiltration

Eligibility Criteria

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

Study Population

Patients treated with minimally invasive ultrafiltration in support of diuretic drug therapy in the acute phase of volume overload.

You may qualify if:

• ≥18 years
• Inpatient-treated patients with acute volume overload, preferably in association with cardiac decompensation with signs of incipient diuretic resistance (lack of increase in urine output despite significant escalation of diuretic therapy; e.g. ≥80 mg furosemide / 24 h or less than 1375 mL urine output/40 mg furosemide per 24 h or equivalent dose of other loop diuretics \[established clinically or from the medical history\])
• Systolic or diastolic cardiac dysfunction (HF-REF or HF-PEF)
• Adequate venous access (preferably peripheral arm vein) allowing a flow rate ≥ 60 mL / min
• Written consent to the use of data in the registry (where necessary, by a legal guardian).

You may not qualify if:

• Contraindication to anticoagulation (e.g. known heparin-induced thrombocytopenia, severe bleeding)
• Terminal renal failure (stage V, GFR \<15 mL)
• Cardiogenic shock, e.g. in association with acute coronary syndrome (ACS)
• Other diseases or factors that, in the study doctor's opinion, constitute a potential contraindication to ultrafiltration
• Pregnant women, women in labour, breast-feeding women or women of childbearing potential, who are without adequate contraception or are planning a family. NB: a pregnancy test is performed systematically in women of childbearing age and the patient is not included in the event of pregnancy (positive test). It is absolutely essential that women, who have a negative test and who are included in the study, have an effective contraception.

Sponsors & Collaborators

• Fresenius Medical Care Deutschland GmbH: lead

Study Sites (19)

Universitätsklinikum Heidelberg

Heidelberg, Baden-Wurttemberg, 69120, Germany

Location

Helios Klinik für Herzchirurgie GmbH Karlsruhe

Karlsruhe, Baden-Wurttemberg, 76185, Germany

Location

Universitätsklinikum Mannheim

Mannheim, Baden-Wurttemberg, 68167, Germany

Location

Klinikum Stuttgart

Stuttgart, Baden-Wurttemberg, 70174, Germany

Location

Städtisches Klinikum Braunschweig

Braunschweig, Lower Saxony, 38126, Germany

Location

Helios Klinikum Hildesheim

Hildesheim, Lower Saxony, 31135, Germany

Location

Uniklinik RWTH Aachen

Aachen, North Rhine-Westphalia, 52074, Germany

Location

Helios Klinik Attendorn

Attendorn, North Rhine-Westphalia, 57439, Germany

Location

Helios Klinikum Duisburg

Duisburg, North Rhine-Westphalia, 47053, Germany

Location

HELIOS Klinikum Erfurt

Erfurt, Thuringia, 99089, Germany

Location

Helios Klinikum Berlin Buch

Berlin, 13125, Germany

Location

Falun Hospital

Falun, 79182, Sweden

Location

SUS Skanes University Hosptal

Malmo, 20502, Sweden

Location

University Hospital Örebro

Örebro, 70185, Sweden

Location

Karolinska University Hospital

Stockholm, 17176, Sweden

Location

Danderyd University Hospital

Stockholm, 18288, Sweden

Location

Uppsala University Hospital

Uppsala, 75185, Sweden

Location

Kantonsspital Aarau

Aarau, 5001, Switzerland

Location

UniversitätsSpital Zurich

Zurich, 8091, Switzerland

Location

Related Publications (2)

• Yancy CW, Jessup M, Bozkurt B, Butler J, Casey DE Jr, Drazner MH, Fonarow GC, Geraci SA, Horwich T, Januzzi JL, Johnson MR, Kasper EK, Levy WC, Masoudi FA, McBride PE, McMurray JJ, Mitchell JE, Peterson PN, Riegel B, Sam F, Stevenson LW, Tang WH, Tsai EJ, Wilkoff BL; American College of Cardiology Foundation; American Heart Association Task Force on Practice Guidelines. 2013 ACCF/AHA guideline for the management of heart failure: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2013 Oct 15;62(16):e147-239. doi: 10.1016/j.jacc.2013.05.019. Epub 2013 Jun 5. No abstract available.

  PMID: 23747642 BACKGROUND

• McMurray JJ, Adamopoulos S, Anker SD, Auricchio A, Bohm M, Dickstein K, Falk V, Filippatos G, Fonseca C, Gomez-Sanchez MA, Jaarsma T, Kober L, Lip GY, Maggioni AP, Parkhomenko A, Pieske BM, Popescu BA, Ronnevik PK, Rutten FH, Schwitter J, Seferovic P, Stepinska J, Trindade PT, Voors AA, Zannad F, Zeiher A; Task Force for the Diagnosis and Treatment of Acute and Chronic Heart Failure 2012 of the European Society of Cardiology; Bax JJ, Baumgartner H, Ceconi C, Dean V, Deaton C, Fagard R, Funck-Brentano C, Hasdai D, Hoes A, Kirchhof P, Knuuti J, Kolh P, McDonagh T, Moulin C, Popescu BA, Reiner Z, Sechtem U, Sirnes PA, Tendera M, Torbicki A, Vahanian A, Windecker S, McDonagh T, Sechtem U, Bonet LA, Avraamides P, Ben Lamin HA, Brignole M, Coca A, Cowburn P, Dargie H, Elliott P, Flachskampf FA, Guida GF, Hardman S, Iung B, Merkely B, Mueller C, Nanas JN, Nielsen OW, Orn S, Parissis JT, Ponikowski P; ESC Committee for Practice Guidelines. ESC guidelines for the diagnosis and treatment of acute and chronic heart failure 2012: The Task Force for the Diagnosis and Treatment of Acute and Chronic Heart Failure 2012 of the European Society of Cardiology. Developed in collaboration with the Heart Failure Association (HFA) of the ESC. Eur J Heart Fail. 2012 Aug;14(8):803-69. doi: 10.1093/eurjhf/hfs105. No abstract available.

  PMID: 22828712 BACKGROUND

MeSH Terms

Conditions

Heart Failure; Edema

Interventions

Ultrafiltration

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Extracorporeal Circulation; Surgical Procedures, Operative; Filtration; Chemistry Techniques, Analytical; Investigative Techniques; Physical Phenomena; Chemical Phenomena

Results Point of Contact

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

jennifer.braun@fmc-ag.com

+49617260893488

Study Officials

• Henning T Baberg, MD

  Helios Klinikum Berlin Buch, Berlin

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2016
• First Posted: May 11, 2016
• Study Start: December 3, 2015
• Primary Completion: March 4, 2019
• Study Completion: March 4, 2019
• Last Updated: August 5, 2021
• Results First Posted: July 8, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (11); CH (2); SE (6)