Acute Heart Failure Clinical Trial
— GENTLE-UFOfficial title:
A Multicentre, Prospective Registry to Evaluate the Safety and Efficacy of Minimally Invasive Ultrafiltration Treatment and Its Effect on Symptoms and Rehospitalisation in Patients With Advanced Volume Overload
Verified date | April 2021 |
Source | Fresenius Medical Care Deutschland GmbH |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
Status | Terminated |
Enrollment | 104 |
Est. completion date | March 4, 2019 |
Est. primary completion date | March 4, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - =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]) - New York Association Functional Class (NYHA) III-IV at inclusion - 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). Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Germany | Uniklinik RWTH Aachen | Aachen | North Rhine-Westphalia |
Germany | Helios Klinik Attendorn | Attendorn | Nordrhein-Westfalen |
Germany | Helios Klinikum Berlin Buch | Berlin | |
Germany | Städtisches Klinikum Braunschweig | Braunschweig | Niedersachsen |
Germany | Helios Klinikum Duisburg | Duisburg | North Rhine-Westphalia |
Germany | HELIOS Klinikum Erfurt | Erfurt | Thueringen |
Germany | Universitätsklinikum Heidelberg | Heidelberg | Baden Württemberg |
Germany | Helios Klinikum Hildesheim | Hildesheim | Niedersachsen |
Germany | Helios Klinik für Herzchirurgie GmbH Karlsruhe | Karlsruhe | Baden- Württemberg |
Germany | Universitätsklinikum Mannheim | Mannheim | Baden-Württemberg |
Germany | Klinikum Stuttgart | Stuttgart | Baden Württemberg |
Sweden | Falun Hospital | Falun | |
Sweden | SUS Skanes University Hosptal | Malmö | |
Sweden | University Hospital Örebro | Örebro | |
Sweden | Danderyd University Hospital | Stockholm | |
Sweden | Karolinska University Hospital | Stockholm | |
Sweden | Uppsala University Hospital | Uppsala | |
Switzerland | Kantonsspital Aarau | Aarau | |
Switzerland | UniversitätsSpital Zurich | Zurich |
Lead Sponsor | Collaborator |
---|---|
Fresenius Medical Care Deutschland GmbH |
Germany, Sweden, Switzerland,
McMurray JJ, Adamopoulos S, Anker SD, Auricchio A, Böhm M, Dickstein K, Falk V, Filippatos G, Fonseca C, Gomez-Sanchez MA, Jaarsma T, Køber L, Lip GY, Maggioni AP, Parkhomenko A, Pieske BM, Popescu BA, Rønnevik 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. Erratum in: Eur J Heart Fail. 2013 Mar;15(3):361-2. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Significant Deterioration of Kidney Function - Creatinine | Significant deterioration of kidney function has been measured as a safety endpoint and analyzed based on the SP. The variables have been measured at recruitment, discharge from the index hospitalization, Outpatient visit I (3-9 months) and Outpatient visit II (12 months). | Recruitment; Discharge from Index Hospitalization; Outpatient visit I (3-9 months); Outpatient visit II ( 12 months) | |
Secondary | Significant Deterioration of Kidney Function - Urea | Significant deterioration of kidney function has been measured as a safety endpoint and analyzed based on the SP. The variables have been measured at recruitment, discharge from the index hospitalization, Outpatient visit I (3-9 months) and Outpatient visit II (12 months). | Recruitment; Discharge from Index Hospitalization; Outpatient visit I (3-6 months); Outpatient visit II (12 months) | |
Secondary | Significant Deterioration of Kidney Function - eGFR (Estimated Glomerular Filtration Rate) | Significant deterioration of kidney function has been measured as a safety endpoint and analyzed based on the SP. The variables have been measured at recruitment, discharge from the index hospitalization, Outpatient visit I (3-9 months) and Outpatient visit II (12 months). | Recruitment, Discharge from index hospitalization, Outapteint visit I (3-6 months), Outpatient visit II (12 months) | |
Secondary | Significant Deterioration of Kidney Function - Cystatin | Significant deterioration of kidney function has been measured as a safety endpoint and analyzed based on the SP. The variables have been measured at recruitment, discharge from the index hospitalization, Outpatient visit I (3-9 months) and Outpatient visit II (12 months). | recruitment, discharge from the index hospitalization, Outpatient visit I (3-9 months), Outpatient visit II (12 months) |
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