A Trial to Study BAY1753011 in Patients With Congestive Heart Failure
NCT ID: NCT03901729
Last Updated: 2022-04-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
482 participants
INTERVENTIONAL
2019-05-29
2021-05-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Arm 1
BAY1753011 30mg in addition to standard of care (SoC) for part A and part B
BAY 1753011
Tablet; 30mg or 5mg unit; 30mg once daily in the morning; Oral
Arm 2
Placebo of BAY1753011 in addition to SoC for part A and part B
Placebo BAY 1753011
Tablet; Once daily in the morning; Oral
Arm 1-A
BAY1753011 30mg in addition to Placebo Furosemide 80mg for part B
BAY 1753011
Tablet; 30mg or 5mg unit; 30mg once daily in the morning; Oral
Placebo Furosemide
Tablet; Once daily in the morning; Oral
Arm 1-B
Furosemide 80mg in addition to Placebo BAY1753011 30mg for part B
Placebo BAY 1753011
Tablet; Once daily in the morning; Oral
Furosemide
Tablet; 40mg unit; 80mg once daily in the morning; Oral
Arm 2-A
BAY1753011 30mg in addition to Placebo Furosemide 80mg for part B
BAY 1753011
Tablet; 30mg or 5mg unit; 30mg once daily in the morning; Oral
Placebo Furosemide
Tablet; Once daily in the morning; Oral
Arm 2-B
Furosemide 80mg in addition to Placebo BAY1753011 30mg for part B
Placebo BAY 1753011
Tablet; Once daily in the morning; Oral
Furosemide
Tablet; 40mg unit; 80mg once daily in the morning; Oral
Interventions
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BAY 1753011
Tablet; 30mg or 5mg unit; 30mg once daily in the morning; Oral
Placebo BAY 1753011
Tablet; Once daily in the morning; Oral
Furosemide
Tablet; 40mg unit; 80mg once daily in the morning; Oral
Placebo Furosemide
Tablet; Once daily in the morning; Oral
Eligibility Criteria
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Inclusion Criteria
* Subjects admitted to the hospital with a primary diagnosis of decompensated HF including symptoms and signs of fluid overload requiring IV diuretic therapy in the Emergency room (ER) or any time between day 1-3 of hospital admission (index hospitalization).
* Subjects on an average/usual total daily dose of loop diuretic ≥ 40 mg of furosemide or equivalent, within 4 weeks prior to index hospitalization.
* At least one of the following 5 parameters any day between 3-7 of index hospitalization (screening period)
* Natriuretic peptides Brain natriuretic peptide/N-terminal prohormone of brain natriuretic peptide (BNP/NT-proBNP):
* Drop in BNP or NT-proBNP ≤ 30% from admission values (if measured during index hospitalization) or
* BNP ≥ 500 pg/ml or NT-proBNP ≥ 1800 pg/ml at screening (day 3 to 7 of index hospitalization)
* Body weight (BW) loss \<0.4 kg per 40 mg furosemide at day 4 of index hospitalization
* Composite congestion score (CCS) ≥ 3
* Hypervolemic hyponatremia defined as serum sodium \< 136 mmol/l
* In hospital worsening renal function defined as increased serum creatinine ≥ 0.3 mg/dl compared to index hospitalization admission values AND at least one the following
* Jugular venous pressure (JVP) ≥ 10 cm on physical examination
* Inferior vena cava (IVC) diameter \> 21 mm
* IVC collapse with sniff \< 50%
* At least 2+ peripheral edema or pulmonary edema or pleural effusion on chest X-ray or clinical exam
Exclusion Criteria
* Acute coronary syndrome, including unstable angina, Non-ST segment elevation myocardial infarction (NSTEMI) or ST segment elevation myocardial infarction (STEMI), or major Cardiovascular (CV) surgery including coronary artery bypass graft (CABG), percutaneous coronary intervention (PCI) within 3 months prior to screening
* Any primary cause of HF scheduled for surgery or interventional therapy (e.g., TAVI), e.g., valve disease such as severe aortic stenosis or mitral valve regurgitation
* Requirement of mechanical support (intra-aortic balloon pump, endotracheal intubation, mechanical ventilation, or any ventricular assist device) or ultrafiltration/hemodialysis
* Estimated glomerular filtration rate of \< 30 ml/min/1.73 m\*2 determined by the Modified Diet and Renal Disease equation at screening; reassessments allowed as clinically needed
* Serum potassium ≥ 5.5 mmol/L or ≤ 3.3 mmol/L at screening; reassessments allowed as clinically needed
* Serum sodium ≥ 146 mmol/L or ≤ 130 mmol/L at screening; reassessments allowed as clinically needed
* Concomitant treatment with potassium-sparing diuretic (with the exception of mineralocorticoid- receptor antagonist (MRA) that cannot be stopped prior to randomization and for the duration of the treatment period.
18 Years
85 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Locations
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Universitätsklinikum St. Pölten
Sankt Pölten, Lower Austria, Austria
Medizinische Universität Graz
Graz, Styria, Austria
Krankenhaus St. Josef Braunau
Braunau am Inn, Upper Austria, Austria
Universitätsklinikum AKH Wien
Vienna, , Austria
Klinik Floridsdorf - Krankenhaus Nord
Vienna, , Austria
MHAT Haskovo
Haskovo, , Bulgaria
Spec Hosp for Active Treatm in Cardiology Sv Georgi Pernik
Pernik, , Bulgaria
UMHAT Dr. Georgi Stranski
Pleven, , Bulgaria
Multiprofile Hospital for Active Treatment Medline Clinic
Plovdiv, , Bulgaria
MHAT "Knyaginya Klementina - Sofia"EAD
Sofia, , Bulgaria
NMTH Tzar Boris III
Sofia, , Bulgaria
UMHAT Tsaritsa Joanna-ISUL EAD Sofia
Sofia, , Bulgaria
KAT General Hospital of Athens
Kifisia / Athens, Attica, Greece
G. GENNIMATAS General State Hospital of Athens
Athens, , Greece
University General Hospital of Athens "ATTIKON"
Chaidari - Athens, , Greece
University General Hospital of Ioannina
Ioannina, , Greece
Univ. General Hospital of Larissa
Larissa, , Greece
Konstantopoulio General Hospital of Nea Ionia - AGIA OLGA
Nea Ionia / Athens, , Greece
"AHEPA" University General Hospital of Thessaloniki
Thessaloniki, , Greece
Hippokration General Hospital of Thessaloniki
Thessaloniki, , Greece
Budai Irgalmasrendi Korhaz
Budapest, , Hungary
University of Semmelweis/ Semmelweis Egyetem
Budapest, , Hungary
Magyar Honvedseg Egeszsegugyi Kozpont Honvedkorhaz
Budapest, , Hungary
Kanizsai Dorottya Hospital
Nagykanizsa, , Hungary
Josa Andras Hospital
Nyíregyháza, , Hungary
Tolna Megyei Balassa Janos Korhaz
Szekszárd, , Hungary
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
Székesfehérvár, , Hungary
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz
Szolnok, , Hungary
Zala Megyei Szent Rafael Korhaz
Zalaegerszeg, , Hungary
Barzilai Medical Center
Ashkelon, , Israel
Rambam Health Corporation
Haifa, , Israel
Hadassah Hebrew University Hospital Ein Kerem
Jerusalem, , Israel
Health Corporation of Galilee Medical Center
Nahariya, , Israel
Chaim Sheba Medical Center
Ramat Gan, , Israel
Tel-Aviv Sourasky Medical Center
Tel Aviv, , Israel
Shamir Medical Center (Assaf Harofeh)
Zrifin, , Israel
A.O.U. di Ferrara
Ferrara, Emilia-Romagna, Italy
AUSL della Romagna
Rimini, Emilia-Romagna, Italy
ASST Papa Giovanni XXIII
Bergamo, Lombardy, Italy
ASST Spedali Civili di Brescia
Brescia, Lombardy, Italy
IRCCS Centro Cardiologico Monzino S.p.A
Milan, Lombardy, Italy
Fondazione Policlinico di Monza
Monza Brianza, Lombardy, Italy
AUSL Toscana Sud-Est
Arezzo, Tuscany, Italy
Fondazione Toscana Gabriele Monasterio (FTGM)
Pisa, Tuscany, Italy
A.O.U. Senese
Siena, Tuscany, Italy
Uniwersytecki Szpital Kliniczny w Bialymstoku
Bialystok, , Poland
10 Wojskowy Szpital Kliniczny z Poliklinika SPZOZ
Bydgoszcz, , Poland
Szpital sw. Wincentego a Paulo
Gdynia, , Poland
Samodzielny Publiczny Specjalistyczny Szpital Zachodni
Grodzisk Mazowiecki, , Poland
Szpital Kliniczny Przemienienia Panskiego
Poznan, , Poland
Szpital Wojewodzki Nr 2
Rzeszów, , Poland
Uniwersyteckie Centrum Kliniczne Warszawskiego UM
Warsaw, , Poland
Uniwersytecki Szpital Kliniczny UM we Wroclawiu
Wroclaw, , Poland
Hospital de Cascais
Alcabideche, Lisbon District, Portugal
CHS - Hospital Sao Bernardo
Setúbal, Setúbal District, Portugal
CHL - Hospital Santo Andre
Leiria, , Portugal
CHLO - Hospital Sao Francisco Xavier
Lisbon, , Portugal
Hospital da Luz - Lisboa
Lisbon, , Portugal
CHUP - Hospital Santo Antonio
Porto, , Portugal
Hospital Álvaro Cunqueiro
Babio - Beade, Pontevedra, Spain
Hospital del Mar
Barcelona, , Spain
Hospital Ramón y Cajal
Madrid, , Spain
Hospital Virgen de la Victoria
Málaga, , Spain
Hospital Clínico Universitario de Valencia
Valencia, , Spain
Hospital General Universitario de Valencia
Valencia, , Spain
Hospital Universitari i Politècnic La Fe
Valencia, , Spain
Countries
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References
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Udelson JE, Goldsmith SR, Burkhoff D, Colorado P, Dinh W, Gustafsson F, Kolkhof P, Staedtler G, Bachmakov I, Voors AA, Duarte K, Monzo L, Girerd N, Zannad F. A multicentre, randomized, double-blind, active and placebo-controlled study of pecavaptan, a dual V1a/V2 vasopressin receptor antagonist, in patients with acute heart failure: The AVANTI trial. Eur J Heart Fail. 2025 Aug 11. doi: 10.1002/ejhf.3801. Online ahead of print.
Kazory A. Combination Diuretic Therapy to Counter Renal Sodium Avidity in Acute Heart Failure: Trials and Tribulations. Clin J Am Soc Nephrol. 2023 Oct 1;18(10):1372-1381. doi: 10.2215/CJN.0000000000000188. Epub 2023 Apr 27.
Goldsmith SR, Burkhoff D, Gustafsson F, Voors A, Zannad F, Kolkhof P, Staedtler G, Colorado P, Dinh W, Udelson JE. Dual Vasopressin Receptor Antagonism to Improve Congestion in Patients With Acute Heart Failure: Design of the AVANTI Trial. J Card Fail. 2021 Feb;27(2):233-241. doi: 10.1016/j.cardfail.2020.10.007. Epub 2020 Oct 24.
Related Links
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Click here to find information about studies related to Bayer Healthcare products conducted in Europe.
Other Identifiers
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2018-004059-18
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
17909
Identifier Type: -
Identifier Source: org_study_id
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