Trial Condition(s):

Heart failure (HF)

A trial to study BAY1753011 in patients with Congestive Heart Failure (AVANTI)

Bayer Identifier:

17909

ClinicalTrials.gov Identifier:

NCT03901729

EudraCT Number:

2018-004059-18

Study Completed

Trial Purpose

To assess the efficacy of 30 mg of BAY1753011, with or without furosemide, versus furosemide alone in patients with heart failure and objective evidence of congestion.

Inclusion Criteria
:
- History of CHF on individually optimized treatment with HF medications unless contraindicated or not tolerated, for at least 12 weeks prior to index hospitalization and in accordance with international guidelines.
- 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
- Active or history of acute inflammatory heart disease, within 3 months prior to screening, e.g., acute myocarditis
- 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.

Trial Summary

Enrollment Goal
482
Trial Dates
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Phase
2
Could I receive a placebo?
Yes
Products
BAY1753011
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

CHLO - Hospital Sao Francisco Xavier

Lisboa, Portugal, 1449-005

Status
Completed
 
Locations

Hospital da Luz - Lisboa

Lisboa, Portugal, 1500-650

Status
Completed
 
Locations

CHUP - Hospital Santo Antonio

Porto, Portugal, 4099-001

Status
Completed
 
Locations

CHS - Hospital Sao Bernardo

Setubal, Portugal, 2900-446

Status
Completed
 
Locations

Universitätsklinikum St. Pölten

St. Pölten, Austria, 3100

Status
Completed
 
Locations

Klinik Floridsdorf - Krankenhaus Nord

Wien, Austria, 1210

Status
Completed
 
Locations

Medizinische Universität Graz

Graz, Austria, 8036

Status
Completed
 
Locations

Shamir Medical Center (Assaf Harofeh)

Zrifin, Israel, 7030000

Status
Completed
 
Locations

Hadassah Hebrew University Hospital Ein Kerem

Jerusalem, Israel, 9112001

Status
Completed
 
Locations

Krankenhaus St. Josef Braunau

Braunau, Austria, 5280

Status
Completed
 
Locations

Universitätsklinikum AKH Wien

Wien, Austria, 1090

Status
Completed
 
Locations

ASST Papa Giovanni XXIII

Bergamo, Italy, 24127

Status
Completed
 
Locations

IRCCS Centro Cardiologico Monzino S.p.A

Milano, Italy, 20138

Status
Completed
 
Locations

ASST Spedali Civili di Brescia

Brescia, Italy, 25123

Status
Completed
 
Locations

Fondazione Policlinico di Monza

Monza Brianza, Italy, 20900

Status
Completed
 
Locations

A.O.U. di Ferrara

Ferrara, Italy, 44124

Status
Completed
 
Locations

AUSL della Romagna

Rimini, Italy, 47923

Status
Completed
 
Locations

Fondazione Toscana Gabriele Monasterio (FTGM)

Pisa, Italy, 56124

Status
Completed
 
Locations

AUSL Toscana Sud-Est

Arezzo, Italy, 52044

Status
Completed
 
Locations

University General Hospital of Athens "ATTIKON"

Chaidari - Athens, Greece, 12462

Status
Completed
 
Locations

G. GENNIMATAS General State Hospital of Athens

Athens, Greece, 11527

Status
Completed
 
Locations

Konstantopoulio General Hospital of Nea Ionia - AGIA OLGA

Nea Ionia / Athens, Greece, 142 33

Status
Completed
 
Locations

KAT General Hospital of Athens

Kifisia / Athens, Greece, 14561

Status
Completed
 
Locations

Univ. General Hospital of Larissa

Larissa, Greece, 41100

Status
Completed
 
Locations

Hippokration General Hospital of Thessaloniki

Thessaloniki, Greece, 54642

Status
Completed
 
Locations

“AHEPA” University General Hospital of Thessaloniki

Thessaloniki, Greece, 54636

Status
Completed
 
Locations

University General Hospital of Ioannina

Ioannina, Greece, 45500

Status
Completed
 
Locations

Rambam Health Corporation

Haifa, Israel, 3109601

Status
Completed
 
Locations

Chaim Sheba Medical Center

Ramat Gan, Israel, 5262000

Status
Completed
 
Locations

UMHAT Tsaritsa Joanna-ISUL EAD Sofia

Sofia, Bulgaria, 1527

Status
Completed
 
Locations

NMTH Tzar Boris III

Sofia, Bulgaria, 1233

Status
Completed
 
Locations

MHAT "Knyaginya Klementina - Sofia"EAD

Sofia, Bulgaria, 1233

Status
Completed
 
Locations

Spec Hosp for Active Treatm in Cardiology Sv Georgi Pernik

Pernik, Bulgaria, 2300

Status
Completed
 
Locations

UMHAT Dr. Georgi Stranski

Pleven, Bulgaria, 5800

Status
Completed
 
Locations

MHAT Haskovo

Haskovo, Bulgaria, 6300

Status
Completed
 
Locations

Tolna Megyei Balassa Janos Korhaz

Szekszard, Hungary, 7100

Status
Completed
 
Locations

Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

Szekesfehervar, Hungary, 8000

Status
Completed
 
Locations

Josa Andras Hospital

Nyiregyhaza, Hungary, H-4400

Status
Completed
 
Locations

Budai Irgalmasrendi Korhaz

Budapest, Hungary, 1023

Status
Completed
 
Locations

Zala Megyei Szent Rafael Korhaz

Zalaegerszeg, Hungary, 8900

Status
Completed
 
Locations

Barzilai Medical Center

Ashkelon, Israel, 7830604

Status
Completed
 
Locations

Tel-Aviv Sourasky Medical Center

Tel Aviv, Israel, 6423906

Status
Completed
 
Locations

10 Wojskowy Szpital Kliniczny z Poliklinika SPZOZ

Bydgoszcz, Poland, 85-681

Status
Completed
 
Locations

Samodzielny Publiczny Specjalistyczny Szpital Zachodni

Grodzisk Mazowiecki, Poland, 05-825

Status
Completed
 
Locations

Uniwersytecki Szpital Kliniczny w Bialymstoku

Bialystok, Poland, 15-276

Status
Completed
 
Locations

Szpital Kliniczny Przemienienia Panskiego

Poznan, Poland, 61-848

Status
Completed
 
Locations

Uniwersytecki Szpital Kliniczny UM we Wroclawiu

Wroclaw, Poland, 50-556

Status
Completed
 
Locations

Szpital Wojewodzki Nr 2

Rzeszow, Poland, 35-301

Status
Completed
 
Locations

Magyar Honvedseg Egeszsegugyi Kozpont Honvedkorhaz

Budapest, Hungary

Status
Completed
 
Locations

University of Semmelweis/ Semmelweis Egyetem

Budapest, Hungary, 1122

Status
Completed
 
Locations

Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz

Szolnok, Hungary, 5000

Status
Completed
 
Locations

Hospital de Cascais

Alcabideche, Portugal, 2755-009

Status
Completed
 
Locations

Hospital Universitari i Politècnic La Fe

Valencia, Spain, 46026

Status
Completed
 
Locations

Hospital Virgen de la Victoria

Málaga, Spain, 29010

Status
Completed
 
Locations

Hospital Ramón y Cajal

Madrid, Spain, 28034

Status
Completed
 
Locations

Hospital del Mar

Barcelona, Spain, 08003

Status
Completed
 
Locations

Hospital Clínico Universitario de Valencia

Valencia, Spain, 46010

Status
Completed
 
Locations

Hospital General Universitario de Valencia

Valencia, Spain, 46014

Status
Completed
 
Locations

Multiprofile Hospital for Active Treatment Medline Clinic

Plovdiv, Bulgaria, 4000

Status
Completed
 
Locations

Szpital sw. Wincentego a Paulo

Gdynia, Poland, 81-348

Status
Completed
 
Locations

Uniwersyteckie Centrum Kliniczne Warszawskiego UM

Warszawa, Poland, 02-097

Status
Completed
 
Locations

A.O.U. Senese

Siena, Italy, 53100

Status
Completed
 
Locations

Health Corporation of Galilee Medical Center

Nahariya, Israel, 22100

Status
Completed
 
Locations

Kanizsai Dorottya Hospital

Nagykanizsa, Hungary, 8800

Status
Completed
 
Locations

Hospital Álvaro Cunqueiro

Babio - Beade, Spain, 36312

Status
Completed
 
Locations

CHL - Hospital Santo Andre

Leiria, Portugal, 2410-197

Status
Completed
 

Trial Design