A Trial to Study BAY1753011 in Patients With Congestive Heart Failure
- Conditions
- Heart Failure (HF)
- Interventions
- Registration Number
- NCT03901729
- Lead Sponsor
- Bayer
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 482
-
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.
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 2 Placebo BAY 1753011 Placebo of BAY1753011 in addition to SoC for part A and part B Arm 2-B Placebo BAY 1753011 Furosemide 80mg in addition to Placebo BAY1753011 30mg for part B Arm 1-A Placebo Furosemide BAY1753011 30mg in addition to Placebo Furosemide 80mg for part B Arm 1-B Placebo BAY 1753011 Furosemide 80mg in addition to Placebo BAY1753011 30mg for part B Arm 1 BAY 1753011 BAY1753011 30mg in addition to standard of care (SoC) for part A and part B Arm 1-A BAY 1753011 BAY1753011 30mg in addition to Placebo Furosemide 80mg for part B Arm 2-A BAY 1753011 BAY1753011 30mg in addition to Placebo Furosemide 80mg for part B Arm 2-A Placebo Furosemide BAY1753011 30mg in addition to Placebo Furosemide 80mg for part B Arm 1-B Furosemide Furosemide 80mg in addition to Placebo BAY1753011 30mg for part B Arm 2-B Furosemide Furosemide 80mg in addition to Placebo BAY1753011 30mg for part B
- Primary Outcome Measures
Name Time Method PART A: Change in serum creatinine Compare Day 30 (End of part A) with Day 1 (Start of part A) PART B: Change in body weight Compare Day 60 (End of part B) with Day 30 (Start of part B) PART A: Change in body weight Compare Day 30 (End of part A) with Day 1 (Start of part A) PART B: Change in log transformed blood urea nitrogen (BUN)/creatinine ratio Compare Day 60 (End of part B) with Day 30 (Start of part B)
- Secondary Outcome Measures
Name Time Method Incidence of Treatment-emergent adverse event (including Serious adverse event) From the time of first study drug administration up to 7 days after the last dose of study drug (Day 60) Change in augmentation index Up to 60 days
Trial Locations
- Locations (66)
Universitätsklinikum St. Pölten
🇦🇹St. Pölten, Niederösterreich, Austria
Medizinische Universität Graz
🇦🇹Graz, Steiermark, Austria
Universitätsklinikum AKH Wien
🇦🇹Wien, Austria
MHAT Haskovo
🇧🇬Haskovo, Bulgaria
Spec Hosp for Active Treatm in Cardiology Sv Georgi Pernik
🇧🇬Pernik, Bulgaria
Multiprofile Hospital for Active Treatment Medline Clinic
🇧🇬Plovdiv, Bulgaria
UMHAT Dr. Georgi Stranski
🇧🇬Pleven, Bulgaria
MHAT "Knyaginya Klementina - Sofia"EAD
🇧🇬Sofia, Bulgaria
NMTH Tzar Boris III
🇧🇬Sofia, Bulgaria
UMHAT Tsaritsa Joanna-ISUL EAD Sofia
🇧🇬Sofia, Bulgaria
G. GENNIMATAS General State Hospital of Athens
🇬🇷Athens, Greece
University General Hospital of Ioannina
🇬🇷Ioannina, Greece
Univ. General Hospital of Larissa
🇬🇷Larissa, Greece
"AHEPA" University General Hospital of Thessaloniki
🇬🇷Thessaloniki, Greece
Budai Irgalmasrendi Korhaz
🇭🇺Budapest, Hungary
University of Semmelweis/ Semmelweis Egyetem
🇭🇺Budapest, Hungary
Kanizsai Dorottya Hospital
🇭🇺Nagykanizsa, Hungary
Magyar Honvedseg Egeszsegugyi Kozpont Honvedkorhaz
🇭🇺Budapest, Hungary
Tolna Megyei Balassa Janos Korhaz
🇭🇺Szekszard, Hungary
Rambam Health Corporation
🇮🇱Haifa, Israel
Health Corporation of Galilee Medical Center
🇮🇱Nahariya, Israel
ASST Spedali Civili di Brescia
🇮🇹Brescia, Lombardia, Italy
A.O.U. di Ferrara
🇮🇹Ferrara, Emilia-Romagna, Italy
AUSL Toscana Sud-Est
🇮🇹Arezzo, Toscana, Italy
A.O.U. Senese
🇮🇹Siena, Toscana, Italy
10 Wojskowy Szpital Kliniczny z Poliklinika SPZOZ
🇵🇱Bydgoszcz, Poland
Samodzielny Publiczny Specjalistyczny Szpital Zachodni
🇵🇱Grodzisk Mazowiecki, Poland
Szpital Wojewodzki Nr 2
🇵🇱Rzeszow, Poland
Uniwersyteckie Centrum Kliniczne Warszawskiego UM
🇵🇱Warszawa, Poland
Uniwersytecki Szpital Kliniczny UM we Wroclawiu
🇵🇱Wroclaw, Poland
Hospital de Cascais
🇵🇹Alcabideche, Lisboa, Portugal
CHS - Hospital Sao Bernardo
🇵🇹Setubal, Setúbal, Portugal
CHL - Hospital Santo Andre
🇵🇹Leiria, Portugal
Hospital da Luz - Lisboa
🇵🇹Lisboa, Portugal
CHUP - Hospital Santo Antonio
🇵🇹Porto, Portugal
CHLO - Hospital Sao Francisco Xavier
🇵🇹Lisboa, Portugal
Hospital Álvaro Cunqueiro
🇪🇸Babio - Beade, Pontevedra, Spain
Hospital del Mar
🇪🇸Barcelona, Spain
Hospital Ramón y Cajal
🇪🇸Madrid, Spain
Hospital Clínico Universitario de Valencia
🇪🇸Valencia, Spain
Hospital Virgen de la Victoria
🇪🇸Málaga, Spain
Hospital General Universitario de Valencia
🇪🇸Valencia, Spain
Hospital Universitari i Politècnic La Fe
🇪🇸Valencia, Spain
University General Hospital of Athens "ATTIKON"
🇬🇷Chaidari - Athens, Greece
ASST Papa Giovanni XXIII
🇮🇹Bergamo, Lombardia, Italy
IRCCS Centro Cardiologico Monzino S.p.A
🇮🇹Milano, Lombardia, Italy
Fondazione Policlinico di Monza
🇮🇹Monza Brianza, Lombardia, Italy
Fondazione Toscana Gabriele Monasterio (FTGM)
🇮🇹Pisa, Toscana, Italy
AUSL della Romagna
🇮🇹Rimini, Emilia-Romagna, Italy
Zala Megyei Szent Rafael Korhaz
🇭🇺Zalaegerszeg, Hungary
Shamir Medical Center (Assaf Harofeh)
🇮🇱Zrifin, Israel
KAT General Hospital of Athens
🇬🇷Kifisia / Athens, Attica, Greece
Tel-Aviv Sourasky Medical Center
🇮🇱Tel Aviv, Israel
Uniwersytecki Szpital Kliniczny w Bialymstoku
🇵🇱Bialystok, Poland
Szpital Kliniczny Przemienienia Panskiego
🇵🇱Poznan, Poland
Krankenhaus St. Josef Braunau
🇦🇹Braunau, Oberösterreich, Austria
Klinik Floridsdorf - Krankenhaus Nord
🇦🇹Wien, Austria
Hippokration General Hospital of Thessaloniki
🇬🇷Thessaloniki, Greece
Hadassah Hebrew University Hospital Ein Kerem
🇮🇱Jerusalem, Israel
Konstantopoulio General Hospital of Nea Ionia - AGIA OLGA
🇬🇷Nea Ionia / Athens, Greece
Josa Andras Hospital
🇭🇺Nyiregyhaza, Hungary
Barzilai Medical Center
🇮🇱Ashkelon, Israel
Chaim Sheba Medical Center
🇮🇱Ramat Gan, Israel
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
🇭🇺Szekesfehervar, Hungary
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz
🇭🇺Szolnok, Hungary
Szpital sw. Wincentego a Paulo
🇵🇱Gdynia, Poland