Trial Condition(s):
Heart failure (HF)
A trial to study BAY1753011 in patients with Congestive Heart Failure (AVANTI)
Bayer Identifier:
17909
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations CHLO - Hospital Sao Francisco Xavier Lisboa, Portugal, 1449-005 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital da Luz - Lisboa Lisboa, Portugal, 1500-650 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations CHUP - Hospital Santo Antonio Porto, Portugal, 4099-001 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations CHS - Hospital Sao Bernardo Setubal, Portugal, 2900-446 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Universitätsklinikum St. Pölten St. Pölten, Austria, 3100 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Klinik Floridsdorf - Krankenhaus Nord Wien, Austria, 1210 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Medizinische Universität Graz Graz, Austria, 8036 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Shamir Medical Center (Assaf Harofeh) Zrifin, Israel, 7030000 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hadassah Hebrew University Hospital Ein Kerem Jerusalem, Israel, 9112001 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Krankenhaus St. Josef Braunau Braunau, Austria, 5280 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Universitätsklinikum AKH Wien Wien, Austria, 1090 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations ASST Papa Giovanni XXIII Bergamo, Italy, 24127 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations IRCCS Centro Cardiologico Monzino S.p.A Milano, Italy, 20138 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations ASST Spedali Civili di Brescia Brescia, Italy, 25123 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fondazione Policlinico di Monza Monza Brianza, Italy, 20900 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations A.O.U. di Ferrara Ferrara, Italy, 44124 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations AUSL della Romagna Rimini, Italy, 47923 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fondazione Toscana Gabriele Monasterio (FTGM) Pisa, Italy, 56124 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations AUSL Toscana Sud-Est Arezzo, Italy, 52044 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University General Hospital of Athens "ATTIKON" Chaidari - Athens, Greece, 12462 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations G. GENNIMATAS General State Hospital of Athens Athens, Greece, 11527 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Konstantopoulio General Hospital of Nea Ionia - AGIA OLGA Nea Ionia / Athens, Greece, 142 33 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations KAT General Hospital of Athens Kifisia / Athens, Greece, 14561 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Univ. General Hospital of Larissa Larissa, Greece, 41100 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hippokration General Hospital of Thessaloniki Thessaloniki, Greece, 54642 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations “AHEPA” University General Hospital of Thessaloniki Thessaloniki, Greece, 54636 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University General Hospital of Ioannina Ioannina, Greece, 45500 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Rambam Health Corporation Haifa, Israel, 3109601 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Chaim Sheba Medical Center Ramat Gan, Israel, 5262000 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations UMHAT Tsaritsa Joanna-ISUL EAD Sofia Sofia, Bulgaria, 1527 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations NMTH Tzar Boris III Sofia, Bulgaria, 1233 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations MHAT "Knyaginya Klementina - Sofia"EAD Sofia, Bulgaria, 1233 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Spec Hosp for Active Treatm in Cardiology Sv Georgi Pernik Pernik, Bulgaria, 2300 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations UMHAT Dr. Georgi Stranski Pleven, Bulgaria, 5800 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations MHAT Haskovo Haskovo, Bulgaria, 6300 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Tolna Megyei Balassa Janos Korhaz Szekszard, Hungary, 7100 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz Szekesfehervar, Hungary, 8000 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Josa Andras Hospital Nyiregyhaza, Hungary, H-4400 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Budai Irgalmasrendi Korhaz Budapest, Hungary, 1023 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Zala Megyei Szent Rafael Korhaz Zalaegerszeg, Hungary, 8900 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Barzilai Medical Center Ashkelon, Israel, 7830604 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Tel-Aviv Sourasky Medical Center Tel Aviv, Israel, 6423906 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations 10 Wojskowy Szpital Kliniczny z Poliklinika SPZOZ Bydgoszcz, Poland, 85-681 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Samodzielny Publiczny Specjalistyczny Szpital Zachodni Grodzisk Mazowiecki, Poland, 05-825 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Uniwersytecki Szpital Kliniczny w Bialymstoku Bialystok, Poland, 15-276 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Szpital Kliniczny Przemienienia Panskiego Poznan, Poland, 61-848 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Uniwersytecki Szpital Kliniczny UM we Wroclawiu Wroclaw, Poland, 50-556 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Szpital Wojewodzki Nr 2 Rzeszow, Poland, 35-301 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Magyar Honvedseg Egeszsegugyi Kozpont Honvedkorhaz Budapest, Hungary | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University of Semmelweis/ Semmelweis Egyetem Budapest, Hungary, 1122 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz Szolnok, Hungary, 5000 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital de Cascais Alcabideche, Portugal, 2755-009 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Universitari i Politècnic La Fe Valencia, Spain, 46026 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Virgen de la Victoria Málaga, Spain, 29010 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Ramón y Cajal Madrid, Spain, 28034 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital del Mar Barcelona, Spain, 08003 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Clínico Universitario de Valencia Valencia, Spain, 46010 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital General Universitario de Valencia Valencia, Spain, 46014 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Multiprofile Hospital for Active Treatment Medline Clinic Plovdiv, Bulgaria, 4000 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Szpital sw. Wincentego a Paulo Gdynia, Poland, 81-348 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Uniwersyteckie Centrum Kliniczne Warszawskiego UM Warszawa, Poland, 02-097 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations A.O.U. Senese Siena, Italy, 53100 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Health Corporation of Galilee Medical Center Nahariya, Israel, 22100 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kanizsai Dorottya Hospital Nagykanizsa, Hungary, 8800 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Álvaro Cunqueiro Babio - Beade, Spain, 36312 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations CHL - Hospital Santo Andre Leiria, Portugal, 2410-197 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Trial Design
A Multicenter, Randomized, Parallel Group, Double Blind, Active and Placebo Controlled Study of BAY1753011, a Dual V1a/V2 Vasopressin Receptor Antagonist, in Patients with Congestive Heart Failure: AVANTI Study
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
N/A
Assignment:
Parallel Assignment
Trial Arms:
6
Primary Outcome
- PART A: Change in body weightTimeframe: Compare Day 30 (End of part A) with Day 1 (Start of part A)
- PART A: Change in serum creatinineTimeframe: Compare Day 30 (End of part A) with Day 1 (Start of part A)
- PART B: Change in body weightTimeframe: Compare Day 60 (End of part B) with Day 30 (Start of part B)
- PART B: Change in log transformed blood urea nitrogen (BUN)/creatinine ratioTimeframe: Compare Day 60 (End of part B) with Day 30 (Start of part B)
Secondary Outcome
- Incidence of Treatment-emergent adverse event (including Serious adverse event)Timeframe: From the time of first study drug administration up to 7 days after the last dose of study drug (Day 60)
- Change in augmentation indexTimeframe: Up to 60 days
Additional Information
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