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A Trial to Study BAY1753011 in Patients With Congestive Heart Failure (AVANTI)

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ClinicalTrials.gov Identifier: NCT03901729
Recruitment Status : Recruiting
First Posted : April 3, 2019
Last Update Posted : November 22, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Heart Failure (HF) Drug: BAY 1753011 Other: Placebo BAY 1753011 Drug: Furosemide Other: Placebo Furosemide Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 414 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : May 29, 2019
Estimated Primary Completion Date : June 16, 2020
Estimated Study Completion Date : July 21, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: Arm 1
BAY1753011 30mg in addition to standard of care (SoC) for part A and part B
Drug: BAY 1753011
Tablet; 30mg or 5mg unit; 30mg once daily in the morning; Oral

Placebo Comparator: Arm 2
Placebo of BAY1753011 in addition to SoC for part A and part B
Other: Placebo BAY 1753011
Tablet; Once daily in the morning; Oral

Experimental: Arm 1-A
BAY1753011 30mg in addition to Placebo Furosemide 80mg for part B
Drug: BAY 1753011
Tablet; 30mg or 5mg unit; 30mg once daily in the morning; Oral

Other: Placebo Furosemide
Tablet; Once daily in the morning; Oral

Active Comparator: Arm 1-B
Furosemide 80mg in addition to Placebo BAY1753011 30mg for part B
Other: Placebo BAY 1753011
Tablet; Once daily in the morning; Oral

Drug: Furosemide
Tablet; 40mg unit; 80mg once daily in the morning; Oral

Experimental: Arm 2-A
BAY1753011 30mg in addition to Placebo Furosemide 80mg for part B
Drug: BAY 1753011
Tablet; 30mg or 5mg unit; 30mg once daily in the morning; Oral

Other: Placebo Furosemide
Tablet; Once daily in the morning; Oral

Active Comparator: Arm 2-B
Furosemide 80mg in addition to Placebo BAY1753011 30mg for part B
Other: Placebo BAY 1753011
Tablet; Once daily in the morning; Oral

Drug: Furosemide
Tablet; 40mg unit; 80mg once daily in the morning; Oral




Primary Outcome Measures :
  1. PART A: Change in body weight [ Time Frame: Compare Day 30 (End of part A) with Day 1 (Start of part A) ]
  2. PART A: Change in serum creatinine [ Time Frame: Compare Day 30 (End of part A) with Day 1 (Start of part A) ]
  3. PART B: Change in body weight [ Time Frame: Compare Day 60 (End of part B) with Day 30 (Start of part B) ]
  4. PART B: Change in BUN/creatinine ratio [ Time Frame: Compare Day 60 (End of part B) with Day 30 (Start of part B) ]
    BUN:Blood urea nitrogen


Secondary Outcome Measures :
  1. Incidence of Treatment-emergent adverse event (including Serious adverse event) [ Time Frame: Up to 60 days ]
  2. Change in augmentation index [ Time Frame: Up to 60 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  • Patients 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).
  • 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) ≥ 2
    • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03901729


Contacts
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Contact: Bayer Clinical Trials Contact (+)1-888-84 22937 clinical-trials-contact@bayer.com

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Locations
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Austria
Universitätsklinikum St. Pölten Recruiting
St. Pölten, Niederösterreich, Austria, 3100
Krankenhaus St. Josef Braunau Recruiting
Braunau, Oberösterreich, Austria, 5280
Krankenhaus der Elisabethinen Linz GmbH Not yet recruiting
Linz, Oberösterreich, Austria, 4020
Medizinische Universität Graz Recruiting
Graz, Steiermark, Austria, 8036
Allgemeines Krankenhaus der Stadt Wien Recruiting
Wien, Austria, 1090
Krankenhauses Nord - Klinik Floridsdorf Recruiting
Wien, Austria, 1210
Bulgaria
MHAT Haskovo Recruiting
Haskovo, Bulgaria, 6300
Spec Hosp for Active Treatm in Cardiology Sv Georgi Pernik Recruiting
Pernik, Bulgaria, 2300
Specialized Hospital for Actrive Treatm of Card - Pleven Not yet recruiting
Pleven, Bulgaria, 5800
UMHAT Dr. Georgi Stranski Recruiting
Pleven, Bulgaria, 5800
Multiprofile Hospital for Active Treatment Medline Clinic Recruiting
Plovdiv, Bulgaria, 4000
UMHAT Sveti Georgi Withdrawn
Plovdiv, Bulgaria, 4002
NMTH Tzar Boris III Recruiting
Sofia, Bulgaria, 1233
V MHAT Recruiting
Sofia, Bulgaria, 1233
UMHAT Tsaritsa Joanna-ISUL EAD Sofia Recruiting
Sofia, Bulgaria, 1527
Germany
Herz- und Diabeteszentrum Nordrhein-Westfalen (HDZ NRW) Withdrawn
Bad Oeynhausen, Nordrhein-Westfalen, Germany, 32545
Universitätsklinikum Essen Withdrawn
Essen, Nordrhein-Westfalen, Germany, 45147
Kliniken Maria Hilf GmbH Withdrawn
Mönchengladbach, Nordrhein-Westfalen, Germany, 41063
Forschungszentrum Ruhr - KliFoCenter GmbH Withdrawn
Witten, Nordrhein-Westfalen, Germany, 58455
St. Vincenz und Elisabeth Hospital, Kathol. Klinikum Mainz Withdrawn
Mainz, Rheinland-Pfalz, Germany, 55131
Charité Campus Virchow-Klinikum (CVK) Withdrawn
Berlin, Germany, 13353
Albertinen-Krankenhaus gemeinnützige GmbH Withdrawn
Hamburg, Germany, 22457
Greece
KAT General Hospital of Athens Recruiting
Kifisia / Athens, Attica, Greece, 14561
G. Gennimatas General State Hospital of Athens Recruiting
Athens, Greece, 11527
University General Hospital of Athens "ATTIKON" Not yet recruiting
Chaidari - Athens, Greece, 12462
University General Hospital of Ioannina Not yet recruiting
Ioannina, Greece, 45500
University General Hospital of Larissa Recruiting
Larissa, Greece, 41100
Konstantopoulio General Hospital of Nea Ionia - Agia Olga Recruiting
Nea Ionia / Athens, Greece, 142 33
University General Hospital of Thessaloniki "AHEPA" Recruiting
Thessaloniki, Greece, 54636
Hippokration General Hospital of Thessaloniki Not yet recruiting
Thessaloniki, Greece, 54642
Hungary
Allami Szivkorhaz Not yet recruiting
Balatonfured, Hungary, 8230
Budai Irgalmasrendi Korhaz Recruiting
Budapest, Hungary, 1023
University of Semmelweis/ Semmelweis Egyetem Recruiting
Budapest, Hungary, 1122
Magyar Honvedseg Egeszsegugyi Kozpont Honvedkorhaz Recruiting
Budapest, Hungary
Kanizsai Dorottya Hospital Not yet recruiting
Nagykanizsa, Hungary, 8800
Josa Andras Hospital Not yet recruiting
Nyiregyhaza, Hungary, H-4400
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz Recruiting
Szekesfehervar, Hungary, 8000
Tolna Megyei Balassa Janos Korhaz Recruiting
Szekszard, Hungary, 7100
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz Not yet recruiting
Szolnok, Hungary, 5000
Zala Megyei Szent Rafael Korhaz Not yet recruiting
Zalaegerszeg, Hungary, 8900
Israel
Barzilai Medical Center Not yet recruiting
Ashkelon, Israel, 7830604
Soroka University Medical Center Not yet recruiting
Be'er Sheva, Israel, 84101
Rambam Health Corporation Recruiting
Haifa, Israel, 3109601
Hadassah Hebrew University Hospital Ein Kerem Not yet recruiting
Jerusalem, Israel, 9112001
Health Corporation of Galilee Medical Center Withdrawn
Nahariya, Israel, 22100
Health Corporation of Galilee Medical Center Recruiting
Nahariya, Israel, 22100
Chaim Sheba Medical Center Not yet recruiting
Ramat Gan, Israel, 5262000
Kaplan Medical Center Withdrawn
Rehovot, Israel, 7610001
Tel-Aviv Sourasky Medical Center Recruiting
Tel Aviv, Israel, 6423906
Shamir Medical Center (Assaf Harofeh) Recruiting
Zrifin, Israel, 6093000
Italy
A.O.U. di Ferrara Arcispedale S.Anna Recruiting
Ferrara, Emilia-Romagna, Italy, 44124
AUSL della Romagna Recruiting
Rimini, Emilia-Romagna, Italy, 47923
ASST Papa Giovanni XXIII Recruiting
Bergamo, Lombardia, Italy, 24127
ASST Spedali Civili di Brescia Recruiting
Brescia, Lombardia, Italy, 25123
IRCCS Centro Cardiologico Monzino Recruiting
Milano, Lombardia, Italy, 20138
Fondazione Policlinico di Monza Not yet recruiting
Monza-Brianza, Lombardia, Italy, 20900
AUSL Toscana Sud-Est Recruiting
Arezzo, Toscana, Italy, 52040
Fondazione Toscana Gabriele Monasterio (FTGM) Recruiting
Pisa, Toscana, Italy, 56124
A.O.U. Senese Recruiting
Siena, Toscana, Italy, 53100
ULSS3 Serenissima Not yet recruiting
Venezia, Veneto, Italy, 30015
Poland
Uniwersytecki Szpital Kliniczny w Bialymstoku Recruiting
Bialystok, Poland, 15-276
10 Wojskowy Szpital Kliniczny z Poliklinika SPZOZ Recruiting
Bydgoszcz, Poland, 85-681
Szpital sw. Wincentego a Paulo Recruiting
Gdynia, Poland, 81-348
Samodzielny Publiczny Szpital Kliniczny Szpital Zachodni Recruiting
Grodzisk Mazowiecki, Poland, 05-825
Szpital Kliniczny Przemienienia Panskiego Recruiting
Poznan, Poland, 61-848
Szpital Wojewodzki Nr 2 Recruiting
Rzeszow, Poland, 35-301
Uniwersyteckie Centrum Kliniczne Warszawskiego UM Recruiting
Warszawa, Poland, 02-097
Uniwersytecki Szpital Kliniczny UM we Wroclawiu Recruiting
Wroclaw, Poland, 50-556
Portugal
Hospital de Cascais Not yet recruiting
Alcabideche, Lisboa, Portugal, 2755-009
CHLO - Hospital Santa Cruz Not yet recruiting
Carnaxide, Lisboa, Portugal, 2795-53
CHS - Hospital Sao Bernardo Not yet recruiting
Setubal, Setúbal, Portugal, 2900-446
CHL - Hospital Santo Andre Not yet recruiting
Leiria, Portugal, 2410-197
CHLO - Hospital Sao Francisco Xavier Not yet recruiting
Lisboa, Portugal, 1449-005
Hospital da Luz Recruiting
Lisboa, Portugal, 1500-650
CHUP - Hospital Santo Antonio Not yet recruiting
Porto, Portugal, 4099-001
Spain
Hospital Clínico Universitario de Santiago de Compostela Not yet recruiting
Santiago de Compostela, A Coruña, Spain, 15706
Hospital Álvaro Cunqueiro Not yet recruiting
Babio - Beade, Pontevedra, Spain, 36312
Hospital del Mar Recruiting
Barcelona, Spain, 08003
Hospital Ramón y Cajal Recruiting
Madrid, Spain, 28034
Hospital Virgen de la Victoria Recruiting
Málaga, Spain, 29010
Hospital Clínico Universitario de Valencia Recruiting
Valencia, Spain, 46010
Hospital General Universitario de Valencia Recruiting
Valencia, Spain, 46014
Hospital Universitari i Politècnic La Fe Recruiting
Valencia, Spain, 46026
Sponsors and Collaborators
Bayer

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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT03901729     History of Changes
Other Study ID Numbers: 17909
First Posted: April 3, 2019    Key Record Dates
Last Update Posted: November 22, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access.

As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.


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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bayer:
Chronic heart failure (CHF)
Heart failure with reduced ejection fraction (HFrEF)
Heart failure with preserved ejection fraction (HFpEF)
Heart failure with mid-range ejection fraction (HFmrEF)
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases
Furosemide
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Potassium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action