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Heart Failure (HF)Phase 2AVANTINCT03901729

A Trial to Study BAY1753011 in Patients With Congestive Heart Failure

A Phase 2 study testing BAY 1753011 and Furosemide in people with Heart Failure (HF), run by Bayer at 66 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Heart Failure (HF)
What is being tested?
BAY 1753011 and Furosemide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
482 participants
Where
66 sitesin 9 countries
Study dates
29 May 2019to 21 May 2021
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 15Show fewer
  • 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

Who cannot join

  • 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 locations and contacts

66 sites in 9 countries.

66 sites in 9 countries

Hungary9 sites

  • Budai Irgalmasrendi Korhaz

    Budapest, 1023

  • University of Semmelweis/ Semmelweis Egyetem

    Budapest, 1122

  • Magyar Honvedseg Egeszsegugyi Kozpont Honvedkorhaz

    Budapest

  • Kanizsai Dorottya Hospital

    Nagykanizsa, 8800

  • Josa Andras Hospital

    Nyíregyháza, H-4400

  • Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

    Székesfehérvár, 8000

  • Tolna Megyei Balassa Janos Korhaz

    Szekszárd, 7100

  • Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz

    Szolnok, 5000

  • Zala Megyei Szent Rafael Korhaz

    Zalaegerszeg, 8900

Other trials in Hungary

Italy9 sites

  • AUSL Toscana Sud-Est

    Arezzo, Tuscany, 52044

  • ASST Papa Giovanni XXIII

    Bergamo, Lombardy, 24127

  • ASST Spedali Civili di Brescia

    Brescia, Lombardy, 25123

  • A.O.U. di Ferrara

    Ferrara, Emilia-Romagna, 44124

  • IRCCS Centro Cardiologico Monzino S.p.A

    Milan, Lombardy, 20138

  • Fondazione Policlinico di Monza

    Monza Brianza, Lombardy, 20900

  • Fondazione Toscana Gabriele Monasterio (FTGM)

    Pisa, Tuscany, 56124

  • AUSL della Romagna

    Rimini, Emilia-Romagna, 47923

  • A.O.U. Senese

    Siena, Tuscany, 53100

Other trials in Italy

Greece8 sites

  • G. GENNIMATAS General State Hospital of Athens

    Athens, 11527

  • University General Hospital of Athens "ATTIKON"

    Chaidari - Athens, 12462

  • University General Hospital of Ioannina

    Ioannina, 45500

  • KAT General Hospital of Athens

    Kifisia / Athens, Attica, 14561

  • Univ. General Hospital of Larissa

    Larissa, 41100

  • Konstantopoulio General Hospital of Nea Ionia - AGIA OLGA

    Nea Ionia / Athens, 142 33

  • "AHEPA" University General Hospital of Thessaloniki

    Thessaloniki, 54636

  • Hippokration General Hospital of Thessaloniki

    Thessaloniki, 54642

Other trials in Greece

Poland8 sites

  • Uniwersytecki Szpital Kliniczny w Bialymstoku

    Bialystok, 15-276

  • 10 Wojskowy Szpital Kliniczny z Poliklinika SPZOZ

    Bydgoszcz, 85-681

  • Szpital sw. Wincentego a Paulo

    Gdynia, 81-348

  • Samodzielny Publiczny Specjalistyczny Szpital Zachodni

    Grodzisk Mazowiecki, 05-825

  • Szpital Kliniczny Przemienienia Panskiego

    Poznan, 61-848

  • Szpital Wojewodzki Nr 2

    Rzeszów, 35-301

  • Uniwersyteckie Centrum Kliniczne Warszawskiego UM

    Warsaw, 02-097

  • Uniwersytecki Szpital Kliniczny UM we Wroclawiu

    Wroclaw, 50-556

Other trials in Poland

Bulgaria7 sites

  • MHAT Haskovo

    Haskovo, 6300

  • Spec Hosp for Active Treatm in Cardiology Sv Georgi Pernik

    Pernik, 2300

  • UMHAT Dr. Georgi Stranski

    Pleven, 5800

  • Multiprofile Hospital for Active Treatment Medline Clinic

    Plovdiv, 4000

  • MHAT "Knyaginya Klementina - Sofia"EAD

    Sofia, 1233

  • NMTH Tzar Boris III

    Sofia, 1233

  • UMHAT Tsaritsa Joanna-ISUL EAD Sofia

    Sofia, 1527

Other trials in Bulgaria

Israel7 sites

  • Barzilai Medical Center

    Ashkelon, 7830604

  • Rambam Health Corporation

    Haifa, 3109601

  • Hadassah Hebrew University Hospital Ein Kerem

    Jerusalem, 9112001

  • Health Corporation of Galilee Medical Center

    Nahariya, 22100

  • Chaim Sheba Medical Center

    Ramat Gan, 5262000

  • Tel-Aviv Sourasky Medical Center

    Tel Aviv, 6423906

  • Shamir Medical Center (Assaf Harofeh)

    Zrifin, 7030000

Other trials in Israel

Spain7 sites

  • Hospital Álvaro Cunqueiro

    Babio - Beade, Pontevedra, 36312

  • Hospital del Mar

    Barcelona, 08003

  • Hospital Ramón y Cajal

    Madrid, 28034

  • Hospital Virgen de la Victoria

    Málaga, 29010

  • Hospital Clínico Universitario de Valencia

    Valencia, 46010

  • Hospital General Universitario de Valencia

    Valencia, 46014

  • Hospital Universitari i Politècnic La Fe

    Valencia, 46026

Other trials in Spain

Portugal6 sites

  • Hospital de Cascais

    Alcabideche, Lisbon District, 2755-009

  • CHL - Hospital Santo Andre

    Leiria, 2410-197

  • CHLO - Hospital Sao Francisco Xavier

    Lisbon, 1449-005

  • Hospital da Luz - Lisboa

    Lisbon, 1500-650

  • CHUP - Hospital Santo Antonio

    Porto, 4099-001

  • CHS - Hospital Sao Bernardo

    Setúbal, Setúbal District, 2900-446

Other trials in Portugal

Austria5 sites

  • Krankenhaus St. Josef Braunau

    Braunau am Inn, Upper Austria, 5280

  • Medizinische Universität Graz

    Graz, Styria, 8036

  • Universitätsklinikum St. Pölten

    Sankt Pölten, Lower Austria, 3100

  • Universitätsklinikum AKH Wien

    Vienna, 1090

  • Klinik Floridsdorf - Krankenhaus Nord

    Vienna, 1210

Other trials in Austria

About this study

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

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.

Being tested
BAY 1753011, Placebo BAY 1753011, Furosemide, Placebo Furosemide
Keywords
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)
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BAY 1753011Drug

    Tablet; 30mg or 5mg unit; 30mg once daily in the morning; Oral

  • Placebo BAY 1753011Other

    Tablet; Once daily in the morning; Oral

  • FurosemideDrug

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

  • Placebo FurosemideOther

    Tablet; Once daily in the morning; Oral

Study groups in NCT03901729
Study groupRoleWhat they receive
Arm 1ExperimentalBAY1753011 30mg in addition to standard of care (SoC) for part A and part B
Receives: Drug: BAY 1753011
Arm 2Placebo comparatorPlacebo of BAY1753011 in addition to SoC for part A and part B
Receives: Other: Placebo BAY 1753011
Arm 1-AExperimentalBAY1753011 30mg in addition to Placebo Furosemide 80mg for part B
Receives: Drug: BAY 1753011; Other: Placebo Furosemide
Arm 1-BActive comparatorFurosemide 80mg in addition to Placebo BAY1753011 30mg for part B
Receives: Other: Placebo BAY 1753011; Drug: Furosemide
Arm 2-AExperimentalBAY1753011 30mg in addition to Placebo Furosemide 80mg for part B
Receives: Drug: BAY 1753011; Other: Placebo Furosemide
Arm 2-BActive comparatorFurosemide 80mg in addition to Placebo BAY1753011 30mg for part B
Receives: Other: Placebo BAY 1753011; Drug: Furosemide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. PART A: Change in body weight

    Measured: Compare Day 30 (End of part A) with Day 1 (Start of part A)

  2. PART A: Change in serum creatinine

    Measured: Compare Day 30 (End of part A) with Day 1 (Start of part A)

  3. PART B: Change in body weight

    Measured: Compare Day 60 (End of part B) with Day 30 (Start of part B)

  4. PART B: Change in log transformed blood urea nitrogen (BUN)/creatinine ratio

    Measured: Compare Day 60 (End of part B) with Day 30 (Start of part B)

Secondary outcomes (2)

  1. Incidence of Treatment-emergent adverse event (including Serious adverse event)

    Measured: From the time of first study drug administration up to 7 days after the last dose of study drug (Day 60)

  2. Change in augmentation index

    Measured: Up to 60 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Apr 2019
  2. Study start29 May 2019
  3. Primary completion16 Apr 2021
  4. Study completion21 May 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
482 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03901729
Sponsor's protocol ID
17909
Other IDs
2018-004059-18, 2018
Acronym
AVANTI
Status last verified
Apr 2022
First submitted
2 Apr 2019
Last updated
18 Apr 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Availability of this study's data will later 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.

Publications

  • Ceelen DCH, Voordes GHD, Cosic L, Ter Maaten JM, Goldsmith SR, Burkhoff D, Gustafsson F, Frost R, Duarte K, Monzo L, Girerd N, Zannad F, Udelson JE, Voors AA. Short-Term Effects of Pecavaptan on Weight and Congestion in Acute Heart Failure: The AVANTI Post-Hoc Analysis. JACC Adv. 2026 Jul;5(7):102891. doi: 10.1016/j.jacadv.2026.102891.

    PubMed 42489380

  • 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 Nov;27(11):2525-2536. doi: 10.1002/ejhf.3801. Epub 2025 Aug 11.

    PubMed 40788619

  • 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.

    PubMed 37102974

  • 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.

    PubMed 33188886

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BAY 1753011 and Furosemide in people with Heart Failure (HF), run by Bayer at 66 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 66 sites in Hungary, Italy, Greece, Poland, Bulgaria and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PART A: Change in body weight (time frame: Compare Day 30 (End of part A) with Day 1 (Start of part A)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03901729, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2022.

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