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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03901729
Recruitment Status : Recruiting
First Posted : April 3, 2019
Last Update Posted : October 24, 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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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: October 24, 2019
Last Verified: October 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