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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

Tracking Information
First Submitted Date  ICMJE April 2, 2019
First Posted Date  ICMJE April 3, 2019
Last Update Posted Date November 22, 2019
Actual Study Start Date  ICMJE May 29, 2019
Estimated Primary Completion Date June 16, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 2, 2019)
  • PART A: Change in body weight [ Time Frame: Compare Day 30 (End of part A) with Day 1 (Start of part A) ]
  • PART A: Change in serum creatinine [ Time Frame: Compare Day 30 (End of part A) with Day 1 (Start of part A) ]
  • PART B: Change in body weight [ Time Frame: Compare Day 60 (End of part B) with Day 30 (Start of part B) ]
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03901729 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 2, 2019)
  • Incidence of Treatment-emergent adverse event (including Serious adverse event) [ Time Frame: Up to 60 days ]
  • Change in augmentation index [ Time Frame: Up to 60 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Trial to Study BAY1753011 in Patients With Congestive Heart Failure
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Heart Failure (HF)
Intervention  ICMJE
  • Drug: BAY 1753011
    Tablet; 30mg or 5mg unit; 30mg once daily in the morning; Oral
  • Other: Placebo BAY 1753011
    Tablet; Once daily in the morning; Oral
  • Drug: Furosemide
    Tablet; 40mg unit; 80mg once daily in the morning; Oral
  • Other: Placebo Furosemide
    Tablet; Once daily in the morning; Oral
Study Arms  ICMJE
  • Experimental: Arm 1
    BAY1753011 30mg in addition to standard of care (SoC) for part A and part B
    Intervention: Drug: BAY 1753011
  • Placebo Comparator: Arm 2
    Placebo of BAY1753011 in addition to SoC for part A and part B
    Intervention: Other: Placebo BAY 1753011
  • Experimental: Arm 1-A
    BAY1753011 30mg in addition to Placebo Furosemide 80mg for part B
    Interventions:
    • Drug: BAY 1753011
    • Other: Placebo Furosemide
  • Active Comparator: Arm 1-B
    Furosemide 80mg in addition to Placebo BAY1753011 30mg for part B
    Interventions:
    • Other: Placebo BAY 1753011
    • Drug: Furosemide
  • Experimental: Arm 2-A
    BAY1753011 30mg in addition to Placebo Furosemide 80mg for part B
    Interventions:
    • Drug: BAY 1753011
    • Other: Placebo Furosemide
  • Active Comparator: Arm 2-B
    Furosemide 80mg in addition to Placebo BAY1753011 30mg for part B
    Interventions:
    • Other: Placebo BAY 1753011
    • Drug: Furosemide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 2, 2019)
414
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 21, 2020
Estimated Primary Completion Date June 16, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Bayer Clinical Trials Contact (+)1-888-84 22937 clinical-trials-contact@bayer.com
Listed Location Countries  ICMJE Austria,   Bulgaria,   Germany,   Greece,   Hungary,   Israel,   Italy,   Poland,   Portugal,   Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03901729
Other Study ID Numbers  ICMJE 17909
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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.

Responsible Party Bayer
Study Sponsor  ICMJE Bayer
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Bayer
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP