A Phase 2 interventional study of BAY 1753011 and Placebo BAY 1753011 in Heart Failure (HF), sponsored by Bayer. Completed at 66 sites in 9 countries. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2022-04-18.
Sponsored by Bayer · Phase 2, Interventional, and Treatment
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.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's enrollment of 482 is above the median of 72 across 3,736 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.
Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.
Counted across the registry records on this site, refreshed daily.
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):
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
Exclusion Criteria
BAY1753011 30mg in addition to standard of care (SoC) for part A and part B
Drug: BAY 1753011
Placebo of BAY1753011 in addition to SoC for part A and part B
Other: Placebo BAY 1753011
BAY1753011 30mg in addition to Placebo Furosemide 80mg for part B
Drug: BAY 1753011 · Other: Placebo Furosemide
Furosemide 80mg in addition to Placebo BAY1753011 30mg for part B
Other: Placebo BAY 1753011 · Drug: Furosemide
BAY1753011 30mg in addition to Placebo Furosemide 80mg for part B
Drug: BAY 1753011 · Other: Placebo Furosemide
Furosemide 80mg in addition to Placebo BAY1753011 30mg for part B
Other: Placebo BAY 1753011 · Drug: Furosemide
Tablet; 30mg or 5mg unit; 30mg once daily in the morning; Oral
Tablet; Once daily in the morning; Oral
Tablet; 40mg unit; 80mg once daily in the morning; Oral
Tablet; Once daily in the morning; Oral
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 log transformed blood urea nitrogen (BUN)/creatinine ratio
Time frame: Compare Day 60 (End of part B) with Day 30 (Start of part B)
Incidence of Treatment-emergent adverse event (including Serious adverse event)
Time frame: From the time of first study drug administration up to 7 days after the last dose of study drug (Day 60)
Change in augmentation index
Time frame: Up to 60 days
Plan to share: 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.
This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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