Trial Outcomes & Findings for A Study to Learn How Safe Starting Vericiguat at a Dose of 5 Milligrams is in Participants With Chronic Heart Failure With Reduced Ejection Fraction (NCT NCT06195930)
NCT ID: NCT06195930
Last Updated: 2025-09-25
Results Overview
Treatment tolerability, defined as the completion of the two-week 5 mg dose without discontinuation of study intervention (incl. max. 1 day interruption) and without moderate to severe symptomatic hypotension between Visit 1 and Visit 2
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
106 participants
Primary outcome timeframe
Between Visit 1 (Day 1) and Visit 2 (Day 14 up to Day 18 if +4 days time window is used)
Results posted on
2025-09-25
Participant Flow
Participant milestones
| Measure |
Vericiguat 5 mg
Participants who started with study intervention intake: Vericiguat 5 mg - At Visit 1, subjects received vericiguat (BAY1021189) 5 mg oral as tablet (on top of standard of care) with directions to take once daily for 14 days (up to 18 days: +4 day time window allowed).
|
|---|---|
|
Overall Study
STARTED
|
106
|
|
Overall Study
Participants With Worsening Heart Failure (HF)
|
53
|
|
Overall Study
Participants Without Worsening Heart Failure (HF)
|
53
|
|
Overall Study
COMPLETED
|
102
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Vericiguat 5 mg
Participants who started with study intervention intake: Vericiguat 5 mg - At Visit 1, subjects received vericiguat (BAY1021189) 5 mg oral as tablet (on top of standard of care) with directions to take once daily for 14 days (up to 18 days: +4 day time window allowed).
|
|---|---|
|
Overall Study
Adverse Event
|
4
|
Baseline Characteristics
A Study to Learn How Safe Starting Vericiguat at a Dose of 5 Milligrams is in Participants With Chronic Heart Failure With Reduced Ejection Fraction
Baseline characteristics by cohort
| Measure |
Vericiguat 5 mg
n=106 Participants
Participants who started with study intervention intake: Vericiguat 5 mg - At Visit 1, subjects received vericiguat (BAY1021189) 5 mg oral as tablet (on top of standard of care) with directions to take once daily for 14 days (up to 18 days: +4 day time window allowed).
|
|---|---|
|
Age, Continuous
|
66.9 Years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
|
Age, Customized
between 18 and 64 years
|
42 Participants
n=5 Participants
|
|
Age, Customized
from 65 to 84 years
|
61 Participants
n=5 Participants
|
|
Age, Customized
85 years and over
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
76 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
39 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
67 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
102 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
History of HF event
Participants with recent worsening HF event (Group 1)
|
53 Participants
n=5 Participants
|
|
History of HF event
Participants without recent worsening HF event (Group 2)
|
53 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Between Visit 1 (Day 1) and Visit 2 (Day 14 up to Day 18 if +4 days time window is used)Population: Safety Analysis Set (SAF) = 106 Participants
Treatment tolerability, defined as the completion of the two-week 5 mg dose without discontinuation of study intervention (incl. max. 1 day interruption) and without moderate to severe symptomatic hypotension between Visit 1 and Visit 2
Outcome measures
| Measure |
Vericiguat 5 mg
n=106 Participants
Participants who started with study intervention intake: Vericiguat 5 mg - At Visit 1, subjects received vericiguat (BAY1021189) 5 mg oral as tablet (on top of standard of care) with directions to take once daily for 14 days (up to 18 days: +4 day time window allowed).
|
|---|---|
|
Treatment Tolerability: Number of Participants Without Discontinuation of Study Intervention (Incl. Max. 1 Day Interruption) and Without Moderate to Severe Symptomatic Hypotension
|
99 Participants
|
PRIMARY outcome
Timeframe: Between Visit 1 (Day 1) and Visit 2 (Day 14 up to Day 18 if +4 days time window is used)Population: Safety Analysis Set (SAF) = 106 Participants
Treatment tolerability, defined as the completion of the two-week 5 mg dose without discontinuation of study intervention (incl. max. 2 day interruption) and without moderate to severe symptomatic hypotension between Visit 1 and Visit 2
Outcome measures
| Measure |
Vericiguat 5 mg
n=106 Participants
Participants who started with study intervention intake: Vericiguat 5 mg - At Visit 1, subjects received vericiguat (BAY1021189) 5 mg oral as tablet (on top of standard of care) with directions to take once daily for 14 days (up to 18 days: +4 day time window allowed).
|
|---|---|
|
Treatment Tolerability: Number of Participants Without Discontinuation of Study Intervention (Max. 2 Day Interruption Included) and Without Moderate to Severe Symptomatic Hypotension
|
102 Participants
|
SECONDARY outcome
Timeframe: Between Visit 1 (Day 1) and Visit 2 (Day 14 up to Day 18 if +4 days time window is used)Population: Safety Analysis Set (SAF) = 106 participants
Any AE reported between Visit 1 and Visit 2 to describe the safety events of initiation of 5mg dose.
Outcome measures
| Measure |
Vericiguat 5 mg
n=106 Participants
Participants who started with study intervention intake: Vericiguat 5 mg - At Visit 1, subjects received vericiguat (BAY1021189) 5 mg oral as tablet (on top of standard of care) with directions to take once daily for 14 days (up to 18 days: +4 day time window allowed).
|
|---|---|
|
Number of Participants With Any Adverse Event (AE) Reported Between Visit 1 and Visit 2
|
14 Participants
|
SECONDARY outcome
Timeframe: Between Visit 1 (Day 1) and Visit 2 (Day 14 up to Day 18 if +4 days time window is used)Population: Safety Analysis Set (SAF) = 106 participants
Absence of AEs related to study intervention between Visit 1 and Visit 2 to describe safety events of initiation of 5mg dose.
Outcome measures
| Measure |
Vericiguat 5 mg
n=106 Participants
Participants who started with study intervention intake: Vericiguat 5 mg - At Visit 1, subjects received vericiguat (BAY1021189) 5 mg oral as tablet (on top of standard of care) with directions to take once daily for 14 days (up to 18 days: +4 day time window allowed).
|
|---|---|
|
Number of Participants With no AE Related to Study Intervention Between Visit 1 and Visit 2
|
96 Participants
|
SECONDARY outcome
Timeframe: Between Visit 1 (Day 1) and Visit 2 (Day 14 up to Day 18 if +4 days time window is used)Population: Safety Analysis Set (SAF) = 106 Participants
To further evaluate the tolerability of 5mg as a starting dose
Outcome measures
| Measure |
Vericiguat 5 mg
n=106 Participants
Participants who started with study intervention intake: Vericiguat 5 mg - At Visit 1, subjects received vericiguat (BAY1021189) 5 mg oral as tablet (on top of standard of care) with directions to take once daily for 14 days (up to 18 days: +4 day time window allowed).
|
|---|---|
|
Number of Participants With Continuous Intake of Study Intervention Between Visit 1 and Visit 2 or Restart of Study Intervention After Any Temporary Interruption.
|
102 Participants
|
Adverse Events
Vericiguat 5 mg
Serious events: 1 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Vericiguat 5 mg
n=106 participants at risk
Participants who started with study intervention intake: Vericiguat 5 mg - At Visit 1, subjects received vericiguat (BAY1021189) 5 mg oral as tablet (on top of standard of care) with directions to take once daily for 14 days (up to 18 days: +4 day time window allowed).
|
|---|---|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.94%
1/106 • Number of events 1 • Between Visit 1 (Day 1) and Visit 2 (Day 14 up to Day 18 if +4 days time window is used)
|
Other adverse events
| Measure |
Vericiguat 5 mg
n=106 participants at risk
Participants who started with study intervention intake: Vericiguat 5 mg - At Visit 1, subjects received vericiguat (BAY1021189) 5 mg oral as tablet (on top of standard of care) with directions to take once daily for 14 days (up to 18 days: +4 day time window allowed).
|
|---|---|
|
Cardiac disorders
Cardiac failure
|
0.94%
1/106 • Number of events 1 • Between Visit 1 (Day 1) and Visit 2 (Day 14 up to Day 18 if +4 days time window is used)
|
|
Cardiac disorders
Cardiac failure congestive
|
0.94%
1/106 • Number of events 1 • Between Visit 1 (Day 1) and Visit 2 (Day 14 up to Day 18 if +4 days time window is used)
|
|
Gastrointestinal disorders
Dyspepsia
|
2.8%
3/106 • Number of events 3 • Between Visit 1 (Day 1) and Visit 2 (Day 14 up to Day 18 if +4 days time window is used)
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.94%
1/106 • Number of events 2 • Between Visit 1 (Day 1) and Visit 2 (Day 14 up to Day 18 if +4 days time window is used)
|
|
Infections and infestations
Gastroenteritis
|
0.94%
1/106 • Number of events 1 • Between Visit 1 (Day 1) and Visit 2 (Day 14 up to Day 18 if +4 days time window is used)
|
|
Nervous system disorders
Dizziness
|
0.94%
1/106 • Number of events 1 • Between Visit 1 (Day 1) and Visit 2 (Day 14 up to Day 18 if +4 days time window is used)
|
|
Nervous system disorders
Dysgeusia
|
0.94%
1/106 • Number of events 1 • Between Visit 1 (Day 1) and Visit 2 (Day 14 up to Day 18 if +4 days time window is used)
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.94%
1/106 • Number of events 1 • Between Visit 1 (Day 1) and Visit 2 (Day 14 up to Day 18 if +4 days time window is used)
|
|
Vascular disorders
Hypotension
|
6.6%
7/106 • Number of events 10 • Between Visit 1 (Day 1) and Visit 2 (Day 14 up to Day 18 if +4 days time window is used)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee CONSULTANT agrees that it will nit use the Confidential Information, which consultant is required hereunder to keep confidential, for any purposes other than the provision of services, without first entering into a written agreement signed by the consultant and Bayer covering the use thereof.
- Publication restrictions are in place
Restriction type: OTHER