Trial Outcomes & Findings for The Effect of Vericiguat on Peripheral Vascular Function, Patient Health Status and Inflammation (NCT NCT05420012)
NCT ID: NCT05420012
Last Updated: 2025-10-08
Results Overview
Change in vascular function using flow-mediated vasodilation (FMD) test. FMD is quantified as the maximal change in brachial artery diameter following cuff release, expressed as a percentage increase from pre-occlusion values (%FMD).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
26 participants
Primary outcome timeframe
Baseline to 12 weeks
Results posted on
2025-10-08
Participant Flow
Participant milestones
| Measure |
Vericiguat
Study drug
Vericiguat: A starting dose of vericiguat 2.5 mg or matching placebo will be initiated after randomization and completion of the baseline testing. Subjects will be up-titrated in a blinded fashion to 5 mg and then to the target dose of 10 mg of vericiguat or matching placebo using titration criteria based on mean systolic blood pressure(SBP) evaluation and clinical symptoms at 2 week intervals. Titration to 10 mg in subjects who have not yet reached the target dose is intended at every visit/phone call throughout the study duration based on mean SBP measurement and safety considerations, at the discretion of the investigator.
|
Placebo
Placebo
Placebo: A starting dose of vericiguat 2.5 mg or matching placebo will be initiated after randomization and completion of the baseline testing. Subjects will be up-titrated in a blinded fashion to 5 mg and then to the target dose of 10 mg of vericiguat or matching placebo using titration criteria based on mean systolic blood pressure(SBP) evaluation and clinical symptoms at 2 week intervals. Titration to 10 mg in subjects who have not yet reached the target dose is intended at every visit/phone call throughout the study duration based on mean SBP measurement and safety considerations, at the discretion of the investigator.
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
13
|
|
Overall Study
COMPLETED
|
13
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Vericiguat
Study drug
Vericiguat: A starting dose of vericiguat 2.5 mg or matching placebo will be initiated after randomization and completion of the baseline testing. Subjects will be up-titrated in a blinded fashion to 5 mg and then to the target dose of 10 mg of vericiguat or matching placebo using titration criteria based on mean systolic blood pressure(SBP) evaluation and clinical symptoms at 2 week intervals. Titration to 10 mg in subjects who have not yet reached the target dose is intended at every visit/phone call throughout the study duration based on mean SBP measurement and safety considerations, at the discretion of the investigator.
|
Placebo
Placebo
Placebo: A starting dose of vericiguat 2.5 mg or matching placebo will be initiated after randomization and completion of the baseline testing. Subjects will be up-titrated in a blinded fashion to 5 mg and then to the target dose of 10 mg of vericiguat or matching placebo using titration criteria based on mean systolic blood pressure(SBP) evaluation and clinical symptoms at 2 week intervals. Titration to 10 mg in subjects who have not yet reached the target dose is intended at every visit/phone call throughout the study duration based on mean SBP measurement and safety considerations, at the discretion of the investigator.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
The Effect of Vericiguat on Peripheral Vascular Function, Patient Health Status and Inflammation
Baseline characteristics by cohort
| Measure |
Vericiguat
n=13 Participants
Study drug
Vericiguat: A starting dose of vericiguat 2.5 mg or matching placebo will be initiated after randomization and completion of the baseline testing. Subjects will be up-titrated in a blinded fashion to 5 mg and then to the target dose of 10 mg of vericiguat or matching placebo using titration criteria based on mean systolic blood pressure(SBP) evaluation and clinical symptoms at 2 week intervals. Titration to 10 mg in subjects who have not yet reached the target dose is intended at every visit/phone call throughout the study duration based on mean SBP measurement and safety considerations, at the discretion of the investigator.
|
Placebo
n=12 Participants
Placebo
Placebo: A starting dose of vericiguat 2.5 mg or matching placebo will be initiated after randomization and completion of the baseline testing. Subjects will be up-titrated in a blinded fashion to 5 mg and then to the target dose of 10 mg of vericiguat or matching placebo using titration criteria based on mean systolic blood pressure(SBP) evaluation and clinical symptoms at 2 week intervals. Titration to 10 mg in subjects who have not yet reached the target dose is intended at every visit/phone call throughout the study duration based on mean SBP measurement and safety considerations, at the discretion of the investigator.
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68 years
n=5 Participants
|
67 years
n=7 Participants
|
67 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=5 Participants
|
12 participants
n=7 Participants
|
25 participants
n=5 Participants
|
|
New York Heart Association Class II
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
New York Heart Association Class III
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Systolic Blood Pressure (mmHg)
|
112 mmHg
n=5 Participants
|
99 mmHg
n=7 Participants
|
109 mmHg
n=5 Participants
|
|
Diastolic Blood Pressure (mmHg)
|
75 mmHg
n=5 Participants
|
70 mmHg
n=7 Participants
|
71 mmHg
n=5 Participants
|
|
Body Mass Index (Kg/m^2)
|
29.3 Kg/m^2
n=5 Participants
|
30.9 Kg/m^2
n=7 Participants
|
30.8 Kg/m^2
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 12 weeksChange in vascular function using flow-mediated vasodilation (FMD) test. FMD is quantified as the maximal change in brachial artery diameter following cuff release, expressed as a percentage increase from pre-occlusion values (%FMD).
Outcome measures
| Measure |
Vericiguat
n=13 Participants
Study drug
Vericiguat: A starting dose of vericiguat 2.5 mg or matching placebo will be initiated after randomization and completion of the baseline testing. Subjects will be up-titrated in a blinded fashion to 5 mg and then to the target dose of 10 mg of vericiguat or matching placebo using titration criteria based on mean systolic blood pressure(SBP) evaluation and clinical symptoms at 2 week intervals. Titration to 10 mg in subjects who have not yet reached the target dose is intended at every visit/phone call throughout the study duration based on mean SBP measurement and safety considerations, at the discretion of the investigator.
|
Placebo
n=12 Participants
Placebo
Placebo: A starting dose of vericiguat 2.5 mg or matching placebo will be initiated after randomization and completion of the baseline testing. Subjects will be up-titrated in a blinded fashion to 5 mg and then to the target dose of 10 mg of vericiguat or matching placebo using titration criteria based on mean systolic blood pressure(SBP) evaluation and clinical symptoms at 2 week intervals. Titration to 10 mg in subjects who have not yet reached the target dose is intended at every visit/phone call throughout the study duration based on mean SBP measurement and safety considerations, at the discretion of the investigator.
|
Placebo IL-6 <2.0 pg/mL
Placebo arm participants with IL-6 values \<2 pg/mL
|
Placebo IL-6 ≥2.0 pg/mL
Placebo arm participants with IL-6 values ≥2.0 pg/mL
|
|---|---|---|---|---|
|
Flow-Mediated Dilation (FMD)
Baseline
|
3.61 % increase from pre-occlusion value
Standard Deviation 2.36
|
3.66 % increase from pre-occlusion value
Standard Deviation 1.33
|
—
|
—
|
|
Flow-Mediated Dilation (FMD)
Week 12
|
4.22 % increase from pre-occlusion value
Standard Deviation 2.33
|
3.55 % increase from pre-occlusion value
Standard Deviation 2.72
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to 12 weeksOutcome measures
| Measure |
Vericiguat
n=13 Participants
Study drug
Vericiguat: A starting dose of vericiguat 2.5 mg or matching placebo will be initiated after randomization and completion of the baseline testing. Subjects will be up-titrated in a blinded fashion to 5 mg and then to the target dose of 10 mg of vericiguat or matching placebo using titration criteria based on mean systolic blood pressure(SBP) evaluation and clinical symptoms at 2 week intervals. Titration to 10 mg in subjects who have not yet reached the target dose is intended at every visit/phone call throughout the study duration based on mean SBP measurement and safety considerations, at the discretion of the investigator.
|
Placebo
n=12 Participants
Placebo
Placebo: A starting dose of vericiguat 2.5 mg or matching placebo will be initiated after randomization and completion of the baseline testing. Subjects will be up-titrated in a blinded fashion to 5 mg and then to the target dose of 10 mg of vericiguat or matching placebo using titration criteria based on mean systolic blood pressure(SBP) evaluation and clinical symptoms at 2 week intervals. Titration to 10 mg in subjects who have not yet reached the target dose is intended at every visit/phone call throughout the study duration based on mean SBP measurement and safety considerations, at the discretion of the investigator.
|
Placebo IL-6 <2.0 pg/mL
Placebo arm participants with IL-6 values \<2 pg/mL
|
Placebo IL-6 ≥2.0 pg/mL
Placebo arm participants with IL-6 values ≥2.0 pg/mL
|
|---|---|---|---|---|
|
Six-minute Walk Test (6MWT)
Baseline
|
390 meters
Standard Deviation 155
|
398 meters
Standard Deviation 103
|
—
|
—
|
|
Six-minute Walk Test (6MWT)
Week 12
|
388 meters
Standard Deviation 148
|
406 meters
Standard Deviation 97
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to 12 weeksChange in Kansas City Cardiomyopathy Questionnaire-12(KCCQ12.) It is a 12-item self-administered questionnaire developed to independently measure the patient's perception of their health status, which includes heart failure symptoms, impact on physical and social function, and how their heart failure impacts their quality of life. Kansas City Cardiomyopathy Questionnaire-12(KCCQ-12) score is a 0-100 point scale with 0 being the worst status and 100 being the best possible status.
Outcome measures
| Measure |
Vericiguat
n=13 Participants
Study drug
Vericiguat: A starting dose of vericiguat 2.5 mg or matching placebo will be initiated after randomization and completion of the baseline testing. Subjects will be up-titrated in a blinded fashion to 5 mg and then to the target dose of 10 mg of vericiguat or matching placebo using titration criteria based on mean systolic blood pressure(SBP) evaluation and clinical symptoms at 2 week intervals. Titration to 10 mg in subjects who have not yet reached the target dose is intended at every visit/phone call throughout the study duration based on mean SBP measurement and safety considerations, at the discretion of the investigator.
|
Placebo
n=12 Participants
Placebo
Placebo: A starting dose of vericiguat 2.5 mg or matching placebo will be initiated after randomization and completion of the baseline testing. Subjects will be up-titrated in a blinded fashion to 5 mg and then to the target dose of 10 mg of vericiguat or matching placebo using titration criteria based on mean systolic blood pressure(SBP) evaluation and clinical symptoms at 2 week intervals. Titration to 10 mg in subjects who have not yet reached the target dose is intended at every visit/phone call throughout the study duration based on mean SBP measurement and safety considerations, at the discretion of the investigator.
|
Placebo IL-6 <2.0 pg/mL
Placebo arm participants with IL-6 values \<2 pg/mL
|
Placebo IL-6 ≥2.0 pg/mL
Placebo arm participants with IL-6 values ≥2.0 pg/mL
|
|---|---|---|---|---|
|
Kansas City Cardiomyopathy Questionnaire-12(KCCQ12)
Baseline
|
63 score on a scale
Standard Deviation 22
|
59 score on a scale
Standard Deviation 20
|
—
|
—
|
|
Kansas City Cardiomyopathy Questionnaire-12(KCCQ12)
Week 12
|
68 score on a scale
Standard Deviation 24
|
66 score on a scale
Standard Deviation 23
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksChange in Visual Analogue Scale (VAS). Patient self-rated health status on a 0-100 point scale with endpoints labeled 'the best health you can imagine'(100) and the 'worst health you can imagine' (0).
Outcome measures
| Measure |
Vericiguat
n=13 Participants
Study drug
Vericiguat: A starting dose of vericiguat 2.5 mg or matching placebo will be initiated after randomization and completion of the baseline testing. Subjects will be up-titrated in a blinded fashion to 5 mg and then to the target dose of 10 mg of vericiguat or matching placebo using titration criteria based on mean systolic blood pressure(SBP) evaluation and clinical symptoms at 2 week intervals. Titration to 10 mg in subjects who have not yet reached the target dose is intended at every visit/phone call throughout the study duration based on mean SBP measurement and safety considerations, at the discretion of the investigator.
|
Placebo
n=12 Participants
Placebo
Placebo: A starting dose of vericiguat 2.5 mg or matching placebo will be initiated after randomization and completion of the baseline testing. Subjects will be up-titrated in a blinded fashion to 5 mg and then to the target dose of 10 mg of vericiguat or matching placebo using titration criteria based on mean systolic blood pressure(SBP) evaluation and clinical symptoms at 2 week intervals. Titration to 10 mg in subjects who have not yet reached the target dose is intended at every visit/phone call throughout the study duration based on mean SBP measurement and safety considerations, at the discretion of the investigator.
|
Placebo IL-6 <2.0 pg/mL
Placebo arm participants with IL-6 values \<2 pg/mL
|
Placebo IL-6 ≥2.0 pg/mL
Placebo arm participants with IL-6 values ≥2.0 pg/mL
|
|---|---|---|---|---|
|
Visual Analogue Scale (VAS)
Week 12
|
70 score on a scale
Standard Deviation 20
|
72 score on a scale
Standard Deviation 13
|
—
|
—
|
|
Visual Analogue Scale (VAS)
Baseline
|
55 score on a scale
Standard Deviation 23
|
66 score on a scale
Standard Deviation 21
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksInflammation will be assessed by serum Interleukin-18 (IL-18) levels
Outcome measures
| Measure |
Vericiguat
n=13 Participants
Study drug
Vericiguat: A starting dose of vericiguat 2.5 mg or matching placebo will be initiated after randomization and completion of the baseline testing. Subjects will be up-titrated in a blinded fashion to 5 mg and then to the target dose of 10 mg of vericiguat or matching placebo using titration criteria based on mean systolic blood pressure(SBP) evaluation and clinical symptoms at 2 week intervals. Titration to 10 mg in subjects who have not yet reached the target dose is intended at every visit/phone call throughout the study duration based on mean SBP measurement and safety considerations, at the discretion of the investigator.
|
Placebo
n=12 Participants
Placebo
Placebo: A starting dose of vericiguat 2.5 mg or matching placebo will be initiated after randomization and completion of the baseline testing. Subjects will be up-titrated in a blinded fashion to 5 mg and then to the target dose of 10 mg of vericiguat or matching placebo using titration criteria based on mean systolic blood pressure(SBP) evaluation and clinical symptoms at 2 week intervals. Titration to 10 mg in subjects who have not yet reached the target dose is intended at every visit/phone call throughout the study duration based on mean SBP measurement and safety considerations, at the discretion of the investigator.
|
Placebo IL-6 <2.0 pg/mL
Placebo arm participants with IL-6 values \<2 pg/mL
|
Placebo IL-6 ≥2.0 pg/mL
Placebo arm participants with IL-6 values ≥2.0 pg/mL
|
|---|---|---|---|---|
|
Inflammatory Biomarkers Serum Interleukin-18 (IL-18)
Baseline
|
477 pg/mL
Standard Deviation 275
|
339 pg/mL
Standard Deviation 193
|
—
|
—
|
|
Inflammatory Biomarkers Serum Interleukin-18 (IL-18)
Week 12
|
461 pg/mL
Standard Deviation 312
|
334 pg/mL
Standard Deviation 205
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: At week 12, one sample in the vericiguat group could not be processed due to sample quality.
Inflammation will be assessed by serum Interleukin-6 (IL-6) levels
Outcome measures
| Measure |
Vericiguat
n=13 Participants
Study drug
Vericiguat: A starting dose of vericiguat 2.5 mg or matching placebo will be initiated after randomization and completion of the baseline testing. Subjects will be up-titrated in a blinded fashion to 5 mg and then to the target dose of 10 mg of vericiguat or matching placebo using titration criteria based on mean systolic blood pressure(SBP) evaluation and clinical symptoms at 2 week intervals. Titration to 10 mg in subjects who have not yet reached the target dose is intended at every visit/phone call throughout the study duration based on mean SBP measurement and safety considerations, at the discretion of the investigator.
|
Placebo
n=13 Participants
Placebo
Placebo: A starting dose of vericiguat 2.5 mg or matching placebo will be initiated after randomization and completion of the baseline testing. Subjects will be up-titrated in a blinded fashion to 5 mg and then to the target dose of 10 mg of vericiguat or matching placebo using titration criteria based on mean systolic blood pressure(SBP) evaluation and clinical symptoms at 2 week intervals. Titration to 10 mg in subjects who have not yet reached the target dose is intended at every visit/phone call throughout the study duration based on mean SBP measurement and safety considerations, at the discretion of the investigator.
|
Placebo IL-6 <2.0 pg/mL
n=12 Participants
Placebo arm participants with IL-6 values \<2 pg/mL
|
Placebo IL-6 ≥2.0 pg/mL
n=12 Participants
Placebo arm participants with IL-6 values ≥2.0 pg/mL
|
|---|---|---|---|---|
|
Inflammatory Biomarkers Serum Interleukin-6 (IL-6)
Baseline
|
9 Participants
|
4 Participants
|
11 Participants
|
1 Participants
|
|
Inflammatory Biomarkers Serum Interleukin-6 (IL-6)
Week 12
|
8 Participants
|
4 Participants
|
9 Participants
|
3 Participants
|
Adverse Events
Vericiguat
Serious events: 3 serious events
Other events: 5 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Vericiguat
n=13 participants at risk
Study drug
Vericiguat: A starting dose of vericiguat 2.5 mg or matching placebo will be initiated after randomization and completion of the baseline testing. Subjects will be up-titrated in a blinded fashion to 5 mg and then to the target dose of 10 mg of vericiguat or matching placebo using titration criteria based on mean systolic blood pressure(SBP) evaluation and clinical symptoms at 2 week intervals. Titration to 10 mg in subjects who have not yet reached the target dose is intended at every visit/phone call throughout the study duration based on mean SBP measurement and safety considerations, at the discretion of the investigator.
|
Placebo
n=12 participants at risk
Placebo
Placebo: A starting dose of vericiguat 2.5 mg or matching placebo will be initiated after randomization and completion of the baseline testing. Subjects will be up-titrated in a blinded fashion to 5 mg and then to the target dose of 10 mg of vericiguat or matching placebo using titration criteria based on mean systolic blood pressure(SBP) evaluation and clinical symptoms at 2 week intervals. Titration to 10 mg in subjects who have not yet reached the target dose is intended at every visit/phone call throughout the study duration based on mean SBP measurement and safety considerations, at the discretion of the investigator.
|
|---|---|---|
|
Cardiac disorders
Hospitalization
|
23.1%
3/13 • Number of events 3 • Baseline to Week 12
|
8.3%
1/12 • Number of events 1 • Baseline to Week 12
|
Other adverse events
| Measure |
Vericiguat
n=13 participants at risk
Study drug
Vericiguat: A starting dose of vericiguat 2.5 mg or matching placebo will be initiated after randomization and completion of the baseline testing. Subjects will be up-titrated in a blinded fashion to 5 mg and then to the target dose of 10 mg of vericiguat or matching placebo using titration criteria based on mean systolic blood pressure(SBP) evaluation and clinical symptoms at 2 week intervals. Titration to 10 mg in subjects who have not yet reached the target dose is intended at every visit/phone call throughout the study duration based on mean SBP measurement and safety considerations, at the discretion of the investigator.
|
Placebo
n=12 participants at risk
Placebo
Placebo: A starting dose of vericiguat 2.5 mg or matching placebo will be initiated after randomization and completion of the baseline testing. Subjects will be up-titrated in a blinded fashion to 5 mg and then to the target dose of 10 mg of vericiguat or matching placebo using titration criteria based on mean systolic blood pressure(SBP) evaluation and clinical symptoms at 2 week intervals. Titration to 10 mg in subjects who have not yet reached the target dose is intended at every visit/phone call throughout the study duration based on mean SBP measurement and safety considerations, at the discretion of the investigator.
|
|---|---|---|
|
Vascular disorders
Hypotension
|
7.7%
1/13 • Number of events 1 • Baseline to Week 12
|
8.3%
1/12 • Number of events 1 • Baseline to Week 12
|
|
General disorders
Headache
|
0.00%
0/13 • Baseline to Week 12
|
8.3%
1/12 • Number of events 1 • Baseline to Week 12
|
|
General disorders
Dizziness
|
38.5%
5/13 • Number of events 5 • Baseline to Week 12
|
50.0%
6/12 • Number of events 6 • Baseline to Week 12
|
|
General disorders
Fatigue
|
23.1%
3/13 • Number of events 3 • Baseline to Week 12
|
25.0%
3/12 • Number of events 3 • Baseline to Week 12
|
|
Blood and lymphatic system disorders
New onset anemia
|
7.7%
1/13 • Number of events 1 • Baseline to Week 12
|
0.00%
0/12 • Baseline to Week 12
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place