Trial Outcomes & Findings for Myeloperoxidase (MPO) Inhibitor A_Zeneca for Heart Failure With Preserved Ejection Fraction (HFpEF) (NCT NCT03611153)
NCT ID: NCT03611153
Last Updated: 2025-01-08
Results Overview
Pulmonary capillary wedge pressure (PCWP) provides an indirect estimate of left atrial pressure (LAP). PCWP is the pressure measured by wedging a pulmonary catheter with an inflated balloon into a small pulmonary arterial branch. The exercise PCWP values are obtained at 20 Watt workload, measured in mmHg.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
30 participants
Primary outcome timeframe
Baseline, approximately 30 minutes after study drug administration
Results posted on
2025-01-08
Participant Flow
Participant milestones
| Measure |
AZD4831 Oral Myeloperoxidase Inhibitor
Patient may take 30 mg of oral myeloperoxidase inhibitor following baseline right heart catheterization.
AZD4831 Oral Myeloperoxidase(MPO) Inhibitor: A single administration dose of 30 mg oral MPO inhibitor given orally following baseline, resting and exercise testing in patients during right heart catheterization.
|
Placebo
Patient may take 30 mg of placebo oral capsule following baseline right heart catheterization.
Placebo oral capsule: A single administration dose of 30 mg placebo given orally following baseline, resting and exercise testing in patients during right heart catheterization.
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Myeloperoxidase (MPO) Inhibitor A_Zeneca for Heart Failure With Preserved Ejection Fraction (HFpEF)
Baseline characteristics by cohort
| Measure |
AZD4831 Oral Myeloperoxidase Inhibitor
n=15 Participants
Patient may take 30 mg of oral myeloperoxidase inhibitor following baseline right heart catheterization.
AZD4831 Oral Myeloperoxidase Inhibitor: A single administration dose of 30 mg oral MPO inhibitor given orally following baseline, resting and exercise testing in patients during right heart catheterization.
|
Placebo
n=15 Participants
Patient may take 30 mg of placebo oral capsule following baseline right heart catheterization.
Placebo oral capsule: A single administration dose of 30 mg placebo given orally following baseline, resting and exercise testing in patients during right heart catheterization.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70 years
STANDARD_DEVIATION 12 • n=99 Participants
|
70 years
STANDARD_DEVIATION 6 • n=107 Participants
|
70 years
STANDARD_DEVIATION 9 • n=206 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=99 Participants
|
15 participants
n=107 Participants
|
30 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline, approximately 30 minutes after study drug administrationPulmonary capillary wedge pressure (PCWP) provides an indirect estimate of left atrial pressure (LAP). PCWP is the pressure measured by wedging a pulmonary catheter with an inflated balloon into a small pulmonary arterial branch. The exercise PCWP values are obtained at 20 Watt workload, measured in mmHg.
Outcome measures
| Measure |
AZD4831 Oral Myeloperoxidase Inhibitor
n=15 Participants
Patient may take 30 mg of oral myeloperoxidase inhibitor following baseline right heart catheterization.
AZD4831 Oral Myeloperoxidase Inhibitor: A single administration dose of 30 mg oral MPO inhibitor given orally following baseline, resting and exercise testing in patients during right heart catheterization.
|
Placebo
n=15 Participants
Patient may take 30 mg of placebo oral capsule following baseline right heart catheterization.
Placebo oral capsule: A single administration dose of 30 mg placebo given orally following baseline, resting and exercise testing in patients during right heart catheterization.
|
|---|---|---|
|
Change in Exercise Pulmonary Capillary Wedge Pressure (PCWP)
|
-1 mmHg
Standard Deviation 3
|
-4 mmHg
Standard Deviation 5
|
PRIMARY outcome
Timeframe: BaselinePulmonary capillary wedge pressure (PCWP) provides an indirect estimate of left atrial pressure (LAP). PCWP is the pressure measured by wedging a pulmonary catheter with an inflated balloon into a small pulmonary arterial branch. The exercise PCWP values are obtained at 20 Watt workload, measured in mmHg.
Outcome measures
| Measure |
AZD4831 Oral Myeloperoxidase Inhibitor
n=15 Participants
Patient may take 30 mg of oral myeloperoxidase inhibitor following baseline right heart catheterization.
AZD4831 Oral Myeloperoxidase Inhibitor: A single administration dose of 30 mg oral MPO inhibitor given orally following baseline, resting and exercise testing in patients during right heart catheterization.
|
Placebo
n=15 Participants
Patient may take 30 mg of placebo oral capsule following baseline right heart catheterization.
Placebo oral capsule: A single administration dose of 30 mg placebo given orally following baseline, resting and exercise testing in patients during right heart catheterization.
|
|---|---|---|
|
Exercise Pulmonary Capillary Wedge Pressure (PCWP)
|
31 mmHg
Standard Deviation 6
|
32 mmHg
Standard Deviation 7
|
SECONDARY outcome
Timeframe: Baseline, approximately 30 minutes after study drug administrationPulmonary capillary wedge pressure (PCWP) provides an indirect estimate of left atrial pressure (LAP). PCWP is the pressure measured by wedging a pulmonary catheter with an inflated balloon into a small pulmonary arterial branch while in resting state, measured in mmHg.
Outcome measures
| Measure |
AZD4831 Oral Myeloperoxidase Inhibitor
n=15 Participants
Patient may take 30 mg of oral myeloperoxidase inhibitor following baseline right heart catheterization.
AZD4831 Oral Myeloperoxidase Inhibitor: A single administration dose of 30 mg oral MPO inhibitor given orally following baseline, resting and exercise testing in patients during right heart catheterization.
|
Placebo
n=15 Participants
Patient may take 30 mg of placebo oral capsule following baseline right heart catheterization.
Placebo oral capsule: A single administration dose of 30 mg placebo given orally following baseline, resting and exercise testing in patients during right heart catheterization.
|
|---|---|---|
|
Change in Resting Pulmonary Capillary Wedge Pressure (PCWP)
|
-2 mmHg
Standard Deviation 3
|
-2 mmHg
Standard Deviation 2
|
SECONDARY outcome
Timeframe: Baseline, approximately 30 minutes after study drug administrationExercise values after receiving study drug minus exercise values before study drug, obtained at 20 Watt workload, measured in mmHg.
Outcome measures
| Measure |
AZD4831 Oral Myeloperoxidase Inhibitor
n=15 Participants
Patient may take 30 mg of oral myeloperoxidase inhibitor following baseline right heart catheterization.
AZD4831 Oral Myeloperoxidase Inhibitor: A single administration dose of 30 mg oral MPO inhibitor given orally following baseline, resting and exercise testing in patients during right heart catheterization.
|
Placebo
n=15 Participants
Patient may take 30 mg of placebo oral capsule following baseline right heart catheterization.
Placebo oral capsule: A single administration dose of 30 mg placebo given orally following baseline, resting and exercise testing in patients during right heart catheterization.
|
|---|---|---|
|
Change in Exercise Central Pressures
Right atrial pressure
|
0 mmHg
Standard Deviation 3
|
0 mmHg
Standard Deviation 2
|
|
Change in Exercise Central Pressures
Pulmonary artery systolic pressure
|
-2 mmHg
Standard Deviation 5
|
-4 mmHg
Standard Deviation 5
|
|
Change in Exercise Central Pressures
Mean pulmonary artery pressure
|
-1 mmHg
Standard Deviation 4
|
-4 mmHg
Standard Deviation 5
|
SECONDARY outcome
Timeframe: Baseline, approximately 30 minutes after study drug administrationResting values after receiving study drug minus resting values before study drug, measured in mmHg.
Outcome measures
| Measure |
AZD4831 Oral Myeloperoxidase Inhibitor
n=15 Participants
Patient may take 30 mg of oral myeloperoxidase inhibitor following baseline right heart catheterization.
AZD4831 Oral Myeloperoxidase Inhibitor: A single administration dose of 30 mg oral MPO inhibitor given orally following baseline, resting and exercise testing in patients during right heart catheterization.
|
Placebo
n=15 Participants
Patient may take 30 mg of placebo oral capsule following baseline right heart catheterization.
Placebo oral capsule: A single administration dose of 30 mg placebo given orally following baseline, resting and exercise testing in patients during right heart catheterization.
|
|---|---|---|
|
Change in Resting Central Pressures
Right atrial pressure
|
0 mmHg
Standard Deviation 2
|
0 mmHg
Standard Deviation 1
|
|
Change in Resting Central Pressures
Pulmonary artery systolic pressure
|
-3 mmHg
Standard Deviation 5
|
-3 mmHg
Standard Deviation 5
|
|
Change in Resting Central Pressures
Mean pulmonary artery pressure
|
-1 mmHg
Standard Deviation 3
|
-2 mmHg
Standard Deviation 3
|
SECONDARY outcome
Timeframe: Baseline, approximately 30 minutes after drug administrationObtained at 20 Watt workload, determined by the lactate extraction ratio, which is calculated as lactate arterial minus lactate coronary sinus (CS) divided by lactate arterial. Negative values are indicative of myocardial ischemia.
Outcome measures
| Measure |
AZD4831 Oral Myeloperoxidase Inhibitor
n=15 Participants
Patient may take 30 mg of oral myeloperoxidase inhibitor following baseline right heart catheterization.
AZD4831 Oral Myeloperoxidase Inhibitor: A single administration dose of 30 mg oral MPO inhibitor given orally following baseline, resting and exercise testing in patients during right heart catheterization.
|
Placebo
n=15 Participants
Patient may take 30 mg of placebo oral capsule following baseline right heart catheterization.
Placebo oral capsule: A single administration dose of 30 mg placebo given orally following baseline, resting and exercise testing in patients during right heart catheterization.
|
|---|---|---|
|
Change in Exercise Transmyocardial Lactate Ratio
|
0.05 ratio
Standard Deviation 0.17
|
-0.01 ratio
Standard Deviation 0.15
|
SECONDARY outcome
Timeframe: Baseline, approximately 30 minutes after drug administrationObtained during resting state, determined by the lactate extraction ratio, which is calculated as lactate arterial minus lactate coronary sinus (CS) divided by lactate arterial. Negative values are indicative of myocardial ischemia.
Outcome measures
| Measure |
AZD4831 Oral Myeloperoxidase Inhibitor
n=15 Participants
Patient may take 30 mg of oral myeloperoxidase inhibitor following baseline right heart catheterization.
AZD4831 Oral Myeloperoxidase Inhibitor: A single administration dose of 30 mg oral MPO inhibitor given orally following baseline, resting and exercise testing in patients during right heart catheterization.
|
Placebo
n=15 Participants
Patient may take 30 mg of placebo oral capsule following baseline right heart catheterization.
Placebo oral capsule: A single administration dose of 30 mg placebo given orally following baseline, resting and exercise testing in patients during right heart catheterization.
|
|---|---|---|
|
Change in Resting Transmyocardial Lactate Ratio
|
0.16 ratio
Standard Deviation 0.49
|
0.10 ratio
Standard Deviation 0.23
|
Adverse Events
AZD4831 Oral Myeloperoxidase Inhibitor
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AZD4831 Oral Myeloperoxidase Inhibitor
n=15 participants at risk
Patient may take 30 mg of oral myeloperoxidase inhibitor following baseline right heart catheterization.
AZD4831 Oral Myeloperoxidase Inhibitor: A single administration dose of 30 mg oral MPO inhibitor given orally following baseline, resting and exercise testing in patients during right heart catheterization.
|
Placebo
n=15 participants at risk
Patient may take 30 mg of placebo oral capsule following baseline right heart catheterization.
Placebo oral capsule: A single administration dose of 30 mg placebo given orally following baseline, resting and exercise testing in patients during right heart catheterization.
|
|---|---|---|
|
Cardiac disorders
Hospitalization for Heart Failure
|
0.00%
0/15 • Adverse events were collected on each participant from the start of the invasive testing procedure and study drug administration, through the follow-up visit, which was approximately 9-14 days later; for a total of approximately 15 days.
|
6.7%
1/15 • Number of events 1 • Adverse events were collected on each participant from the start of the invasive testing procedure and study drug administration, through the follow-up visit, which was approximately 9-14 days later; for a total of approximately 15 days.
|
Other adverse events
| Measure |
AZD4831 Oral Myeloperoxidase Inhibitor
n=15 participants at risk
Patient may take 30 mg of oral myeloperoxidase inhibitor following baseline right heart catheterization.
AZD4831 Oral Myeloperoxidase Inhibitor: A single administration dose of 30 mg oral MPO inhibitor given orally following baseline, resting and exercise testing in patients during right heart catheterization.
|
Placebo
n=15 participants at risk
Patient may take 30 mg of placebo oral capsule following baseline right heart catheterization.
Placebo oral capsule: A single administration dose of 30 mg placebo given orally following baseline, resting and exercise testing in patients during right heart catheterization.
|
|---|---|---|
|
General disorders
Nausea
|
6.7%
1/15 • Number of events 1 • Adverse events were collected on each participant from the start of the invasive testing procedure and study drug administration, through the follow-up visit, which was approximately 9-14 days later; for a total of approximately 15 days.
|
0.00%
0/15 • Adverse events were collected on each participant from the start of the invasive testing procedure and study drug administration, through the follow-up visit, which was approximately 9-14 days later; for a total of approximately 15 days.
|
|
General disorders
Vomiting
|
6.7%
1/15 • Number of events 1 • Adverse events were collected on each participant from the start of the invasive testing procedure and study drug administration, through the follow-up visit, which was approximately 9-14 days later; for a total of approximately 15 days.
|
0.00%
0/15 • Adverse events were collected on each participant from the start of the invasive testing procedure and study drug administration, through the follow-up visit, which was approximately 9-14 days later; for a total of approximately 15 days.
|
|
General disorders
Diarrhea
|
6.7%
1/15 • Number of events 1 • Adverse events were collected on each participant from the start of the invasive testing procedure and study drug administration, through the follow-up visit, which was approximately 9-14 days later; for a total of approximately 15 days.
|
0.00%
0/15 • Adverse events were collected on each participant from the start of the invasive testing procedure and study drug administration, through the follow-up visit, which was approximately 9-14 days later; for a total of approximately 15 days.
|
|
General disorders
Lower extremity deep vein thrombosis
|
6.7%
1/15 • Number of events 1 • Adverse events were collected on each participant from the start of the invasive testing procedure and study drug administration, through the follow-up visit, which was approximately 9-14 days later; for a total of approximately 15 days.
|
0.00%
0/15 • Adverse events were collected on each participant from the start of the invasive testing procedure and study drug administration, through the follow-up visit, which was approximately 9-14 days later; for a total of approximately 15 days.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place