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| ID | Type | Description | Link |
|---|---|---|---|
| UL1TR000135 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Advancing Translational Sciences (NCATS) | NIH |
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Researchers are studying the effect of a single dose of oral myeloperoxidase on heart failure versus placebo.
Enroll subjects with a normal ejection fraction referred to the catheterization laboratory for evaluation of breathlessness or shortness of breath. Perform safety lab sampling, echocardiography, arterial tonometry for pulse wave analysis, and assessment of endothelial function prior to administration of study drug. During the catheterization researchers will perform blood draws, assess baseline exercise capacity at rest and during exercise. Researchers will also do an echocardiogram to take measurements of the heart. Subjects will be randomized to one of two groups, Oral Myeloperoxidase Inhibitor or placebo group. Study drug or placebo will be administered followed by a repeat of the baseline catheterization assessments. At the conclusion of the second exercise test the subject will be moved to a room and monitored overnight for safety. Repeat blood draws, echocardiogram, endothelial function test, and heart monitoring will be completed. The subject will be asked to follow up with the researchers between 9-14 days after the study drug dosage. The subjects history and blood work will be completed at that visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AZD4831 Oral myeloperoxidase inhibitor | Experimental | Patient may take 30 mg of oral myeloperoxidase inhibitor following baseline right heart catheterization. |
|
| Placebo | Placebo Comparator | Patient may take 30 mg of placebo oral capsule following baseline right heart catheterization. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD4831 Oral Myeloperoxidase Inhibitor | Drug | A single administration dose of 30 mg oral MPO inhibitor given orally following baseline, resting and exercise testing in patients during right heart catheterization. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Exercise Pulmonary Capillary Wedge Pressure (PCWP) | 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. | Baseline, approximately 30 minutes after study drug administration |
| Exercise Pulmonary Capillary Wedge Pressure (PCWP) | 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. | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Resting Pulmonary Capillary Wedge Pressure (PCWP) | 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 while in resting state, measured in mmHg. | Baseline, approximately 30 minutes after study drug administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Barry A Borlaug, M.D. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | AZD4831 Oral Myeloperoxidase Inhibitor | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Exercise Pulmonary Capillary Wedge Pressure (PCWP) | 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. | Posted | Mean | Standard Deviation | mmHg | Baseline, approximately 30 minutes after study drug administration |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AZD4831 Oral Myeloperoxidase Inhibitor | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization for Heart Failure | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Barry A. Borlaug | Mayo Clinic | 507-255-2200 | borlaug.barry@mayo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 11, 2022 | Dec 17, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001519 | Behavior |
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Single Administration of study drug
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Only research pharmacy staff will be aware of randomization scheme and all study personnel and subjects will remain blinded.
|
| Placebo oral capsule | Drug | 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 | Exercise values after receiving study drug minus exercise values before study drug, obtained at 20 Watt workload, measured in mmHg. | Baseline, approximately 30 minutes after study drug administration |
| Change in Resting Central Pressures | Resting values after receiving study drug minus resting values before study drug, measured in mmHg. | Baseline, approximately 30 minutes after study drug administration |
| Change in Exercise Transmyocardial Lactate Ratio | Obtained 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. | Baseline, approximately 30 minutes after drug administration |
| Change in Resting Transmyocardial Lactate Ratio | Obtained 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. | Baseline, approximately 30 minutes after drug administration |
| BG001 |
| 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| 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. |
|
|
|
| Primary | Exercise Pulmonary Capillary Wedge Pressure (PCWP) | 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. | Posted | Mean | Standard Deviation | mmHg | Baseline |
|
|
|
| Secondary | Change in Resting Pulmonary Capillary Wedge Pressure (PCWP) | 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 while in resting state, measured in mmHg. | Posted | Mean | Standard Deviation | mmHg | Baseline, approximately 30 minutes after study drug administration |
|
|
|
|
| Secondary | Change in Exercise Central Pressures | Exercise values after receiving study drug minus exercise values before study drug, obtained at 20 Watt workload, measured in mmHg. | Posted | Mean | Standard Deviation | mmHg | Baseline, approximately 30 minutes after study drug administration |
|
|
|
|
| Secondary | Change in Resting Central Pressures | Resting values after receiving study drug minus resting values before study drug, measured in mmHg. | Posted | Mean | Standard Deviation | mmHg | Baseline, approximately 30 minutes after study drug administration |
|
|
|
|
| Secondary | Change in Exercise Transmyocardial Lactate Ratio | Obtained 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. | Posted | Mean | Standard Deviation | ratio | Baseline, approximately 30 minutes after drug administration |
|
|
|
|
| Secondary | Change in Resting Transmyocardial Lactate Ratio | Obtained 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. | Posted | Mean | Standard Deviation | ratio | Baseline, approximately 30 minutes after drug administration |
|
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 2 |
| 15 |
| EG001 | 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. | 0 | 15 | 1 | 15 | 0 | 15 |
| Vomiting | General disorders | Systematic Assessment |
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| Diarrhea | General disorders | Systematic Assessment |
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| Lower extremity deep vein thrombosis | General disorders | Systematic Assessment |
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| Mean pulmonary artery pressure |
|
| 0.148 |
| Superiority |
| Mean pulmonary artery pressure | t-test, 2 sided | 0.090 | Superiority |
| Mean pulmonary artery pressure |
|
| 0.796 |
| Superiority |
| Mean pulmonary artery pressure | t-test, 2 sided | 0.703 | Superiority |