| 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. | | Posted | | Mean | Standard Deviation | mm Hg | | during repeat exercise run, approximately 30 minutes after study drug administration | | | | ID | Title | Description |
|---|
| OG000 | Nitrite | Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure. | | OG001 | Placebo | Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure. |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG00019.0± 5.0
- OG00128.0± 6.0
|
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | ANCOVA | | 0.0003 | | | | | | 2-Sided | | | | | | | No | Superiority or Other | | |
|
| Secondary | Change in Central Pressures After Study Drug (Resting) | Values are resting values after receiving study drug minus resting values before study drug (on the same day.) | | Posted | | Mean | Standard Deviation | mm Hg | | baseline, approximately 30 minutes after study drug administration | | | | ID | Title | Description |
|---|
| OG000 | Nitrite | Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure. | | OG001 | Placebo | Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure. |
| |
| Secondary | Change in Heart Rate After Study Drug (Resting) | Values are resting values after receiving study drug minus resting values before study drug (on the same day.) | | Posted | | Mean | Standard Deviation | beats/minute | | baseline, approximately 30 minutes after study drug administration | | | | ID | Title | Description |
|---|
| OG000 | Nitrite | Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure. | | OG001 | Placebo | Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure. |
| |
| Secondary | Change in Blood Pressure After Study Drug (Resting) | Values are resting values after receiving study drug minus resting values before study drug (on the same day.) | | Posted | | Mean | Standard Deviation | mm Hg | | baseline, approximately 30 minutes after study drug administration | | | | ID | Title | Description |
|---|
| OG000 | Nitrite | Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure. | | OG001 | Placebo | Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure. |
| |
| Secondary | Change in Pulmonary Vascular Resistance (PVR) After Study Drug (Resting) | Values are resting values after receiving study drug minus resting values before study drug (on the same day.) Pulmonary Vascular Resistance (PVR) is the resistance to flow that must be overcome to push blood through the pulmonary vasculature. Acute and chronic lung disease can both cause an increase in PVR. Chronic PVR can lead to right sided heart failure. | | Posted | | Mean | Standard Deviation | mm Hg/L/min | | baseline, approximately 30 minutes after study drug administration | | | | ID | Title | Description |
|---|
| OG000 | Nitrite | Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure. | | OG001 | Placebo | Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure. |
| |
| Secondary | Change in Pulmonary Artery (PA) Compliance After Study Drug (Resting) | Values are resting values after receiving study drug minus resting values before study drug (on the same day.) Pulmonary artery compliance is an index of the elasticity of the blood vessel, an indication of arterial stiffness. | | Posted | | Mean | Standard Deviation | ml/mm Hg | | baseline, approximately 30 minutes after study drug administration | | | | ID | Title | Description |
|---|
| OG000 | Nitrite | Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure. | | OG001 | Placebo | Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure. |
| |
| Secondary | Change in Systemic Vascular Resistance (SVR) After Study Drug (Resting) | Values are resting values after receiving study drug minus resting values before study drug (on the same day.) Systemic vascular resistance (SVR) refers to the resistance to blood flow offered by all of the systemic vasculature, excluding the pulmonary vasculature. | | Posted | | Mean | Standard Deviation | dyne/s * cm^5 | | baseline, approximately 30 minutes after study drug administration | | | | ID | Title | Description |
|---|
| OG000 | Nitrite | Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure. | | OG001 | Placebo | Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure. |
| |
| Secondary | Change in Left Ventricular Stroke Work (LVSW) After Study Drug (Resting) | Values are resting values after receiving study drug minus resting values before study drug (on the same day.) Stroke work refers to the work done by the ventricle to eject a volume of blood (i.e., stroke volume) into the aorta. Ventricular stroke work can be estimated as the product of stroke volume and mean aortic pressure during ejection. | | Posted | | Mean | Standard Deviation | g/beat | | baseline, approximately 30 minutes after study drug administration | | | | ID | Title | Description |
|---|
| OG000 | Nitrite | Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure. | | OG001 | Placebo | Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure. |
| |
| Secondary | Change in Oxygen Consumption (VO_2) After Study Drug (Resting) | Values are resting values after receiving study drug minus resting values before study drug (on the same day.) | | Posted | | Mean | Standard Deviation | ml/min | | baseline, approximately 30 minutes after study drug administration | | | | ID | Title | Description |
|---|
| OG000 | Nitrite | Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure. | | OG001 | Placebo | Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure. |
| |
| Secondary | Change in Arteriovenous Oxygen Content Difference After Study Drug (Resting) | Values are resting values after receiving study drug minus resting values before study drug (on the same day.) Arteriovenous oxygen difference is the difference in the oxygen content of the blood between the arterial blood and the venous blood. It is an indication of how much oxygen is removed from the blood in capillaries as the blood circulates in the body. | | Posted | | Mean | Standard Deviation | ml/dl | | baseline, approximately 30 minutes after study drug administration | | | | ID | Title | Description |
|---|
| OG000 | Nitrite | Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure. | | OG001 | Placebo | Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure. |
| |
| Secondary | Change in Cardiac Output After Study Drug (Resting) | Values are resting values after receiving study drug minus resting values before study drug (on the same day.) The volume of blood pumped per minute by each ventricle of the heart. Cardiac output is equal to the stroke volume (the amount of blood pumped from a ventricle in a single heartbeat) times the heart rate. | | Posted | | Mean | Standard Deviation | L/min | | baseline, approximately 30 minutes after study drug administration | | | | ID | Title | Description |
|---|
| OG000 | Nitrite | Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure. | | OG001 | Placebo | Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure. |
| |
| Secondary | Change in Stroke Volume After Study Drug (Resting) | Values are resting values after receiving study drug minus resting values before study drug (on the same day.) Stroke volume is the amount of blood pumped out of the heart (left ventricle - to the body) during each contraction. | | Posted | | Mean | Standard Deviation | ml | | baseline, approximately 30 minutes after study drug administration | | | | ID | Title | Description |
|---|
| OG000 | Nitrite | Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure. | | OG001 | Placebo | Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure. |
| |
| Secondary | Change in Central Pressures After Study Drug (Exercise) | Values are exercise values after receiving study drug minus exercise values before study drug (on the same day.) | | Posted | | Mean | Standard Deviation | mm Hg | | baseline, approximately 30 minutes after study drug administration | | | | ID | Title | Description |
|---|
| OG000 | Nitrite | Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure. | | OG001 | Placebo | Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure. |
| |
| Secondary | Change in Heart Rate After Study Drug (Exercise) | Values are exercise values after receiving study drug minus exercise values before study drug (on the same day.) | | Posted | | Mean | Standard Deviation | beats/minute | | baseline, approximately 30 minutes after study drug administration | | | | ID | Title | Description |
|---|
| OG000 | Nitrite | Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure. | | OG001 | Placebo | Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure. |
| |
| Secondary | Change in Blood Pressure After Study Drug (Exercise) | Values are exercise values after receiving study drug minus exercise values before study drug (on the same day.) | | Posted | | Mean | Standard Deviation | mm Hg | | baseline, approximately 30 minutes after study drug administration | | | | ID | Title | Description |
|---|
| OG000 | Nitrite | Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure. | | OG001 | Placebo | Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure. |
| |
| Secondary | Change in PVR After Study Drug (Exercise) | Values are exercise values after receiving study drug minus exercise values before study drug (on the same day.) Pulmonary Vascular Resistance (PVR) is the resistance to flow that must be overcome to push blood through the pulmonary vasculature. Acute and chronic lung disease can both cause an increase in PVR. Chronic PVR can lead to right sided heart failure. | | Posted | | Mean | Standard Deviation | mm Hg/L/min | | baseline, approximately 30 minutes after study drug administration | | | | ID | Title | Description |
|---|
| OG000 | Nitrite | Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure. | | OG001 | Placebo | Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure. |
| |
| Secondary | Change in PA Compliance After Study Drug (Exercise) | Values are exercise values after receiving study drug minus exercise values before study drug (on the same day.) Pulmonary artery compliance is an index of the elasticity of the blood vessel, an indication of arterial stiffness. | | Posted | | Mean | Standard Deviation | ml/mm Hg | | baseline, approximately 30 minutes after study drug administration | | | | ID | Title | Description |
|---|
| OG000 | Nitrite | Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure. | | OG001 | Placebo | Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure. |
| |
| Secondary | Change in SVR After Study Drug (Exercise) | Values are exercise values after receiving study drug minus exercise values before study drug (on the same day.) Systemic vascular resistance (SVR) refers to the resistance to blood flow offered by all of the systemic vasculature, excluding the pulmonary vasculature. | | Posted | | Mean | Standard Deviation | dyne/s * cm^5 | | baseline, approximately 30 minutes after study drug administration | | | | ID | Title | Description |
|---|
| OG000 | Nitrite | Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure. | | OG001 | Placebo | Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure. |
| |
| Secondary | Change in LVSW After Study Drug (Exercise) | Values are exercise values after receiving study drug minus exercise values before study drug (on the same day.) Stroke work refers to the work done by the ventricle to eject a volume of blood (i.e., stroke volume) into the aorta. Ventricular stroke work can be estimated as the product of stroke volume and mean aortic pressure during ejection. | | Posted | | Mean | Standard Deviation | g/beat | | baseline, approximately 30 minutes after study drug administration | | | | ID | Title | Description |
|---|
| OG000 | Nitrite | Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure. | | OG001 | Placebo | Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure. |
| |
| Secondary | Change in Oxygen Consumption (VO_2) After Study Drug (Exercise) | Values are exercise values after receiving study drug minus exercise values before study drug (on the same day.) | | Posted | | Mean | Standard Deviation | ml/min | | baseline, approximately 30 minutes after study drug administration | | | | ID | Title | Description |
|---|
| OG000 | Nitrite | Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure. | | OG001 | Placebo | Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure. |
| |
| Secondary | Change in Arteriovenous Oxygen Difference After Study Drug (Exercise) | Arteriovenous oxygen difference is the difference in the oxygen content of the blood between the arterial blood and the venous blood. It is an indication of how much oxygen is removed from the blood in capillaries as the blood circulates in the body. | | Posted | | Mean | Standard Deviation | ml/dl | | baseline, approximately 30 minutes after study drug administration | | | | ID | Title | Description |
|---|
| OG000 | Nitrite | Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure. | | OG001 | Placebo | Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure. |
| |
| Secondary | Change in Cardiac Output After Study Drug (Exercise) | Values are exercise values after receiving study drug minus exercise values before study drug (on the same day.) Cardiac output is equal to the stroke volume (the amount of blood pumped from a ventricle in a single heartbeat) times the heart rate. | | Posted | | Mean | Standard Deviation | L/min | | baseline, approximately 30 minutes after study drug administration | | | | ID | Title | Description |
|---|
| OG000 | Nitrite | Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure. | | OG001 | Placebo | Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure. |
| |
| Secondary | Change in Stroke Volume After Study Drug (Exercise) | Values are exercise values after receiving study drug minus exercise values before study drug (on the same day.) Stroke volume is the amount of blood pumped out of the heart (left ventricle - to the body) during each contraction. | | Posted | | Mean | Standard Deviation | ml | | baseline, approximately 30 minutes after study drug administration | | | | ID | Title | Description |
|---|
| OG000 | Nitrite | Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure. | | OG001 | Placebo | Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure. |
| |