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| ID | Type | Description | Link |
|---|---|---|---|
| 1U01AA026962-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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To investigate the effect of digoxin on pyruvate kinase isoform 2 (PKM2) binding to pro-inflammatory loci and innate immune inflammatory responses in the peripheral blood in healthy subjects.
To investigate the effect of orally administered digoxin on innate immune inflammatory responses in the peripheral blood of healthy subjects. We hypothesize the reduction in innate immune inflammatory responses will be expected in the peripheral blood with the effect of oral digoxin.
To investigation how human peripheral blood immune cells change their inflammatory responses after exposure to digoxin in vitro.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Digoxin 3 mcg/Kg/day | Active Comparator | Patients receiving oral digoxin 3 mcg/Kg/day |
|
| Digoxin 0.15 mcg | Active Comparator | Patients receiving oral digoxin 0.15 mcg/Kg/day |
|
| Placebo | Placebo Comparator | oral placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digoxin | Drug | Participants will receive 3 mcg/Kg/day doses of oral digoxin |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Lower Levels of Spontaneous Reactive Oxygen Species (ROS) Production | Investigators will be take neutrophils (PMN's) from the blood and seeing if the patients on digoxin have lower levels of spontaneous reactive oxygen species (ROS) production. This will be determined as a greater than 25% reduction in ROS compared to individuals not taking digoxin. The serum digoxin levels are just being done per usual guidelines to make sure that supratherapeutic levels of digoxin are not reached. | after starting digoxin |
| Lower Levels of Spontaneous Reactive Oxygen Species (ROS) Production | Investigators will take neutrophils (PMN's) from the blood and seeing if the patients on digoxin have lower levels of spontaneous reactive oxygen species (ROS) production. This will be determined as a greater than 25% reduction in ROS compared to individuals not taking digoxin. The serum digoxin levels are just being done per usual guidelines to make sure that supratherapeutic levels of digoxin are not reached. | 1 week after starting digoxin |
| Lower Levels of Spontaneous Reactive Oxygen Species (ROS) Production | Investigators will take neutrophils (PMN's) from the blood and seeing if the patients on digoxin have lower levels of spontaneous reactive oxygen species (ROS) production. This will be determined as a greater than 25% reduction in ROS compared to individuals not taking digoxin. The serum digoxin levels are just being done per usual guidelines to make sure that supratherapeutic levels of digoxin are not reached. | 2 weeks after starting digoxin |
| Lower Levels of Spontaneous Reactive Oxygen Species (ROS) Production | Investigators will take neutrophils (PMN's) from the blood and seeing if the patients on digoxin have lower levels of spontaneous reactive oxygen species (ROS) production. This will be determined as a greater than 25% reduction in ROS compared to individuals not taking digoxin. The serum digoxin levels are just being done per usual guidelines to make sure that supratherapeutic levels of digoxin are not reached. |
| Measure | Description | Time Frame |
|---|---|---|
| Investigation of How Human Peripheral Blood Immune Cells Change Their Inflammatory Responses After Exposure to Digoxin in Vitro | Blood (25ml) will be obtained from healthy blood donors at one time. Human peripheral monocytes will be isolated using Polymorphprep™ density sedimentation according to the manufacturer's instructions. Data presented here are the mean concentrations. | 6 weeks |
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Inclusion Criteria
Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Wajahat Mehal, MD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale Centre of Clinical Investigation | New Haven | Connecticut | 06520 | United States |
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3 participants were consented but never started.
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| ID | Title | Description |
|---|---|---|
| FG000 | Digoxin 3 mcg/Kg/Day | Patients receiving oral digoxin 3 mcg/Kg/day Digoxin: Participants will receive 3 mcg/Kg/day doses of oral digoxin |
| FG001 | Digoxin 0.15 mcg | Patients receiving oral digoxin 0.15 mcg/Kg/day Digoxin: Participants will receive 0.15 mcg/Kg/day doses of oral digoxin |
| FG002 | Placebo | oral placebo Placebo: Oral placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Baseline characteristics were only collected from completers.
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| ID | Title | Description |
|---|---|---|
| BG000 | Digoxin 3 mcg/Kg/Day | Patients receiving oral digoxin 3 mcg/Kg/day Digoxin: Participants will receive 3 mcg/Kg/day doses of oral digoxin |
| BG001 | Digoxin 0.15 mcg | Patients receiving oral digoxin 0.15 mcg/Kg/day Digoxin: Participants will receive 0.15 mcg/Kg/day doses of oral digoxin |
| 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 | Lower Levels of Spontaneous Reactive Oxygen Species (ROS) Production | Investigators will be take neutrophils (PMN's) from the blood and seeing if the patients on digoxin have lower levels of spontaneous reactive oxygen species (ROS) production. This will be determined as a greater than 25% reduction in ROS compared to individuals not taking digoxin. The serum digoxin levels are just being done per usual guidelines to make sure that supratherapeutic levels of digoxin are not reached. | No data for this outcome was collected. | Posted | after starting digoxin |
|
6 weeks
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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 | Digoxin 3 mcg/Kg/Day | Patients receiving oral digoxin 3 mcg/Kg/day Digoxin: Participants will receive 3 mcg/Kg/day doses of oral digoxin |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mehal Wajahat MD, DPhil | Yale University, Yale School of Medicine | 877.925.3637 | wajahat.mehal@yale.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 | Apr 19, 2023 | May 31, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 25, 2022 | Feb 13, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D004077 | Digoxin |
| ID | Term |
|---|---|
| D004071 | Digitalis Glycosides |
| D002298 | Cardenolides |
| D002301 | Cardiac Glycosides |
| D002297 | Cardanolides |
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| Placebo |
| Other |
Oral placebo |
|
| Digoxin | Drug | Participants will receive 0.15 mcg/Kg/day doses of oral digoxin |
|
| 3 weeks after starting digoxin |
| BG002 | Placebo | oral placebo Placebo: Oral placebo |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Patients receiving oral digoxin 0.15 mcg/Kg/day Digoxin: Participants will receive 0.15 mcg/Kg/day doses of oral digoxin |
| OG002 | Placebo | oral placebo Placebo: Oral placebo |
|
| Primary | Lower Levels of Spontaneous Reactive Oxygen Species (ROS) Production | Investigators will take neutrophils (PMN's) from the blood and seeing if the patients on digoxin have lower levels of spontaneous reactive oxygen species (ROS) production. This will be determined as a greater than 25% reduction in ROS compared to individuals not taking digoxin. The serum digoxin levels are just being done per usual guidelines to make sure that supratherapeutic levels of digoxin are not reached. | No data for this outcome was collected. | Posted | 1 week after starting digoxin |
|
|
| Primary | Lower Levels of Spontaneous Reactive Oxygen Species (ROS) Production | Investigators will take neutrophils (PMN's) from the blood and seeing if the patients on digoxin have lower levels of spontaneous reactive oxygen species (ROS) production. This will be determined as a greater than 25% reduction in ROS compared to individuals not taking digoxin. The serum digoxin levels are just being done per usual guidelines to make sure that supratherapeutic levels of digoxin are not reached. | No data for this outcome was collected. | Posted | 2 weeks after starting digoxin |
|
|
| Primary | Lower Levels of Spontaneous Reactive Oxygen Species (ROS) Production | Investigators will take neutrophils (PMN's) from the blood and seeing if the patients on digoxin have lower levels of spontaneous reactive oxygen species (ROS) production. This will be determined as a greater than 25% reduction in ROS compared to individuals not taking digoxin. The serum digoxin levels are just being done per usual guidelines to make sure that supratherapeutic levels of digoxin are not reached. | No data for this outcome was collected. | Posted | 3 weeks after starting digoxin |
|
|
| Secondary | Investigation of How Human Peripheral Blood Immune Cells Change Their Inflammatory Responses After Exposure to Digoxin in Vitro | Blood (25ml) will be obtained from healthy blood donors at one time. Human peripheral monocytes will be isolated using Polymorphprep™ density sedimentation according to the manufacturer's instructions. Data presented here are the mean concentrations. | Posted | Mean | Standard Deviation | pg/ml | 6 weeks |
|
|
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| 0 |
| 14 |
| EG001 | Digoxin 0.15 mcg | Patients receiving oral digoxin 0.15 mcg/Kg/day Digoxin: Participants will receive 0.15 mcg/Kg/day doses of oral digoxin | 0 | 14 | 0 | 14 | 0 | 14 |
| EG002 | Placebo | oral placebo Placebo: Oral placebo | 0 | 14 | 0 | 14 | 0 | 14 |
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| D013256 |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
|
| CCL20 |
|
| CXCL1 |
|
| CXCL10 |
|
| G-CSF |
|
| GM-CSF |
|
| Granzyme B |
|
| IFN Alpha |
|
| IFN Gamma |
|
| IL-RA |
|
| IL-6 |
|
| PDGF AA |
|
| PDGF AB/BB |
|
| TNF Alpha |
|
| IL-8 |
|
| Galactin 9 |
|
| IL10 |
|