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Trial record 3 of 15 for:    PKM

Effect of Digoxin on PKM2 Binding to Pro-inflammatory Loci and Innate Immune Inflammatory Responses in the Peripheral Blood.

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ClinicalTrials.gov Identifier: NCT03559868
Recruitment Status : Not yet recruiting
First Posted : June 18, 2018
Last Update Posted : June 18, 2018
Sponsor:
Information provided by (Responsible Party):
Yale University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Inflammatory Response Drug: Digoxin Other: placebo Phase 1

Detailed Description:

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 of how human peripheral blood immune cells change their inflammatory responses after exposure to digoxin in vitro.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Effect of Digoxin on PKM2 Binding to Pro-inflammatory Loci and Innate Immune Inflammatory Responses in the Peripheral Blood.
Estimated Study Start Date : February 1, 2019
Estimated Primary Completion Date : February 1, 2020
Estimated Study Completion Date : February 28, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Digoxin

Arm Intervention/treatment
Active Comparator: patients receiving digoxin 3mcg
Patients receiving digoxin 3 mcg/Kg/day
Drug: Digoxin
Different doses of digoxin to test if digoxin has an effect on the immune response of peripheral blood levels (PBLs).

Active Comparator: Patients receiving digoxin 0.3 mcg
Patients receiving digoxin 0.3 mcg/Kg/day
Drug: Digoxin
Different doses of digoxin to test if digoxin has an effect on the immune response of peripheral blood levels (PBLs).

Active Comparator: Patients receiving digoxin 0.15 mcg
Patients receiving digoxin 0.15 mcg/Kg/day
Drug: Digoxin
Different doses of digoxin to test if digoxin has an effect on the immune response of peripheral blood levels (PBLs).

Placebo Comparator: placebo
placebo
Other: placebo
placebo




Primary Outcome Measures :
  1. Lower levels of spontaneous reactive oxygen species (ROS) production [ Time Frame: after starting digoxin ]
    We will be taking 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. Lower levels of spontaneous reactive oxygen species (ROS) production [ Time Frame: 1 week after starting digoxin ]
    We will be taking 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.

  3. Lower levels of spontaneous reactive oxygen species (ROS) production [ Time Frame: 2 weeks after starting digoxin ]
    We will be taking 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.

  4. Lower levels of spontaneous reactive oxygen species (ROS) production [ Time Frame: 3 weeks after starting digoxin ]
    We will be taking 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.


Secondary Outcome Measures :
  1. Investigation of how human peripheral blood immune cells change their inflammatory responses after exposure to digoxin in vitro [ Time Frame: 6 weeks ]
    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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Ages between 18-75

Exclusion Criteria:

On any prescription medications.

  • Routinely taking over the counter medications.
  • Any abnormalities on electrocardiographs (ECG).
  • Any illness or vaccinations 3 months prior to enrollment or during study.
  • Active alcohol abuse (>50 g/day for men and >40 g/day for women) in the last 3 months.
  • Any liver disease.
  • Pregnancy.
  • Lack of signed informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03559868


Contacts
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Contact: Wajahat Mehal, MD 203-785-3411 wajahat.mehal@yale.edu
Contact: Muhammad Yousaf muhammad.yousaf@yale.edu

Sponsors and Collaborators
Yale University
Investigators
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Principal Investigator: Wajahat Mehal, MD Yale University

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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT03559868     History of Changes
Other Study ID Numbers: 2000023290
First Posted: June 18, 2018    Key Record Dates
Last Update Posted: June 18, 2018
Last Verified: June 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
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Digoxin
Anti-Arrhythmia Agents
Cardiotonic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs