Mechanisms of Vasovagal Syncope
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01791816|
Recruitment Status : Active, not recruiting
First Posted : February 15, 2013
Last Update Posted : July 16, 2019
|Condition or disease||Intervention/treatment||Phase|
|Vasovagal Syncope Postural Tachycardia Syndrome||Drug: Phenylephrine Drug: L-Ng-monomethyl Arginine (L-NMMA)||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Mechanisms of Vasovagal Syncope|
|Study Start Date :||February 2013|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
|Experimental: Phenylephrine and L-Ng-monomethyl Arginine (L-NMMA)||
Phenylephrine dose-response comprises infusion of 0.5, 1, 2, 3, 4 micrograms/kg/min for 10 min at each dose.
If bloods pressure increases by 30% or if heart rate decreases below 40 beats per minute we will stop infusion.
Drug: L-Ng-monomethyl Arginine (L-NMMA)
Systemic L-NMMA is infused as a 500μg/kg/min loading dose for 15 min followed by a 50μg/kg/min maintenance dose for the remainder of the experiment.
- Heart rate and blood pressure in response to Lower Body Negative Pressure(LBNP) [ Time Frame: 1 year ]
- Adrenergic neurotransmission as measured by Muscle Sympathetic Nerve Activity(MSNA), doppler ultrasound blood flow, venous Norepinephrine in response to Phenylephrine infusion [ Time Frame: 1 year ]
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): NCT01791816
|United States, New York|
|New York Medical College/Bradhurst Building|
|Hawthorne, New York, United States, 10532|
|Principal Investigator:||Julian M. Stewart, M.D., Ph.D.||New York Medical College|