Clinical trial

The Pathophysiological Role of Adrenergic Antibodies in Postural Tachycardia Syndrome (Aims #1&2)

Name
REB15-2434
Description
Objective: In this pilot study, we will test the hypothesis that patients with POTS (age 18-60 years) will have a higher percentage of functional antibodies to adrenergic receptors compared with control subjects without POTS.
Trial arms
Trial start
2016-01-01
Estimated PCD
2024-12-31
Trial end
2025-12-01
Status
Recruiting
Treatment
Phenylephrine
incremental small doses of IV phenylephrine to find the dose that transiently raises systolic blood pressure by 25 mmHg
Arms:
Healthy (control) Subjects, Postural Tachycardia Syndrome (POTS)
Other names:
NeoSynephrine
Isoproterenol
incremental small doses of IV isoproterenol to find the dose that transiently raises heart rate by 25 bpm
Arms:
Healthy (control) Subjects, Postural Tachycardia Syndrome (POTS)
Other names:
Isuprel
Size
125
Primary endpoint
The proportion of alpha-1 Ab titer positive subjects
1 Year (to measure Adrenergic antibody assay)
Eligibility criteria
Inclusion Criteria: * Patients who have been previously diagnosed with POTS * Control subjects (patients not diagnosed with POTS) * Age between 18 - 60 years * Males and Females (Give that \>80% of POTS patients are female, we will attempt to enroll a similar percentage of female control subjects) * Able and willing to provide consent Exclusion Criteria: * Smokers * Overt cause for postural tachycardia, i.e., acute dehydration * Significant cardiovascular, pulmonary, hepatic, or hematological disease by history or prior testing * Highly trained athletes * Subjects with somatization or severe anxiety symptoms will be excluded * Use of drospirenone (a spironolactone analogue) containing oral contraceptive agent * Hypertension defined as supine resting BP\>145/95 mmHg off medications or needing antihypertensive medication * Other factors which in the investigator's opinion would prevent the participant from completing the protocol, including poor compliance during previous studies or an unpredictable schedule * Unable to give informed consent
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'CASE_CONTROL', 'timePerspective': 'CROSS_SECTIONAL'}, 'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Serum for antibody assay; plasma for cytokine assessment; plasma for catecholamines'}, 'enrollmentInfo': {'count': 125, 'type': 'ESTIMATED'}}
Updated at
2024-05-08

1 organization

2 products

1 indication