Tachycardia, Chronic Orthostatic Intolerance
Conditions
Keywords
tachycardia, sinus tachycardia, postural tachycardia syndrome (POTS)
Brief summary
This trial is designed to study the effects of various mechanistically unique medications in controlling excessive increases in heart rate with standing and in improving the symptoms of orthostatic intolerance in patients with this disorder.
Detailed description
This trial is designed to study the effects of various mechanistically unique medications in controlling excessive increases in heart rate with standing and in improving the symptoms of orthostatic intolerance in patients with this disorder. Pilot drug trials are 4h in duration from \ 9am -1pm. Different short-acting medications will be used to determine their acute hemodynamic effects in patients with orthostatic intolerance.
Interventions
DRUGAcetazolamide
250 mg PO x 1
DRUGAtomoxetine
10-40 mg PO x 1 dose
OTHERNO Drug
No intervention - just monitoring
DRUGClonidine
Clonidine 0.05-0.3 mg PO x 1 dose
DRUGEntacapone
Entacapone 200-400 mg PO x 1 dose
DRUGEntacapone & Propranolol
Entacapone 200-400 mg PO x 1 dose AND propranolol 20 mg PO x 1 dose
DRUGAtomoxetine & Propranolol
Atomoxetine 10-40 mg PO x 1 dose AND propranolol 20 mg PO x 1 dose
DRUGIndomethacin
Indomethacin 25-50 mg PO x 1 dose
DRUGMecamylamine
mecamylamine 1.25-5 mg PO x 1 dose
Isosorbide dinitrate 5-20 mg PO x 1 dose
DIETARY_SUPPLEMENTMelatonin
melatonin 3 mg PO x 1 dose
DRUGMidodrine
midodrine 2.5-10 mg PO x 1 dose
DRUGModafinil
modafinil 100-200 mg PO x 1 dose
DRUGOctreotide
octreotide 12.5-50 mcg Subcutaneous x 1 dose
RADIATIONPlacebo
lactose tablet x 1 pill
DRUGPropranolol
Propranolol 10-80 mg PO x 1-2 dose
DRUGModafinil & Propranolol
Modafinil 100-200 mg PO x 1 dose AND Propranolol 20 mg PO x 1 dose
DRUGSertraline
sertraline 25-50 mg PO x 1 dose
PROCEDUREIV Saline
1 liter IV over 2 hours
OTHERDrinking Water
16 fluid ounces
DEVICEBreathing Device
Breathing through a dead space tube
DRUGmemantine
memantine 5-20 mg PO x 1 dose
DEVICEAbdominal binder
Using large blood pressure cuffs linked together, they are wrapped around the subjects abdomen and inflated to generate increased pressure to below tolerably threshold.
Sponsors
National Center for Advancing Translational Sciences (NCATS)
Satish R. Raj
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Chronic symptoms (\> 6 months) with standing upright
Exclusion criteria
* Obvious cause of hypovolemia or drugs that could worsen tachycardia * Chronic severe medical conditions such as cancer or ischemic heart disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Increase in heart rate with standing | 1-4 hours |
Secondary
| Measure | Time frame |
|---|---|
| Sitting heart rate | 1-4 hours |
| Standing heart rate | 1-4 hours |
| Blood pressure | 1-4 hours |
| Decrease in blood pressure with standing | 1-4 hours |
| Orthostatic symptoms score | Baseline, 2h, 4h |
Countries
United States
Outcome results
None listed