Treatment of Orthostatic Intolerance

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 to 70 years
• All sexes
• Healthy volunteers accepted
• Adult, Older adult

Trial locations and contacts

1 site in 1 country.

About this study

Conditions

Tachycardia, Chronic Orthostatic Intolerance

Being tested

Acetazolamide, Atomoxetine, NO Drug, Clonidine, Entacapone

Keywords

tachycardia, sinus tachycardia, postural tachycardia syndrome (POTS)

Medical subject headings

Tachycardia, Tachycardia, Sinus, Postural Orthostatic Tachycardia Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• AcetazolamideDrug

  Also called Diamox

  250 mg PO x 1

• AtomoxetineDrug

  Also called Strattera

  10-40 mg PO x 1 dose

• NO DrugOther

  No intervention - just monitoring

• ClonidineDrug

  Also called Catapres

  Clonidine 0.05-0.3 mg PO x 1 dose

• EntacaponeDrug

  Also called Comtan

  Entacapone 200-400 mg PO x 1 dose

• Entacapone & PropranololDrug

  Also called Comtan, Inderal

  Entacapone 200-400 mg PO x 1 dose AND propranolol 20 mg PO x 1 dose

• Atomoxetine & PropranololDrug

  Also called Strattera, Inderal

  Atomoxetine 10-40 mg PO x 1 dose AND propranolol 20 mg PO x 1 dose

• IndomethacinDrug

  Also called Indocin

  Indomethacin 25-50 mg PO x 1 dose

• MecamylamineDrug

  Also called inversine

  mecamylamine 1.25-5 mg PO x 1 dose

• Isosorbide DinitrateDrug

  Also called Isordil

  Isosorbide dinitrate 5-20 mg PO x 1 dose

• MelatoninDietary supplement

  melatonin 3 mg PO x 1 dose

• MidodrineDrug

  Also called pro-amatine

  midodrine 2.5-10 mg PO x 1 dose

• ModafinilDrug

  Also called provigil

  modafinil 100-200 mg PO x 1 dose

• OctreotideDrug

  Also called sandostatin

  octreotide 12.5-50 mcg Subcutaneous x 1 dose

• PlaceboRadiation

  lactose tablet x 1 pill

• PropranololDrug

  Also called Inderal

  Propranolol 10-80 mg PO x 1-2 dose

• Modafinil & PropranololDrug

  Also called Provigil, Inderal

  Modafinil 100-200 mg PO x 1 dose AND Propranolol 20 mg PO x 1 dose

• SertralineDrug

  Also called Zoloft

  sertraline 25-50 mg PO x 1 dose

• IV SalineProcedure or surgery

  Also called NaCl solution (0.9%)

  1 liter IV over 2 hours

• Drinking WaterOther

  16 fluid ounces

• Breathing DeviceDevice

  Breathing through a dead space tube

• memantineDrug

  Also called Namenda

  memantine 5-20 mg PO x 1 dose

• Abdominal binderDevice

  Using large blood pressure cuffs linked together, they are wrapped around the subjects abdomen and inflated to generate increased pressure to below tolerably threshold.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Increase in heart rate with standing

   Measured: 1-4 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted6 Dec 2005 (estimated)
2. Study startApr 1997
3. Primary completionDec 2029 (estimated)
4. Study completionDec 2029 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Publications (8)Papers the sponsor has linked to this study.
• Other trials for TachycardiaStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.