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NCT00262470·Phase 1 / Phase 2·INTERVENTIONAL

Treatment of Orthostatic Intolerance

OctreotideOtherActive, not recruiting

Status

Active, not recruiting

Phase

Phase 1 / Phase 2

Enrollment

150

Locations

1

Results

Not posted

Publications

8

Study summary

What the protocol is testing.

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.

Full 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

Treatment arms and agents.

DRUG

Acetazolamide

250 mg PO x 1

DRUG

Atomoxetine

10-40 mg PO x 1 dose

OTHER

NO Drug

No intervention - just monitoring

DRUG

Clonidine

Clonidine 0.05-0.3 mg PO x 1 dose

DRUG

Entacapone

Entacapone 200-400 mg PO x 1 dose

DRUG

Entacapone & Propranolol

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

DRUG

Atomoxetine & Propranolol

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

DRUG

Indomethacin

Indomethacin 25-50 mg PO x 1 dose

DRUG

Mecamylamine

mecamylamine 1.25-5 mg PO x 1 dose

DRUG

Isosorbide Dinitrate

Isosorbide dinitrate 5-20 mg PO x 1 dose

DIETARY_SUPPLEMENT

Melatonin

melatonin 3 mg PO x 1 dose

DRUG

Midodrine

midodrine 2.5-10 mg PO x 1 dose

Timeline

From registration to results.

  1. First posted

    Dec 6, 2005

  2. Study start

    Apr 1997

  3. Primary completion

    Dec 2029

  4. Study completion

    Dec 2029

  5. Results posted

    Not reported

  6. Registry updated

    Oct 8, 2025

Outcomes

What the study measures.

Primary outcomes

Increase in heart rate with standing

Time frame · 1-4 hours

Secondary outcomes

Sitting heart rate

Time frame · 1-4 hours

Standing heart rate

Time frame · 1-4 hours

Blood pressure

Time frame · 1-4 hours

Decrease in blood pressure with standing

Time frame · 1-4 hours

Orthostatic symptoms score

Time frame · Baseline, 2h, 4h

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
70 Years
Sex
ALL
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

Study locations

1 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

Vanderbilt University Autonomic Dysfunction Center

Nashville, Tennessee, United States

Publications

Results and literature.

PMID 15911704 ↗Raj SR, Black BK, Biaggioni I, Harris PA, Robertson D. Acetylcholinesterase inhibition improves tachycardia in postural tachycardia syndrome. Circulation. 2005 May 31;111(21):2734-40. doi: 10.1161/CIRCULATIONAHA.104.497594. Epub 2005 May 23.PMID 19687359 ↗Raj SR, Black BK, Biaggioni I, Paranjape SY, Ramirez M, Dupont WD, Robertson D. Propranolol decreases tachycardia and improves symptoms in the postural tachycardia syndrome: less is more. Circulation. 2009 Sep 1;120(9):725-34. doi: 10.1161/CIRCULATIONAHA.108.846501. Epub 2009 Aug 17.PMID 32673517 ↗Smith EC, Diedrich A, Raj SR, Gamboa A, Shibao CA, Black BK, Peltier A, Paranjape SY, Biaggioni I, Okamoto LE. Splanchnic Venous Compression Enhances the Effects of ss-Blockade in the Treatment of Postural Tachycardia Syndrome. J Am Heart Assoc. 2020 Jul 21;9(14):e016196. doi: 10.1161/JAHA.120.016196. Epub 2020 Jul 16.PMID 24721800 ↗Nwazue VC, Paranjape SY, Black BK, Biaggioni I, Diedrich A, Dupont WD, Robertson D, Raj SR. Postural tachycardia syndrome and inappropriate sinus tachycardia: role of autonomic modulation and sinus node automaticity. J Am Heart Assoc. 2014 Apr 10;3(2):e000700. doi: 10.1161/JAHA.113.000700.PMID 24606242 ↗Nwazue VC, Arnold AC, Raj V, Black BK, Biaggioni I, Paranjape SY, Orozco C, Dupont WD, Robertson D, Raj SR. Understanding the placebo effect in clinical trials for postural tachycardia syndrome. Clin Exp Pharmacol Physiol. 2014 May;41(5):325-30. doi: 10.1111/1440-1681.12221.PMID 24495468 ↗Green EA, Black BK, Biaggioni I, Paranjape SY, Bagai K, Shibao C, Okoye MC, Dupont WD, Robertson D, Raj SR. Melatonin reduces tachycardia in postural tachycardia syndrome: a randomized, crossover trial. Cardiovasc Ther. 2014 Jun;32(3):105-12. doi: 10.1111/1755-5922.12067.PMID 24227635 ↗Mar PL, Raj V, Black BK, Biaggioni I, Shibao CA, Paranjape SY, Dupont WD, Robertson D, Raj SR. Acute hemodynamic effects of a selective serotonin reuptake inhibitor in postural tachycardia syndrome: a randomized, crossover trial. J Psychopharmacol. 2014 Feb;28(2):155-61. doi: 10.1177/0269881113512911. Epub 2013 Nov 13.PMID 24002370 ↗Green EA, Raj V, Shibao CA, Biaggioni I, Black BK, Dupont WD, Robertson D, Raj SR. Effects of norepinephrine reuptake inhibition on postural tachycardia syndrome. J Am Heart Assoc. 2013 Sep 3;2(5):e000395. doi: 10.1161/JAHA.113.000395.

Primary links

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ClinicalTrials.gov ↗Search PubMed ↗Search FDA ↗Search EMA ↗

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