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Treatment and Prognosis of Neurogenic Orthostatic Hypotension : A Prospective Randomized Study

NCT ID: NCT02308124

Last Updated: 2021-10-19

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

87 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2016-09-30

Brief Summary

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Compare the effect of treatment of midodrine and pyridostigmine in neurogenic orthostatic hypotension and investigate the quality of life of treatment of neurogenic orthostatic hypotension.

Detailed Description

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In patients with neurogenic orthostatic hypotension, the appropriate treatment was identified by comparing the treatment effects and side effects for each treatment drug. In addition, by confirming the effect of orthostatic hypotension on lowering the quality of life, it is expected that the improvement of the quality of life will help.

Conditions

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Orthostatic; Hypotension, Neurogenic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Midodrine

Start midodrine 2.5mg bid, and then dose up to 5mg bid after one month if necessary.

Group Type EXPERIMENTAL

Midodrine

Intervention Type DRUG

Pyridostigmine

Start Pyridostigmine 30mg bid, and then dose up to 60mg bid after one month if necessary.

Group Type EXPERIMENTAL

Pyridostigmine Bromide

Intervention Type DRUG

Midodrine + Pyridostigmine

Start midodrine 2.5mg bid+ Pyridostigmine 30mg bid, and then dose up to midodrine 5mg bid+ Pyridostigmine 60mg bid after one month if necessary.

Group Type EXPERIMENTAL

Midodrine + pyridostigmine

Intervention Type DRUG

Interventions

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Midodrine

Intervention Type DRUG

Pyridostigmine Bromide

Intervention Type DRUG

Midodrine + pyridostigmine

Intervention Type DRUG

Other Intervention Names

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Midodrine only Pyridostigmine only Combination

Eligibility Criteria

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Inclusion Criteria

* age \>=18 patients who complained of dizziness
* Orthostatic hypotension after 3-minute standing (systolic blood pressure drop \>=20 or diastolic blood pressure drop \>=10

Exclusion Criteria

* Drug-induced hypotension, if necessary, evaluate patient after discontinuing the causative drug for one month
* Heart failure or Chronic renal failure
* Patients who cannot or do not want to write questionaires.
* Poor drug compliance
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Kon Chu

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kon Chu

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital, Seoul, South Korea

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Arbique D, Cheek D, Welliver M, Vongpatanasin W. Management of neurogenic orthostatic hypotension. J Am Med Dir Assoc. 2014 Apr;15(4):234-9. doi: 10.1016/j.jamda.2013.10.014. Epub 2014 Jan 2.

Reference Type BACKGROUND
PMID: 24388946 (View on PubMed)

Smith ND. Orthostatic Hypotension in the Patient with Diabetes: A Broad Review of Pharmacologic Treatment Options. Journal of Pharmacy Technology. 2013 January 1, 2013;29(1):23-34.

Reference Type BACKGROUND

Low PA, Singer W. Management of neurogenic orthostatic hypotension: an update. Lancet Neurol. 2008 May;7(5):451-8. doi: 10.1016/S1474-4422(08)70088-7.

Reference Type BACKGROUND
PMID: 18420158 (View on PubMed)

Shibao C, Grijalva CG, Raj SR, Biaggioni I, Griffin MR. Orthostatic hypotension-related hospitalizations in the United States. Am J Med. 2007 Nov;120(11):975-80. doi: 10.1016/j.amjmed.2007.05.009.

Reference Type BACKGROUND
PMID: 17976425 (View on PubMed)

Goldstein DS, Sharabi Y. Neurogenic orthostatic hypotension: a pathophysiological approach. Circulation. 2009 Jan 6;119(1):139-46. doi: 10.1161/CIRCULATIONAHA.108.805887. No abstract available.

Reference Type BACKGROUND
PMID: 19124673 (View on PubMed)

Lahrmann H, Cortelli P, Hilz M, Mathias CJ, Struhal W, Tassinari M. EFNS guidelines on the diagnosis and management of orthostatic hypotension. Eur J Neurol. 2006 Sep;13(9):930-6. doi: 10.1111/j.1468-1331.2006.01512.x.

Reference Type BACKGROUND
PMID: 16930356 (View on PubMed)

Parsaik AK, Singh B, Altayar O, Mascarenhas SS, Singh SK, Erwin PJ, Murad MH. Midodrine for orthostatic hypotension: a systematic review and meta-analysis of clinical trials. J Gen Intern Med. 2013 Nov;28(11):1496-503. doi: 10.1007/s11606-013-2520-3. Epub 2013 Jun 18.

Reference Type BACKGROUND
PMID: 23775146 (View on PubMed)

Wright RA, Kaufmann HC, Perera R, Opfer-Gehrking TL, McElligott MA, Sheng KN, Low PA. A double-blind, dose-response study of midodrine in neurogenic orthostatic hypotension. Neurology. 1998 Jul;51(1):120-4. doi: 10.1212/wnl.51.1.120.

Reference Type BACKGROUND
PMID: 9674789 (View on PubMed)

Kaufmann H, Malamut R, Norcliffe-Kaufmann L, Rosa K, Freeman R. The Orthostatic Hypotension Questionnaire (OHQ): validation of a novel symptom assessment scale. Clin Auton Res. 2012 Apr;22(2):79-90. doi: 10.1007/s10286-011-0146-2. Epub 2011 Nov 2.

Reference Type BACKGROUND
PMID: 22045363 (View on PubMed)

Jankovic J, Gilden JL, Hiner BC, Kaufmann H, Brown DC, Coghlan CH, Rubin M, Fouad-Tarazi FM. Neurogenic orthostatic hypotension: a double-blind, placebo-controlled study with midodrine. Am J Med. 1993 Jul;95(1):38-48. doi: 10.1016/0002-9343(93)90230-m.

Reference Type BACKGROUND
PMID: 7687093 (View on PubMed)

Low PA, Gilden JL, Freeman R, Sheng KN, McElligott MA. Efficacy of midodrine vs placebo in neurogenic orthostatic hypotension. A randomized, double-blind multicenter study. Midodrine Study Group. JAMA. 1997 Apr 2;277(13):1046-51.

Reference Type BACKGROUND
PMID: 9091692 (View on PubMed)

Singer W, Opfer-Gehrking TL, McPhee BR, Hilz MJ, Bharucha AE, Low PA. Acetylcholinesterase inhibition: a novel approach in the treatment of neurogenic orthostatic hypotension. J Neurol Neurosurg Psychiatry. 2003 Sep;74(9):1294-8. doi: 10.1136/jnnp.74.9.1294.

Reference Type BACKGROUND
PMID: 12933939 (View on PubMed)

Singer W, Sandroni P, Opfer-Gehrking TL, Suarez GA, Klein CM, Hines S, O'Brien PC, Slezak J, Low PA. Pyridostigmine treatment trial in neurogenic orthostatic hypotension. Arch Neurol. 2006 Apr;63(4):513-8. doi: 10.1001/archneur.63.4.noc50340. Epub 2006 Feb 13.

Reference Type BACKGROUND
PMID: 16476804 (View on PubMed)

Byun JI, Moon J, Kim DY, Shin H, Sunwoo JS, Lim JA, Kim TJ, Lee WJ, Lee HS, Jun JS, Park KI, Lee ST, Jung KH, Jung KY, Lee SK, Chu K. Efficacy of single or combined midodrine and pyridostigmine in orthostatic hypotension. Neurology. 2017 Sep 5;89(10):1078-1086. doi: 10.1212/WNL.0000000000004340. Epub 2017 Aug 9.

Reference Type DERIVED
PMID: 28794253 (View on PubMed)

Other Identifiers

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1409066609

Identifier Type: -

Identifier Source: org_study_id