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

NCT02308124 | Completed Phase 4 Results DMC

• 1 other identifier: 1409066609
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Orthostatic; Hypotension, Neurogenic

Outcome Measures

Primary Outcomes (1)

• Change in Orthostatic BP Drop

  Change of orthostatic SBP and DBP drop after 3-month medical treatment compared to initial results.

  after 3-month medical treatment

Secondary Outcomes (4)

• Change of the Orthostatic Hypotension Associated Symptom Questionnaire (OH Questionnaire (OHQ)).

  after 3-month medical treatment.

• Change of the Depression Score (Beck Depression Inventory-II )

  after 3-month medical treatment.

• Short-form 36 Version 2

  changes at 3 months after treatment

• Changes in Health-related Quality of Life

  changes at 3 months after treatment

Study Arms (3)

Midodrine

EXPERIMENTAL

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

Drug: Midodrine

Pyridostigmine

EXPERIMENTAL

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

Drug: Pyridostigmine Bromide

Midodrine + Pyridostigmine

EXPERIMENTAL

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

Drug: Midodrine + pyridostigmine

Interventions

Midodrine DRUG

Also known as: Midodrine only

Midodrine

Pyridostigmine Bromide DRUG

Also known as: Pyridostigmine only

Pyridostigmine

Midodrine + pyridostigmine DRUG

Also known as: Combination

Midodrine + Pyridostigmine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

Related Publications (14)

• 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.

  PMID: 24388946 BACKGROUND

• 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.

  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.

  PMID: 18420158 BACKGROUND

• 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.

  PMID: 17976425 BACKGROUND

• 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.

  PMID: 19124673 BACKGROUND

• 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.

  PMID: 16930356 BACKGROUND

• 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.

  PMID: 23775146 BACKGROUND

• 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.

  PMID: 9674789 BACKGROUND

• 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.

  PMID: 22045363 BACKGROUND

• 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.

  PMID: 7687093 BACKGROUND

• 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.

  PMID: 9091692 BACKGROUND

• 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.

  PMID: 12933939 BACKGROUND

• 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.

  PMID: 16476804 BACKGROUND

• 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.

  PMID: 28794253 DERIVED

MeSH Terms

Conditions

Hypotension

Interventions

Midodrine; Pyridostigmine Bromide

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Pyridinium Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

This study lacked a placebo group and a blinding process Compared with previous studies, which focused on primary autonomic degenerative disorders, our study included more patients with peripheral autonomic neuropathy.

Results Point of Contact

• Title: Jung-Ick Byun
• Organization: SNUH

mr830611@gmail.com

+8224406254

Study Officials

• Kon Chu

  Seoul National University Hospital, Seoul, South Korea

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 2, 2014
• First Posted: December 4, 2014
• Study Start: November 1, 2014
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: October 19, 2021
• Results First Posted: April 17, 2017

Record last verified: 2021-09

Locations

KR (1)