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Assessment of Midodrine in the Prevention of Vasovagal Syncope: The Prevention of Syncope Trial IV (POST 4)

Primary Purpose

Vasovagal Syncope

Status
Active
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
midodrine hydrochloride
matching placebo
Sponsored by
Dr. Bob Sheldon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vasovagal Syncope focused on measuring reflex fainting, vasovagal syncope, midodrine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients will be eligible if they have:

    • ≥2 syncopal spells in the year preceding enrolment, and
    • ≥ -2 points on the Syncope Symptom Score for Structurally Normal hearts, and
    • Age ≥ 18 years with informed consent.

Exclusion Criteria:

  • Patients will be excluded if they have:

    • other causes of syncope, such as ventricular tachycardia, complete heart block, postural hypotension or hypersensitive carotid sinus syndrome,
    • an inability to give informed consent,
    • important valvular, coronary, myocardial or conduction abnormality or significant arrhythmia,
    • hypertrophic cardiomyopathy,
    • a permanent pacemaker,
    • a seizure disorder,
    • urinary retention,
    • hypertension defined as >140/90 mm Hg,
    • hepatic disease,
    • glaucoma or
    • a 5-minute stand test resulting in diagnoses of Postural Orthostatic Tachycardia Syndrome or Orthostatic Hypotension.

Sites / Locations

  • University of Minnesota
  • Vanderbilt University
  • University of Calgary
  • Alberta Health Services - Royal Alexandra Hospital
  • Royal Alexandra Hospital
  • Red Deer Regional Hospital
  • Victoria Cardiac Arrythmia Trials
  • St. Boniface General Hospital
  • New Brunswick Heart Centre
  • Queen E II Health Sciences Centre
  • Hamilton Health Sciences
  • University of Ottawa Heart Institute
  • Hopital Sacre Coeur de Montreal
  • Centre Hospitalier Universitaire de Sherbrooke
  • Prairie Vascular Research Network/Regina General Hospital
  • Saskatoon Cardiology Consultants/Royal University Hospital
  • Medical University of Lodz

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

midodrine hydrochloride pills

oral placebo or sugar pill

Arm Description

Outcomes

Primary Outcome Measures

The primary outcome measure will be the proportion of patients having at least one syncope recurrence.

Secondary Outcome Measures

A secondary outcome will be the time between the first and second syncope recurrences.
A secondary outcome will be the frequency of syncopal spells.
A secondary outcome is the number, duration, and severity of presyncopal spells (as measured with the Calgary Presyncope Scale(19)).
A secondary outcomes will be quality of life as measured by the EQ-5D and the ISQL.

Full Information

First Posted
October 14, 2011
Last Updated
November 1, 2022
Sponsor
Dr. Bob Sheldon
Collaborators
Vanderbilt University
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1. Study Identification

Unique Protocol Identification Number
NCT01456481
Brief Title
Assessment of Midodrine in the Prevention of Vasovagal Syncope: The Prevention of Syncope Trial IV
Acronym
POST 4
Official Title
Assessment of Midodrine in the Prevention of Vasovagal Syncope: The Prevention of Syncope Trial IV (Post 4)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 2011 (undefined)
Primary Completion Date
December 20, 2018 (Actual)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr. Bob Sheldon
Collaborators
Vanderbilt University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
About 20% of adults faint recurrently. These patients are often highly symptomatic, have problems with employment and driving and have reduced quality of life. There are no therapies that have withstood the test of adequately designed and conducted randomized clinical trials. Midodrine is a prodrug whose metabolite is an alpha-1 adrenergic agonist that increases venous return to the heart and raises blood pressure. There is considerable lower level evidence that it might prevent vasovagal syncope. The investigators will test the hypothesis that Midodrine prevents recurrences of syncope in patients with moderate to severe vasovagal syncope.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vasovagal Syncope
Keywords
reflex fainting, vasovagal syncope, midodrine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
134 (Actual)

8. Arms, Groups, and Interventions

Arm Title
midodrine hydrochloride pills
Arm Type
Active Comparator
Arm Title
oral placebo or sugar pill
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
midodrine hydrochloride
Other Intervention Name(s)
Brand name for the drug is midodrine.
Intervention Description
Target dose is midodrine hydrochloride or placebo pills 10 mg three times a day for 12 months. The starting dose is 5mg q4h x3, and if tolerated a forced titration up to 10mg/dose. If there is an intolerance, then the dose can be reduced to 2.5mg/dose.
Intervention Type
Drug
Intervention Name(s)
matching placebo
Intervention Description
The target dose in this study is 10mg q4h x3 for 12 months. The starting dose is 5mg q4h x3, and if tolerated a forced titration up to 10mg/dose. If there is an intolerance, then the dose can be reduced to 2.5mg/dose.
Primary Outcome Measure Information:
Title
The primary outcome measure will be the proportion of patients having at least one syncope recurrence.
Time Frame
1 year.
Secondary Outcome Measure Information:
Title
A secondary outcome will be the time between the first and second syncope recurrences.
Time Frame
1 year
Title
A secondary outcome will be the frequency of syncopal spells.
Time Frame
1 year
Title
A secondary outcome is the number, duration, and severity of presyncopal spells (as measured with the Calgary Presyncope Scale(19)).
Time Frame
1 year.
Title
A secondary outcomes will be quality of life as measured by the EQ-5D and the ISQL.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients will be eligible if they have: ≥2 syncopal spells in the year preceding enrolment, and ≥ -2 points on the Syncope Symptom Score for Structurally Normal hearts, and Age ≥ 18 years with informed consent. Exclusion Criteria: Patients will be excluded if they have: other causes of syncope, such as ventricular tachycardia, complete heart block, postural hypotension or hypersensitive carotid sinus syndrome, an inability to give informed consent, important valvular, coronary, myocardial or conduction abnormality or significant arrhythmia, hypertrophic cardiomyopathy, a permanent pacemaker, a seizure disorder, urinary retention, hypertension defined as >140/90 mm Hg, hepatic disease, glaucoma or a 5-minute stand test resulting in diagnoses of Postural Orthostatic Tachycardia Syndrome or Orthostatic Hypotension.
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada
Facility Name
Alberta Health Services - Royal Alexandra Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5H 3V9
Country
Canada
Facility Name
Royal Alexandra Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5H 3V9
Country
Canada
Facility Name
Red Deer Regional Hospital
City
Red Deer
State/Province
Alberta
ZIP/Postal Code
T4N 4E7
Country
Canada
Facility Name
Victoria Cardiac Arrythmia Trials
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8R 4R2
Country
Canada
Facility Name
St. Boniface General Hospital
City
St. Boniface
State/Province
Manitoba
ZIP/Postal Code
R2H 2A6
Country
Canada
Facility Name
New Brunswick Heart Centre
City
Saint John
State/Province
New Brunswick
ZIP/Postal Code
E2L 4L2
Country
Canada
Facility Name
Queen E II Health Sciences Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 3A6
Country
Canada
Facility Name
Hamilton Health Sciences
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 2X2
Country
Canada
Facility Name
University of Ottawa Heart Institute
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4W7
Country
Canada
Facility Name
Hopital Sacre Coeur de Montreal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4J 1C5
Country
Canada
Facility Name
Centre Hospitalier Universitaire de Sherbrooke
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
Prairie Vascular Research Network/Regina General Hospital
City
Regina
State/Province
Saskatchewan
ZIP/Postal Code
S4P 0W5
Country
Canada
Facility Name
Saskatoon Cardiology Consultants/Royal University Hospital
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7K 3H1
Country
Canada
Facility Name
Medical University of Lodz
City
Lodz
ZIP/Postal Code
93-005
Country
Poland

12. IPD Sharing Statement

Citations:
PubMed Identifier
34339231
Citation
Sheldon R, Faris P, Tang A, Ayala-Paredes F, Guzman J, Marquez M, Morillo CA, Krahn AD, Kus T, Ritchie D, Safdar S, Maxey C, Raj SR; POST 4 investigators. Midodrine for the Prevention of Vasovagal Syncope : A Randomized Clinical Trial. Ann Intern Med. 2021 Oct;174(10):1349-1356. doi: 10.7326/M20-5415. Epub 2021 Aug 3.
Results Reference
derived
PubMed Identifier
22610268
Citation
Raj SR, Faris PD, McRae M, Sheldon RS. Rationale for the prevention of syncope trial IV: assessment of midodrine. Clin Auton Res. 2012 Dec;22(6):275-80. doi: 10.1007/s10286-012-0167-5. Epub 2012 May 19.
Results Reference
derived

Learn more about this trial

Assessment of Midodrine in the Prevention of Vasovagal Syncope: The Prevention of Syncope Trial IV

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