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Assessment of Midodrine in the Prevention of Vasovagal Syncope: The Prevention of Syncope Trial IV (POST 4)
This study is currently recruiting participants.
Verified August 2016 by Dr. Bob Sheldon, University of Calgary
Sponsor:
Dr. Bob Sheldon
Collaborator:
Vanderbilt University
Information provided by (Responsible Party):
Dr. Bob Sheldon, University of Calgary
ClinicalTrials.gov Identifier:
NCT01456481
First received: October 14, 2011
Last updated: August 29, 2016
Last verified: August 2016
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Vasovagal Syncope | Drug: midodrine hydrochloride Drug: matching placebo | Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Assessment of Midodrine in the Prevention of Vasovagal Syncope: The Prevention of Syncope Trial IV (Post 4) |
Resource links provided by NLM:
MedlinePlus related topics:
Fainting
Drug Information available for:
Midodrine hydrochloride
U.S. FDA Resources
Further study details as provided by Dr. Bob Sheldon, University of Calgary:
Primary Outcome Measures:
- The primary outcome measure will be the proportion of patients having at least one syncope recurrence. [ Time Frame: 1 year. ]
Secondary Outcome Measures:
- A secondary outcome will be the time between the first and second syncope recurrences. [ Time Frame: 1 year ]
- A secondary outcome will be the frequency of syncopal spells. [ Time Frame: 1 year ]
- A secondary outcome is the number, duration, and severity of presyncopal spells (as measured with the Calgary Presyncope Scale(19)). [ Time Frame: 1 year. ]
- A secondary outcomes will be quality of life as measured by the EQ-5D and the ISQL. [ Time Frame: 1 year ]
| Estimated Enrollment: | 108 |
| Study Start Date: | November 2011 |
| Estimated Study Completion Date: | July 2017 |
| Estimated Primary Completion Date: | May 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: midodrine hydrochloride pills |
Drug: midodrine hydrochloride
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.
Other Name: Brand name for the drug is midodrine.
|
| Placebo Comparator: oral placebo or sugar pill |
Drug: midodrine hydrochloride
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.
Other Name: Brand name for the drug is midodrine.
Drug: matching placebo
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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01456481
Please refer to this study by its ClinicalTrials.gov identifier: NCT01456481
Contacts
| Contact: Dr. Robert S Sheldon, MD, PhD | 403-220-8191 | sheldon@ucalgary.ca |
Locations
| United States, Minnesota | |
| University of Minnesota | Recruiting |
| Minneapolis, Minnesota, United States, 55455 | |
| Contact: David Benditt, MD 612-625-4401 bendi001@umn.edu | |
| Contact: Brandy Harrington, RN 612-625-4401 satc0001@umn.edu | |
| Principal Investigator: David Benditt, MD | |
| United States, Tennessee | |
| Vanderbilt University | Recruiting |
| Nashville, Tennessee, United States, 37232 | |
| Contact: Satish R Raj, MD 615-343-6499 | |
| Principal Investigator: Satish R Raj, MD | |
| Canada, Alberta | |
| University of Calgary | Recruiting |
| Calgary, Alberta, Canada, T2N 4Z6 | |
| Contact: Dr. Robert S Sheldon, MD, PhD 403-220-8191 sheldon@ucalgary.ca | |
| Principal Investigator: Dr. Robert S Sheldon, MD PhD | |
| Alberta Health Services - Royal Alexandra Hospital | Recruiting |
| Edmonton, Alberta, Canada, T5H 3V9 | |
| Contact: Evan Lockwood, MD 780-735-4489 | |
| Principal Investigator: Evan Lockwood, MD | |
| Royal Alexandra Hospital | Recruiting |
| Edmonton, Alberta, Canada, T5H 3V9 | |
| Contact: Evan Lockwood, MD 780-937-9767 evan.lockwood@arrhythmiaclinic.ca | |
| Contact: Sylvia Martin, RN 780-735-4489 | |
| Principal Investigator: Evan Lockwood, MD | |
| Red Deer Regional Hospital | Recruiting |
| Red Deer, Alberta, Canada, T4N 4E7 | |
| Contact: Aldo Furlani, MD 403-356-4201 Aldo.Furlani@albertahealthservices.ca | |
| Contact: Craig Hollingshead, RRT 403-356-4201 craig@centralalbertaresearch.com | |
| Principal Investigator: Aldo Furlani, MD | |
| Canada, British Columbia | |
| Victoria Cardiac Arrythmia Trials | Recruiting |
| Victoria, British Columbia, Canada, V8R 4R2 | |
| Contact: Chris Lane, MD 250-595-0400 | |
| Contact: Deborah Parfett, RN 250-595-0400 | |
| Principal Investigator: Chris Lane, MD | |
| Canada, Manitoba | |
| St. Boniface General Hospital | Recruiting |
| St. Boniface, Manitoba, Canada, R2H 2A6 | |
| Contact: Colette Seifer, MD 204-237-2977 | |
| Contact: Rebecca Medeiros, RN 204-237-2380 | |
| Principal Investigator: Colette Seifer, MD | |
| Canada, New Brunswick | |
| New Brunswick Heart Centre | Recruiting |
| Saint John, New Brunswick, Canada, E2L 4L2 | |
| Contact: Ricardo Bessoudo, MD 506-648-6000 | |
| Contact: Shavon Whalen, RN 506-648-7121 | |
| Principal Investigator: Ricardo Bessoudo, MD | |
| Canada, Nova Scotia | |
| Queen E II Health Sciences Centre | Recruiting |
| Halifax, Nova Scotia, Canada, B3H 3A6 | |
| Contact: Ratika Parkash, MD Ratika.Parkash@cdha.nshealth.ca | |
| Contact: Ann Fearon, RN 902-473-1142 Ann.Fearon@cdha.nshealth.ca | |
| Principal Investigator: Ratika Parkash, MD | |
| Canada, Ontario | |
| Hamilton Health Sciences | Recruiting |
| Hamilton, Ontario, Canada, L8L 2X2 | |
| Contact: Carlos Morillo, MD 905-521-2100 ext 40311 | |
| Contact: Victoria Malcolm, RN 905-527-4322 ext 44506 | |
| Principal Investigator: Carlos Morillo, MD | |
| University of Ottawa Heart Institute | Recruiting |
| Ottawa, Ontario, Canada, K1Y 4W7 | |
| Contact: David Birnie, MD 613-761-4705 | |
| Principal Investigator: David Birnie, MD | |
| Canada, Quebec | |
| Hopital Sacre Coeur de Montreal | Recruiting |
| Montreal, Quebec, Canada, H4J 1C5 | |
| Contact: Teresa Kus, MD 514-338-2222 ext 2571 teresa.kus@umontreal.ca | |
| Contact: Ann Langlois, RN 514-338-2222 ext 3722 a-langlois@crhsc.rtss.qc.ca | |
| Principal Investigator: Teresa Kus, MD | |
| Centre Hospitalier Universitaire de Sherbrooke | Recruiting |
| Sherbrooke, Quebec, Canada, J1H 5N4 | |
| Contact: Felix Ayala-Paredes, MD 819-346-1110 ext 12826 | |
| Principal Investigator: Felix Ayala-Paredes, MD | |
| Canada, Saskatchewan | |
| Prairie Vascular Research Network/Regina General Hospital | Recruiting |
| Regina, Saskatchewan, Canada, S4P 0W5 | |
| Contact: Omar Sultan, MD sultanomar30@gmail.com | |
| Contact: Sheila Kelly, RN 306-522-7275 sheila@skresearch.com | |
| Principal Investigator: Omar Sultan, MD | |
| Saskatoon Cardiology Consultants/Royal University Hospital | Recruiting |
| Saskatoon, Saskatchewan, Canada, S7K 3H1 | |
| Contact: Kelly Coverett, MD 306-975-9000 coverett@gmail.com | |
| Contact: Sharleen Maley, RN 306-978-8307 sharleen.maley@usask.ca | |
| Principal Investigator: Kelly Coverett, MD | |
| Poland | |
| Medical University of Lodz | Not yet recruiting |
| Lodz, Poland, 93-005 | |
| Contact: Malgorzata Lelonek, MD mlelonek@poczta.fm | |
| Principal Investigator: Malgorzata Lelonek, MD | |
Sponsors and Collaborators
Dr. Bob Sheldon
Vanderbilt University
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Dr. Bob Sheldon, Professor of Cardiac Sciences, Medicine and Medical Genetics, University of Calgary |
| ClinicalTrials.gov Identifier: | NCT01456481 History of Changes |
| Other Study ID Numbers: |
CIHR#243314 |
| Study First Received: | October 14, 2011 |
| Last Updated: | August 29, 2016 |
Keywords provided by Dr. Bob Sheldon, University of Calgary:
|
reflex fainting vasovagal syncope midodrine |
Additional relevant MeSH terms:
|
Syncope Syncope, Vasovagal Unconsciousness Consciousness Disorders Neurobehavioral Manifestations Neurologic Manifestations Nervous System Diseases Signs and Symptoms Orthostatic Intolerance Primary Dysautonomias Autonomic Nervous System Diseases Midodrine |
Sympathomimetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Vasoconstrictor Agents Adrenergic alpha-1 Receptor Agonists Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on July 07, 2017