Assessment of Midodrine in the Prevention of Vasovagal Syncope: The Prevention of Syncope Trial IV (POST 4)
This study is currently recruiting participants.
Verified January 2013 by 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: January 11, 2013
Last verified: January 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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 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. ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- A secondary outcome will be the time between the first and second syncope recurrences. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- A secondary outcome will be the frequency of syncopal spells. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- A secondary outcome is the number, duration, and severity of presyncopal spells (as measured with the Calgary Presyncope Scale(19)). [ Time Frame: 1 year. ] [ Designated as safety issue: No ]
- A secondary outcomes will be quality of life as measured by the EQ-5D and the ISQL. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 108 |
| Study Start Date: | November 2011 |
| Estimated Study Completion Date: | November 2015 |
| Estimated Primary Completion Date: | November 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: midodrine hydrochloride pills |
Drug: midodrine hydrochloride
midodrine hydrochloride or placebo pills 2.5 mg three times a day for 12 months
Other Name: Brand name for the drug is midodrine.
|
| Placebo Comparator: oral placebo or sugar pill |
Drug: midodrine hydrochloride
midodrine hydrochloride or placebo pills 2.5 mg three times a day for 12 months
Other Name: Brand name for the drug is midodrine.
Drug: matching placebo
matching placebo 2.5 mg three times a day for 12 months
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
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, 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 | |
| Canada, New Brunswick | |
| New Brunswick Heart Centre | Recruiting |
| Saint John, New Brunswick, Canada, E2L 4L2 | |
| Contact: Ricardo Bessoudo, MD 506-648-6000 | |
| Principal Investigator: Ricardo Bessoudo, MD | |
| Canada, Ontario | |
| 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 | |
| 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 | |
Sponsors and Collaborators
Dr. Bob Sheldon
Vanderbilt University
More Information
No publications provided by University of Calgary
Additional 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: | January 11, 2013 |
| Health Authority: | Canada: Health Canada United States: Institutional Review Board |
Keywords provided by 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 Pharmacologic Actions Vasoconstrictor Agents Cardiovascular Agents Therapeutic Uses 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 May 22, 2013