The aim of this study is to compare efficacy of Midodrine in the treatment of vasovagal syncope. Patient who had at least one episode of syncope during previous 6-month period and a positive tilt-table test are included in the study. Patients are excluded if they had other causes of syncope; cardiovascular and /or systemic disease; systolic blood pressure >150 mmHg or diastolic blood pressure >95 mmHg; thyrotoxicosis; renal failure; pheochromocytoma. During five years, a total of 100 patients are randomly allocated to treatment with Midodrine or placebo. Treatment drug are given at a starting dose of 5 mg three times a day and increased up to a dose of 10 mg three times a day if required. Patients are followed every week for 3 weeks and every 2 months for 12 months. Primary outcome is frequency of syncope recurrence 6-month and one year after study. Secondary outcomes are satisfaction score and quality of life which will be measured 6-month and one year after study.
General information
Acronym
MVP-VVS
IRCT registration information
IRCT registration number:IRCT138803061965N1
Registration date:2009-09-15, 1388/06/24
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2009-09-15, 1388/06/24
Registrant information
Name
Majid Haghjoo
Name of organization / entity
Rajaie Cardiovascular Medical and Research Center
Country
Iran (Islamic Republic of)
Phone
+98 21 2392 2163
Email address
majid.haghjoo@gmail.com
Recruitment status
Recruitment complete
Funding source
Rajaie Cardiovascular Medical and Research Center
Expected recruitment start date
2006-07-14, 1385/04/23
Expected recruitment end date
2011-12-31, 1390/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Prospective Evaluation of the Midodrine Efficacy in the Treatment of Vasovagal Syncope: A Randomized Placebo-Controlled Study
Public title
Midodrine Versus Placebo in VasoVagal Syncope
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: (1) a frequency of at least one episode of syncope during previous 6-month and (2) a positive head-up tilt test.
Exclusion criteria: (1) other causes of syncope; (2) cardiovascular
and /or systemic disease; or (3) systolic blood pressure >150 mmHg or diastolic blood pressure >95 mmHg; or (4) thyrotoxicosis; or (5) renal failure; or (6) pheochromocytoma.
Age
From 15 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Rajaie Cardiovascular Medical and Research Center
Street address
Rajaie Cardiovascular Medical and Research Center, Melklat Park, Vali-e-Asr Steet
City
Tehran
Postal code
1996911151
Approval date
2006-07-14, 1385/04/23
Ethics committee reference number
86/13
Health conditions studied
1
Description of health condition studied
Vasovagal syncope
ICD-10 code
R55
ICD-10 code description
Syncope and collapse
Primary outcomes
1
Description
Syncope recurrence
Timepoint
6-monthe and one year after treatment
Method of measurement
History
Secondary outcomes
1
Description
Satisfaction score
Timepoint
6-month and one year after treatment
Method of measurement
History (score 0=no response, score 6=excellent response)
2
Description
Quality of life
Timepoint
6-month and one year after treatment
Method of measurement
Endicott quality of life questionnaire
Intervention groups
1
Description
Midodrine 5 mg tid if neccessary 10 mg tid for one year
Category
Treatment - Drugs
2
Description
Placebo 5 mg tid if neccessary 10 mg tid for one year
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rajaie Cardiovascular Medical and Research Center
Full name of responsible person
Dr. Majid Haghjoo
Street address
Department of Pacemeker and Electrophysiology, Rajaie Cardiovascular Medical and Research Center, Mellat Park, Vali-e-Asr Street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research department of Rajaie Cardiovascular Medical and Research Center
Full name of responsible person
Dr. Avisa Tabib
Street address
Research department of Rajaie Cardiovascular Medical and Research Center, Mellat Park, Vali-e-Asr Street
City
Tehran
Grant name
Grant code / Reference number
86/13
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research department of Rajaie Cardiovascular Medical and Research Center
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Rajaie Cardiovascular Medical and Research Center
Full name of responsible person
Dr. Human Bakhshandeh
Position
Assistant Professor
Other areas of specialty/work
Street address
Research Department, Rajaie Cardiovascular Medical and Research Center, Mellat Park, Vali-e-Asr Strett
City
Tehran
Postal code
1996911151
Phone
+98 21 2392 2163
Fax
+98 21 2204 2026
Email
bakhshandeh@rhc.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Pacemaker and Electrophysiology, Rajaie Cardiovascular Medical and Research Center
Full name of responsible person
Dr. Majid Haghjoo
Position
Associate Professor
Other areas of specialty/work
Street address
Department of Pacemaker and Electrophysiology, Rajaie Cardiovascular Medical and Research Center, Mellat Park, Vali-e-Asr Street