The effect of magnesium in reducing the symptoms of patients with mitral valve prolapse
Design
The study was designed as a clinical trial with a sample size of 30 people for comparison before and after in participants of this study.
Settings and conduct
This study will be performed in Shahid Rajaei Hospital on people with mitral valve prolapse who are eligible for the study. Patients who gave informed consent to participate in the plan will receive 250 mg of magnesium gluconate twice aday for 4 weeks. The final outcomes of the study before and after the intervention will be compared
Participants/Inclusion and exclusion criteria
Exclusion criteria: Previous history of heart disease; Lack of access to tests; Lack of ECG interpretation
Inclusion criteria: Patients with mitral valve prolapse
Intervention groups
Intervention group: 250 mg magnesium gluconate tablets twice aday for four weeks
Main outcome variables
Heart palpitation, chest pain and echocardiographic changes
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210403050827N1
Registration date:2021-04-14, 1400/01/25
Registration timing:prospective
Last update:2021-04-14, 1400/01/25
Update count:0
Registration date
2021-04-14, 1400/01/25
Registrant information
Name
Fariba Rajabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3457 0030
Email address
f.rajabi@abzums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-19, 1400/01/30
Expected recruitment end date
2021-07-21, 1400/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of magnesium treatment in reducing the symptoms of patients with mitral valve prolapse
Public title
The effect of magnesium treatment on the symptoms of mitral valve prolapse
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with mitral valve prolapse
Exclusion criteria:
Previous history of heart disease
Lack of access to tests
Lack of ECG interpretation
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Alborz University of Medical Sciences
Street address
Ethics committee unit; Vice Chancellor for Research; No.20; Saffarian alley; 45 Metri Golshahr street
City
Karaj
Province
Alborz
Postal code
3149779453
Approval date
2021-02-06, 1399/11/18
Ethics committee reference number
IR.ABZUMS.REC.1399.283
Health conditions studied
1
Description of health condition studied
Mitral valve prolapse
ICD-10 code
I34.1
ICD-10 code description
Nonrheumatic mitral (valve) prolapse
Primary outcomes
1
Description
Heart palpitation
Timepoint
Before and after intervention
Method of measurement
Questionnaire
2
Description
Echocardiographic changes
Timepoint
Before and after intervention
Method of measurement
Echocardiography
3
Description
Chest pain
Timepoint
Before and after intervention
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Take 250 mg magnesium gluconate ( Karan, Iran) tablets twice a day for four weeks