Comparison of sildenafil effects and placebo on mortality and morbidity in patients with severe mitral stenosis and reactive pulmonary hypertension after mitral valve replacement
Pulmonary hypertension is an important prognostic factor for mortality and morbidity in patients with severe mitral stenosis. To the best of our knowledge, there is not specific and effective treatment for these patients. So we will use sildenafil 25 milligrams three times a day, from 3 days before to 6 weeks after mitral valve replacement surgery, in randomized pattern. For evaluation of sildenafil effects, we will compare pulmonary artery pressure and left ventricular function and mortality rate, before and 6 weeks after operation.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014072818625N1
Registration date:2014-09-09, 1393/06/18
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-09-09, 1393/06/18
Registrant information
Name
Tahereh Davarpasand
Name of organization / entity
Tehran University of Medical Sciences/ Tehran Heart Center
Country
Iran (Islamic Republic of)
Phone
+98 88029600
Email address
davarpasand@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran Heart Center
Expected recruitment start date
2014-09-06, 1393/06/15
Expected recruitment end date
2015-09-06, 1394/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of sildenafil effects and placebo on mortality and morbidity in patients with severe mitral stenosis and reactive pulmonary hypertension after mitral valve replacement
Public title
prognostic effect of sildenafil in patients with severe mitral stenosis and reactive pulmonary hypertension candidate for mitral valve replacement at Tehran Heart Center
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with severe mitral stenosis; Pulmonary artery pressure more than 35 mm Hg in trans esophageal echocardiography; Reactive pulmonary hypertension according right heart catheterization (difference between mean pulmonary artery pressure and Pulmonary Capillary Wedge Pressure> 12mmhg)
Exclusion criteria: Necessity of nitrate; Significant hypotension after first dose of sildensfil; Mitral regurgitation more severe than moderate degree; Necessity of aortic or tricuspid valve replacement; Concomitant Coronary artery bypasses graft surgery
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
62
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Trans esophageal echocardiography 3 days before and 6 weeks after surgery by one echocardiologist
sildenafil 25 mg TDS from 3 days befor surgery until 6 weeks after surgery in randomized pattern
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences/Tehran Heart Center
Street address
North kargar Street
City
Tehran
Postal code
1411713138
Approval date
2013-09-13, 1392/06/22
Ethics committee reference number
675
Health conditions studied
1
Description of health condition studied
Reactive Pulmonary Hypertension
ICD-10 code
I27.8
ICD-10 code description
Other specified pulmonary heart diseases
2
Description of health condition studied
severe mitral stenosis
ICD-10 code
I05.0
ICD-10 code description
Mitral stenosis
Primary outcomes
1
Description
Pulmonary Artery Pressure
Timepoint
7 days before mitral valve replacement/ 6 week after mitral valve replacement
Method of measurement
Transthoracic Echocardiography
2
Description
Left Ventricular Ejection Fraction
Timepoint
7 days before mitral valve replacement/ 6 week after mitral valve replacement
Method of measurement
Transthoracic Echocardiography
Secondary outcomes
empty
Intervention groups
1
Description
Patients with severe mitral stenosis and reactive pulmonary hypertension, who are candidate for elective mitral valve replacement using a 1: 1 method, are randomly divided into two groups: Group 1(intervention) patients will be administrated three days prior to surgery, oral sildenafil 25 mg three times a day. At firs postoperative day, Sildenafil Dosage will be increased to 50 mg three times a day.
Category
Treatment - Drugs
2
Description
Second (control) group will receive placebo during study period.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran Heart Center
Full name of responsible person
Tahereh Davarpasand
Street address
North Kargar Street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran Heart Center
Full name of responsible person
Tahereh Davarpasand
Street address
North Kargar Street
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?