Comparison of the effects of valsartan versus sildenafil on pulmonary arterial pressure in thalassemia major and intermedia patients with pulmonary hypertension
The aim of this study is to compare the effects of valsartan with sildenafil on treatment of increased pulmonary arterial pressure in thalassemia major and intermediate patients who suffer from pulmonary hypertension. Valsartan has direct effects on cardiac systolic and diastolic function which could reduce pulmonary arterial pressure. It would be a new pathway in the treatment of pulmonary hypertension in such patients and would be helpful to improve their quality of life. In this study 100 known cases of thalassemia major and intermediate in Firuzgar hospital which have pulmonary arterial pressure more than 25 mmhg, will be included in the study. Patients will be excluded if any adverse drug reaction occurs or if the dyspnea will be worse. Fifty patients will receive valsartan and the next 50 will receive sildenafil. Patients will be followed via echocardiography (three times) and cardiac indexes will be measured during six months and will be compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012100611022N1
Registration date:2012-12-09, 1391/09/19
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-12-09, 1391/09/19
Registrant information
Name
Mohamad Namvar
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 4406 3741
Email address
s-raeisi@student.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2012-10-22, 1391/08/01
Expected recruitment end date
2012-11-21, 1391/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of valsartan versus sildenafil on pulmonary arterial pressure in thalassemia major and intermedia patients with pulmonary hypertension
Public title
Valsartan therapy in the treatment of thalassemia-induced dyspnea
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: thalassemia intermedia or major, age ≥ 10 years, systolic pulmonary artery pressure ≥ mmhg25.
Exclusion criteria: Allergy to sildenafil or valsartan, incidence the side effects of drugs, no consent to continue the study, using other drugs which are in interaction with study drugs, increased NYHA function class of dyspnea
Age
From 10 years old to 100 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
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Tehran University of Medical Sciences
Street address
Central Building of Tehran University of Medical Sciences, Qods st, Enghelab Sq, Tehran
City
Tehran
Postal code
Approval date
2012-10-02, 1391/07/11
Ethics committee reference number
18147-30-02-91
Health conditions studied
1
Description of health condition studied
secondary Pulmonary hypertension due to the Thalassemia
ICD-10 code
I27.2
ICD-10 code description
Other secondary pulmonary hypertension
Primary outcomes
1
Description
Pulmonary arterial pressure
Timepoint
begining of the study, the last day of first month and the last day of 6th month
Method of measurement
Echocardiography
Secondary outcomes
1
Description
Dyspnea
Timepoint
begining of the study, the last day of first month and the last day of 6th month
Method of measurement
NYHA function class
Intervention groups
1
Description
Group 2 patients (as Intervention) will take valsartan drug 20 mg PO daily for six months.
Category
Treatment - Drugs
2
Description
Group 1 patients (as control) will take Sildenafil drug 25 mg PO twice per day for six months.