Comparing the efficacy of Tadalafil versus Placebo on pulmonary artery systolic pressure and right ventricular function in patients with beta-thalassemia intermedia
5-Phosphodiesterase inhibitors (PDE5Is) like sildenafil or tadalafil are used in treatment of Pulmonary Arterial Hypertension by decreasing vascular tonicity and inducing vasodilation. This study is designed to evaluate tadalafil effect in decreasing pulmonary arterial pressure and eventually improvement in right ventricular function in patients with major and intermedia beta thalassemia.
Inclusion criteria (All of the following) : age more than 15 years ; major beta thalassemia patients or Intermedia beta thalassemia patients ; Pulmonary Arterial Hypertension or Right Ventricular Dysfunction.
Exclusion criteria (One of the following) : age< 15 years ; using nitrates and alpha blockers (except Tamsulosin) at the time of the study ; minor beta thalassemia patients.
This study is a double-blind and will be conduct in parallel for 6 weeks. Before intervention, the patients are evaluated by Ttransthoracic Echocardiography and their pulmonary arterial pressure and function and size of right ventricle are measured. Then, they are randomly divided to two intervention and control groups with 25 members and receive a drug (a daily single dose of tadalafil 40 mg capsule) or placebo (a similar capsule with similar administration to intervention group). After 6 weeks, all patients are evaluated again with the same Transthoracic Echocardiography system and their pulmonary artery pressure and function and size of right ventricle are measured.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013102715178N1
Registration date:2013-11-23, 1392/09/02
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-11-23, 1392/09/02
Registrant information
Name
Rozita Jalalian
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 1219 9591
Email address
r.jalalian@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
1- Babol University of Medical Sciences, Research and Technology Assistance2- Project Executer
Expected recruitment start date
2013-12-01, 1392/09/10
Expected recruitment end date
2014-01-16, 1392/10/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the efficacy of Tadalafil versus Placebo on pulmonary artery systolic pressure and right ventricular function in patients with beta-thalassemia intermedia
Public title
Effects of tadalafil on cardiovascular function in patients with thalassemia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria (All of the following) : age more than 15 years ; major beta thalassemia patients (significant anemia, Hb< 7 and transfusion dependent) or Intermedia beta thalassemia (milder anemia, Hb between 7 and 10 and usually not transfusion dependent) ; Pulmonary Arterial Hypertension or Right Ventricle Dysfunction. Pulmonary Arterial Hypertension : mean pulmonary arterial pressure more than 25 mmHg at rest or more than 30 mmHg in activity (measured by transthoracic echocardiography). Right ventricular dysfunction as increase in right ventricle end-diastolic dimension (base> 4cm, midpart> 3.5) or decrease in function and ejection fraction of right ventricle according to TAPSE index (lesser than 2cm) and S index (lesser than 11cm) measured by transthoracic echocardiography.
Exclusion criteria (One of the following) : age< 15 years ; using nitrates and alpha blockers (except Tamsulosin) at the time of study ; minor beta thalassemia patients
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
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
Babol University of Medical Sciences, Research and Technology Assistance
Street address
University Sq, Ganj Afrooz Av, Babol
City
Babol
Postal code
Approval date
2013-08-27, 1392/06/05
Ethics committee reference number
3012
Health conditions studied
1
Description of health condition studied
Major and Intermedia Beta Thalassemia
ICD-10 code
D56.1
ICD-10 code description
Beta thalassaemia, Thalassaemia: intermedia major
2
Description of health condition studied
Pulmonary Arterial Hypertension
ICD-10 code
I27.2
ICD-10 code description
Other secondary pulmonary hypertension
Primary outcomes
1
Description
Mean pulmonary arterial pressure
Timepoint
Once before beginning of intervention and once 6 weeks after beginning of intervention(At the end of intervention)
Method of measurement
With Transthoracic echocardiography system(CYE-Vivid3)- with doppler, color doppler, m mode, 2d and tissue doppler Modalities.
2
Description
Right ventricular end-diastolic dimension
Timepoint
Once before beginning of intervention and once 6 weeks after beginning of intervention(At the end of intervention)
Method of measurement
With Transthoracic echocardiography system(CYE-Vivid3)- with 2D modality
3
Description
Right ventricular function
Timepoint
Once before beginning of intervention and once 6 weeks after beginning of intervention(At the end of intervention)
Method of measurement
With Transthoracic echocardiography system(CYE-Vivid3)- with M mode modality(for TAPSE) and Tissue doppler modality(for S)
Secondary outcomes
empty
Intervention groups
1
Description
Patients in control group get single daily dose of placebo capsules similar in weight and appearance to tadalafil 40 mg for 6 weeks.
Category
Placebo
2
Description
Patients in intervention group receive a single daily dose of tadalafil (40 mg capsules) for 6 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Roohani Hospital
Full name of responsible person
Street address
Ganj Afrooz Av, Babol
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences, Research and Technology Assistance
Full name of responsible person
Dr. ali Bijani
Street address
University Sq, Ganj Afrooz Av, Babol
City
Babol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol University of Medical Sciences, Research and Technology Assistance
Proportion provided by this source
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
2
Sponsor
Name of organization / entity
No organization (Project Executer)
Full name of responsible person
Dr. Rozita Jalalian
Street address
The Fifth Floor, Pars Complex, In front of Beheshti Hospital, Keshvari Sq, Babol
City
Babol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
No organization (Project Executer)
Proportion provided by this source
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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Roohani Hospital
Full name of responsible person
Dr. Rozita Jalalian
Position
Cardiologist, Fellowship of Echocardiography/ Assistant professor
Other areas of specialty/work
Street address
Ganj Afrooz Av, Babol
City
Babol
Postal code
Phone
+98 11 1223 8301
Fax
Email
Rozita_jalalian@yahoo.comR.jalalian@mubabol.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Mohammadreza Iranian
Position
Medical Student
Other areas of specialty/work
Street address
University Sq, Ganj Afrooz Av, Babol
City
Babol
Postal code
Phone
00
Fax
Email
Driranian@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)