Effects of tadalafil on cardiovascular function in patients with thalassemia

Not Applicable

Conditions: Condition 1: Major and Intermedia Beta Thalassemia. Condition 2: Pulmonary Arterial Hypertension.
Beta thalassaemia, Thalassaemia: intermedia major
Other secondary pulmonary hypertension

Registration Number: IRCT2013102715178N1

Lead Sponsor: Babol University of Medical Sciences, Research and Technology Assistance

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 50

Inclusion 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

Exclusion Criteria

Not provided

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.;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.;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 Outcome Measures