Effects of tadalafil on cardiovascular function in patients with thalassemia

Comparing the efficacy of Tadalafil versus Placebo on pulmonary artery systolic pressure and right ventricular function in patients with beta-thalassemia intermedia

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT2013102715178N1

Enrollment

Registered

2013-11-23

Start date

2013-12-01

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Intervention 1: Patients in control group get single daily dose of placebo capsules similar in weight and appearance to tadalafil 40 mg for 6 weeks. Intervention 2: Patients in intervention group rece

Placebo

Treatment - Drugs

Patients in control group get single daily dose of placebo capsules similar in weight and appearance to tadalafil 40 mg for 6 weeks.

Patients in intervention group receive a single daily dose of tadalafil (40 mg capsules) for 6 weeks.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria (All of the following) : age more than 15 years ; major beta thalassemia patients (significant anemia, Hb 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

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
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).	—

Measure

Time frame

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).

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Countries

Iran (Islamic Republic of)

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026