Comparison of inhaled nebulized nitrite and oral sildenafil VS oral sildenafil alone in the treatment of beta-thalassemia patients with pulmonary hypertensio
Phase 2
Recruiting
- Conditions
- Beta-thalassemia with pulmonary hypertensionBet thalassemiapulmonary hypertension
- Registration Number
- TCTR20180913002
- Lead Sponsor
- Department of Pharmacology at Faculty of Science, Mahidol University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
Age ≥ 18 years old
Beta-thalassemia patients diagnosed with pulmonary hypertension type 5 (WHO criteria)
Right heart catheterization ; MPAP ≥ 25 mmHg and PCWP < 15 mmHg
TR Vmax ≥ 2.8 m/s or RVSP ≥ 35 mmHg will undergo to right heart catherization
Exclusion Criteria
-Currently use organic nitrate
-Currently treated with other PAH -specific drugs (except sildenafil)
-Hb < 7 mg/dL
-Plasma methemoglobin level > 4%
-Symptomatic left sided heart failure
-History ischemic heart disease
-COPD
-Uncontrolled DM
-Uncontrolled thyroid disorder
-Cirrhosis
-Pregnancy
-No inform consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change of six minute walk test 3 months Standard 6 minutes walk test measurement
- Secondary Outcome Measures
Name Time Method Change of echocardiography 3 months Echocardiogram,change of NTproBNP 3 months Blood for NTproBNP