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Comparison of inhaled nebulized nitrite and oral sildenafil VS oral sildenafil alone in the treatment of beta-thalassemia patients with pulmonary hypertension

Comparison of inhaled nebulized nitrite and oral sildenafil VS oral sildenafil alone in the treatment of beta-thalassemia patients with pulmonary hypertension

Status
Recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20180913002
Enrollment
50
Registered
2018-09-13
Start date
2018-08-01
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Beta&#45

Interventions

Oral sildenafil at least 60 mg/day plus inhaled nebulized nitrite 15 mg BID,Oral sildenafil at least 60 mg/day
Experimental Drug,Active Comparator Drug
Oral sildenafil plus inhaled nebulized nitrite,Oral sildenafil

Sponsors

Department of Pharmacology at Faculty of Science, Mahidol University
Lead Sponsor
Cooley&#39
Collaborator
s anemia foundation
Collaborator

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: Age ≥ 18 years old Beta&#45;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

Exclusion criteria: &#45;Currently use organic nitrate &#45;Currently treated with other PAH &#45;specific drugs (except sildenafil) &#45;Hb 4% &#45;Symptomatic left sided heart failure &#45;History ischemic heart disease &#45;COPD &#45;Uncontrolled DM &#45;Uncontrolled thyroid disorder &#45;Cirrhosis &#45;Pregnancy &#45;No inform consent

Design outcomes

Primary

MeasureTime frame
Change of six minute walk test 3 months Standard 6 minutes walk test measurement

Secondary

MeasureTime frame
Change of echocardiography 3 months Echocardiogram,change of NTproBNP 3 months Blood for NTproBNP

Countries

Thailand

Contacts

Public ContactThinnakrit Sasirapha

Cardiology fellowship

doctortui765@gmail.com0897117999

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026