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Effect of inhaled nebulized nitrite on pulmonary arterial pressure in thalassemia patients with pulmonary arterial hypertensio

Phase 1
Completed
Conditions
Thalassemiapulmonary hypertension
thalassemia
pulmonary hypertension
inhaled nitrite
Registration Number
TCTR20150518002
Lead Sponsor
Mahidol University
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
50
Inclusion Criteria

beta-thalassemia/HbE
Elevated TRV (> 2.5 m/s)
18 years or older
Hb concentration at least 7 g/dl
MetHb not over 5%
Normal systemic blood pressure
No other underlying diseases
No smoking, alcohol and drug abuse
Willing to join the study
Willing to provide written inform consent

Exclusion Criteria

Age < 18 years
Hb concentration < 8 g/dl or Hct < 24%
Hypotension/hypertension, or has uncontrolled systemic hypertension (<100/70 mmHg and > 160/100 mmHg)
Has a history of portal hypertension or chronic liver disease
History of orthostatic hypotension or at the time of screening
G6PD deficiency or any contraindication to receiving methylene blue
Is currently pregnant or breastfeeding or intends to become pregnant
Has severe or chronic other diseases (heart failure, myocardial infraction, COPD, DM, thyroid, renal insufficiency, and malignancy)
Known or suspected hypersensitivity or allergic to sodium nitrite or sodium nitrate
Want to drop out of the study
Reluctant to provide written inform consent

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Change in pulmonary arterial pressure During and 0&#45;30 min after nebulization Right heart catherization,Change in pulmonary arterial pressure During and 0&#45;30 min after nebulization Echocardiography
Secondary Outcome Measures
NameTimeMethod
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