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Inhaled nitrite therapy for pulmonary hypertension in connective tissue diseases

Phase 1
Conditions
Pulmonary artery hypertension in systemic sclerosis patients
Systemic sclerosis
Pulmonary artery hypertension
Inhaled nitrite
Mean pulmonary artery pressure
Registration Number
TCTR20230517002
Lead Sponsor
Mahidol University
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending (Not yet recruiting)
Sex
All
Target Recruitment
23
Inclusion Criteria

1.Systemic sclerosis patients with and without interstitial lung disease.
2.Patients in clinically stable state
3.Do not receive medication which affect platelet function (NSAIDs or anti-platelet drugs) within 2 weeks.
4.Patients who were nonsmokers, not drinking alcohol and not addicting illegal drugs.

Exclusion Criteria

1.The use of organic nitrate and pulmonary vasodilator agents (calcium channel blockers or endothelin receptor antagonists) other than sildenafil.
2.Patients with systolic blood pressure lower than 100 mmHg and/or diastolic blood pressure lower than 70 mmHg
3.Patients with hematocrit lower than 24%
4. Patients with methemoglobin greater than 1%
5.Patients who taking antiplatelet medications.
6.Patients who smoking, drinking alcohols and being a drug addiction.
7. Patients with glomerular filtration rate lower than 60 mL/min/1.73 m2
8.Patients with severe co-morbidities (heart failure, ischemic heart diseases, COPD, diabetes mellitus, thyroid disease, chronic kidney disease)
9.Pregnant patients
10.Patient who denied or withdrawn from the study

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Mean pulmonary artery pressure Every 1 min during intrite inhalation Right heart catheterization
Secondary Outcome Measures
NameTimeMethod
Pulmonary vascular resistance Every 1 min during intrite inhalation Right heart catheterization
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