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Inhaled nitrite therapy for pulmonary hypertension in connective tissue diseases

Inhaled nitrite therapy for pulmonary hypertension in connective tissue diseases

Status
Active, not recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20230517002
Enrollment
23
Registered
2023-05-17
Start date
2023-07-03
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

Pulmonary artery hypertension in systemic sclerosis patients Systemic sclerosis Pulmonary artery hypertension Inhaled nitrite Mean pulmonary artery pressure

Interventions

None listed

Sponsors

Mahidol University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

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

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 Patient who denied or withdrawn from the study

Design outcomes

Primary

MeasureTime frame
Mean pulmonary artery pressure Every 1 min during intrite inhalation Transthoracic echocardiogram

Secondary

MeasureTime frame
Max tricuspid valve regurgitation velocity Every 1 min during intrite inhalation Transthoracic echocardiogram

Countries

Thailand

Contacts

Public ContactNathawut Sibmooh

Chakri Naruebodindra Medical Institute, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Thailand

nathawut.sib@mahidol.ac.th028395204

Outcome results

None listed

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