Effects of inhaled NO on hemodynamics after transcatheter mitral valve repair in patients with mitral regurgitation complicated with pulmonary hypertension

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs051230200

Enrollment

Registered

2024-03-12

Start date

2024-03-12

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Mitral Regurgitation complicated with pulmonary hypertension mitral regurgitation, Pulmonary Hypertension

Interventions

Protocol therapy consists of continuous inhalation of NO at a concentration of 20 ppm using INOflow DS until the day after TMVr surgery.

D009569

Nitric Oxide

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. TMVr is scheduled for mitral regurgitation. 2. Preoperative right heart catheterization reveals pulmonary hypertension (mPAP > 20 mmHg). 3. Patients aged 18 and older. 4. Patient's written consent has been obtained prior to enrollment.

Exclusion criteria

Exclusion criteria: 1. Patients with contraindications to inhaled NO (patients who is completely dependent on a right - left shunt). 2. Patients who are scheduled for treatment of valvelar disease other than mitral regurgitation. 3. Patients who are already receiving pulmonary vasodilators (phosphodiesterase 5 inhibitors, soluble guanylate cyclase stimulators, endothelin receptor antagonists, prostacyclin analogs, and prostacyclin receptor agonists). 4. The following concomitant medications are required to continue i) Sodium nitroprusside ii) Nitroglycerin iii) Sulfonamide 5. Patient who is receiving mechanical circulatory support such as aortic balloon pump, Impella left ventricular assist catheter, or percutaneous cardiopulmonary assist device for severe heart failure. 6. Current use of catecholamines. However, the use of dobutamine at a dose of up to 3 microgram/kg/min is allowed. 7. Patients who are a pregnant or lactating. 8. Patients who do not agree to contraception during participation in this study. 9. For other safety reasons, the investigator determines that the subject is not suitable to participate in this study.

Design outcomes

Primary

Measure	Time frame
Change in PVR from baseline to 1 day after TMVr	—

Secondary

Measure	Time frame
1. Change in CI from baseline to 1 day after TMVr. 2. Change in mPAP from baseline to 1 day after TMVr. 3. Change in pulmonary vascular resistance (PVR) from TMVr to 1 day after TMVr. 4. Complications (acute renal failure, reintubation, sepsis, cardiogenic shock, and urgent reoperation).	—

Contacts

Public ContactNaohiko Nakanishi

Kyoto Prefectural University of Medicine

naka-nao@koto.kpu-m.ac.jp+81-75-251-5511

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026