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

JRCT ID: jRCTs051230200

Registered date:12/03/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Mitral Regurgitation complicated with pulmonary hypertension
• Date of first enrollment: 12/03/2024
• Target sample size: 40
• Study type: Interventional
• Intervention(s): Protocol therapy consists of continuous inhalation of NO at a concentration of 20 ppm using INOflow DS until the day after TMVr surgery.

Outcome(s)

• Primary Outcome: Change in PVR from baseline to 1 day after TMVr

Secondary Outcome

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).

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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. Patients on catecholamines.
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.

Related Information

• Primary Sponsor: Matoba Satoaki
• Source(s) of Monetary Support: INO Therapeutic LLC