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A Prospective Exploratory Clinical Study Evaluating the Efficacy and Safety of the INOFlo System in Cases of Cardiogenic Shock Under Impella Support

A Prospective Exploratory Clinical Study Evaluating the Efficacy and Safety of the INOFlo System in Cases of Cardiogenic Shock Under Impella Support

Minatsuki shun

The University of Tokyo Hospital

7-3-1 Hongo. Bunkyo-ku,Tokyo

shunminatsuki@gmail.com

Kiriyama Hiroyuki

The University of Tokyo Hospital

7-3-1 Hongo. Bunkyo-ku,Tokyo

+81-338155411

kiriyaman0427@gmail.com

Recruiting

Mar. 09, 2026

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

(1) Individuals with cardiogenic shock under hemodynamic support with Impella.
(2) Individuals within 5 days of initiating Impella support and not yet introduced to nitric oxide therapy.
(3) Individuals with a pulmonary artery catheter inserted.
(4) Individuals with pulmonary hypertension (mean pulmonary artery pressure >= 21 mmHg and PVR >= 2 Wood units).
(5) Age: Individuals aged >= 18 years at the time of informed consent.
(6) Gender: Not specified.
(7) Individuals who have provided voluntary written informed consent (by themselves or a legal representative) after receiving sufficient explanation and achieving full understanding for participation in this study

(1) Individuals in whom ECMO or IMPELLA does not function stably due to factors other than right ventricular afterload.
(2) Individuals with persistent severe hypotension with mean arterial pressure < 50 mmHg even under ECPELLA support.
(3) Individuals with severe hepatic impairment, renal impairment, or cardiovascular disease (determined with reference to Grade 3 of JCOG CTCAE version 5.0).
(4) Individuals undergoing or requiring prohibited concomitant therapies.
(5) Others judged inappropriate for participation in this study by the investigator or sub-investigator.

Both

Cardiogenic shock

In cases using Impella, within 5 days of initiating Impella, inhalation of nitric oxide at a concentration of 20-40 ppm will be performed for 6 hours under room air using a nitric oxide delivery system (INOFlo DS) for research purposes

Nitric oxide delivery system (INOvent DS)

Change in Pulmonary Artery Pulsatility Index (PAPi) 6 hours after the start of inhaled nitric oxide (iNO) compared to baseline.

(1) Change in pulmonary hemodynamics (right atrial pressure, pulmonary artery pressure, pulmonary artery wedge pressure, cardiac output, pulmonary vascular resistance) 6 hours after the start of inhaled nitric oxide (iNO) compared to baseline.
(2) Change in systemic blood pressure 6 hours after the start of inhaled nitric oxide (iNO) compared to baseline.
(3) Change in SvO2 6 hours after the start of inhaled nitric oxide (iNO) compared to baseline.
(4) Change in IMPELLA flow 6 hours after the start of inhaled nitric oxide (iNO) compared to baseline.
(5) Change in P/F ratio 6 hours after the start of inhaled nitric oxide (iNO) compared to baseline.
(6) Change in dosage of vasopressors/inotropes 6 hours after the start of inhaled nitric oxide (iNO) compared to baseline.
(7) Incidence frequency of treatment-related adverse events (hypotension, pulmonary edema, methemoglobinemia) from the start of inhaled nitric oxide (iNO).
(8) Incidence frequency of adverse events.
(9) Incidence frequency of device malfunctions.

+81-358413600

Feb. 25, 2026

No

none