An open-label, multicenter study to evaluate the DOSE, efficacy, safety and tolerability of PDNO (Nitrosooxypropanol) infusion in patients with pulmonary hypertension after cardiopulmonary bypass (CPB) surgery for Coronary artery bypass grafting (CABG) or mitral or Aortic valve repair or replacement with or without CABG

Attgeno AB0 sites40 target enrollmentDecember 29, 2021

Overview

No summary available.

Registry

who.int

Start Date

December 29, 2021

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1\.Ability to understand and willing to sign an ICF after information at the pre\-op screening visit.
•2\.Male and female patients, age \= 18 years on the date of the informed consent at the time of the pre\-op screening visit.\*
•3\.Planned to undergo elective cardiopulmonary bypass (CPB) for CABG, AVR or MVR w
•or w/o CABG. Non\-elective (emergency) surgery patients are not eligible. Concomitant
•CryoMaze procedure and/or surgical left atrial appendix occlusion as a treatment for
•atrial fibrillation is routinely performed in some of these patients and may be done.
•4\.Diagnosed with echocardiographic signs of pulmonary artery systolic pressure (PASP) \=40 mmHg, as estimated by doppler defined echocardiography using a modified Bernoulli equation: PASP ˜ 4 (tricuspid regurgitant jet velocity)2 \+ CVP.
•\*evaluated from medical history
•Are the trial subjects under 18? no
•Number of subjects for this age range:

•Patients must not enter the study if any of the following exclusion criteria are fulfilled:
•1\.History of chronic PH (WHO group 1, 3, 4 or 5\), not group 2 due to left heart disease, as judged by the Investigator.\*
•2\.Patients with contraindications for PAC.
•3\.History of severe chronic obstructive pulmonary disease, as judged by the Investigator.\*
•4\.Left heart failure with ejection fraction (EF) \<35%.
•5\.Non\-ST elevation myocardial infarction \[non\-STEMI] or ST elevation myocardial infarction \[STEMI] within 1 months prior to informed consent.\*
•6\.Stroke (CVL), transient ischemic attack (TIA), AV block III within 3 months prior to informed consent or QTcF \>450ms at the time of screening.\*
•7\.High inotropic requirement (No more than one inotrope treatment and the vasopressor norepinephrine at time of screening/postoperative evaluation).
•8\.(Increased) mediastinal bleeding \>100 mL/hour in mediastinal drainage at postoperative evaluation.
•9\.Mechanical circulatory assistance (IABP or R/L VAD).