A Study to Evaluate the Efficacy, Safety and Tolerability of PDNO Infusion in Patients With Pulmo… (NCT05699486) | Clinical Trial Compass
UnknownPhase 2
A Study to Evaluate the Efficacy, Safety and Tolerability of PDNO Infusion in Patients With Pulmonary Hypertension After Cardiopulmonary Bypass Surgery
Sweden12 participantsStarted 2022-10-23
Plain-language summary
This is an open-label, multicenter study evaluating the dose, effect, safety and tolerability of intravenous PDNO infusion given to patients undergoing cardiopulmonary bypass (CPB) surgery with post-operative acute pulmonary hypertension (aPH).
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Ability to understand and willing to sign an informed consent form (ICF)
* Male and female patients, age ≥ 18 years
* Planned to undergo elective cardiopulmonary bypass (CPB) for coronary artery bypass grafting (CABG), aortic valve repair (AVR) or mitral valve repair (MVR) with or without CABG
* Diagnosed with echocardiographic signs of pulmonary artery systolic pressure (PASP) \>50 mmHg , as estimated by doppler defined echocardiography using a modified Bernoulli equation: PASP ≈ 4 (tricuspid regurgitant jet velocity)\^2 + central venous pressure (CVP)
Exclusion Criteria:
* History of chronic pulmonary hypertension (PH) (WHO group 1, 3, 4 or 5), not group 2 due to left heart disease
* Patients with contraindications for pulmonary artery catheter (PAC)
* History of severe chronic obstructive pulmonary disease
* Left heart failure with ejection fraction (EF) \<35%
* Non-ST elevation myocardial infarction (non-STEMI) or ST elevation myocardial infarction (STEMI) within 1 months prior to informed consent
* Stroke (cerebrovascular lesion \[CVL\]), transient ischemic attack (TIA), AV block III within 3 months prior to informed consent or QTcF \>450ms at the time of screening
* High inotropic requirement (no more than one inotrope treatment and the vasopressor norepinephrine at time of screening/postoperative evaluation)
* (Increased) mediastinal bleeding \>100 mL/hour in mediastinal drainage at postoperative evaluation
* Mechanical circulatory assistance (…
What they're measuring
1
Mean change in pulmonary vascular resistance (PVR)
Timeframe: From baseline (mean of -15 minutes and 0 minutes) to time point 15, 30, 45, 60, and 75 minutes with PDNO, respectively; and 85 and 95 minutes with placebo.