Overview
Sponsor-declared trial summary
Patients in the immediate cardiac surgery post-operative period
To study the effects of inhaled iNO on pulmonary vascular mechanics, right ventricular function, and right ventricular-vascular coupling in patients in the immediate cardiac surgery post-operative period
Key facts
- Sponsor
- Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Princesa
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutics [E02]
- Decision date (initial)
- 2025-01-24
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2025-520808-10-00
- EudraCT number
- 2022-003884-37
- ClinicalTrials.gov
- NCT06097026
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Therapy
To study the effects of inhaled iNO on pulmonary vascular mechanics, right ventricular function, and right ventricular-vascular coupling in patients in the immediate cardiac surgery post-operative period
Secondary objectives 2
- To evaluate the synergistic effects of iNO with a lung recruitment maneuver, on pulmonary vascular mechanics, right ventricular function, and right ventricular-vascular coupling in the immediate post-operative period after cardiac surgery
- To study patterns of pulmonary blood flow redistribution measured by EIT predictive of a positive effect on vascular mechanics and right ventricular function
Conditions and MedDRA coding
Patients in the immediate cardiac surgery post-operative period
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 7
- Obtained informed consent
- Age > 18 years
- Under passive mechanical ventilation
- Pre-operative FEVI ≥ 30%
- Absence of hypovolemia: absence of ventricular "kissing" and / or superior vena cava collapsibility index < 20%
- Stable spontaneous heart rythm
- Post-operative hemodynamic stability
Exclusion criteria 7
- Cor pulmonale or presence of preoperative pulmonary vascular pathology
- Chronic pulmonary hypertension (mPAP> 35 mmHg) related to advanced COPD or chronic thromboembolic disease
- Surgery involving the tricuspid or pulmonary valves
- Intra- or post-operative use of nitroprusside or nitroglycerine
- Pre-operative dependence of inotropic drugs or vasoconstrictors
- Use of levosimendan. If dobutamine is in use, patients can be included provided the infusion can be stopped or is ≤ 1 µg/kg/min
- Pacemaker dependency
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Parameters of right ventricular function
Secondary endpoints 1
- Results of the electrical impedance tomography (EIT): regional distribution of ventilation and perfusion and EIT pulsatility
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
VasoKINOX 800 ppm mol/mol, gas comprimido medicinal
PRD5069462 · Product
- Active substance
- Nitric Oxide
- Pharmaceutical form
- MEDICINAL GAS, COMPRESSED
- Route of administration
- INHALATION GAS
- Max daily dose
- 40 PPM part per million
- Max total dose
- 40 PPM part per million
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- R07AX01 — NITRIC OXIDE
- Marketing authorisation
- 82148
- MA holder
- AIR LIQUIDE SANTE INTERNATIONAL
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Princesa
- Sponsor organisation
- Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Princesa
- Address
- Calle De Diego De Leon 62
- City
- Madrid
- Postcode
- 28006
- Country
- Spain
Scientific contact point
- Organisation
- Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Princesa
- Contact name
- Isabel Magaña Bru
Public contact point
- Organisation
- Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Princesa
- Contact name
- Isabel Magaña Bru
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Authorised, recruitment pending | 50 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 4 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | PROTOCOLO RONIN - ENGLISH | 2 |
| Recruitment arrangements (for publication) | 0_Transition template | 1 |
| Subject information and informed consent form (for publication) | HIP RONIN-CCV_2_04_2023 | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | SPC_Vasokinox 800_032018 | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-01-24 | Spain | Acceptable 2025-01-24
|
2025-01-24 |