Overview
Sponsor-declared trial summary
Pulmonary Hypertension
To objectify the effect of high-concentration (100%) oxygen suppletion on coronary, pulmonary and systemic haemodynamics, and the chronological sequence of these effects
Key facts
- Sponsor
- Stichting Radboud universitair medisch centrum
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Respiratory Tract Diseases [C08], Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutics [E02], Diseases [C] - Cardiovascular Diseases [C14], Phenomena and Processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
- Decision date (initial)
- 2024-10-31
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
To objectify the effect of high-concentration (100%) oxygen suppletion on coronary, pulmonary and systemic haemodynamics, and the chronological sequence of these effects
Conditions and MedDRA coding
Pulmonary Hypertension
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Subject ≥18 years of age
- Subject planned for clinically indicated: 1. CFT demonstrating microvascular dysfunction; or 2. RHC (and LHC) for suspected PH; or 3. RHC (and LHC) as a part of HTx or LVAD screening
- No obstructive coronary artery disease (defined as ≤50% visual stenosis and/or negative FFR/iFR/RFR)
- Able and willing to provide informed consent
Exclusion criteria 8
- Estimated glomerular filtration rate of <30ml/min
- Known history of chronic obstructive pulmonary disease GOLD IV
- Known moderate and severe valvular disease
- Clinically indicated treatment with oxygen
- Pacemaker in situ
- Active pregnancy
- Contrast allergy
- Complications during clinically indicated invasive heart catheterization
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- CO (l/min) at 10 minutes after the start of each intervention
Secondary endpoints 4
- CO (l/min) at baseline and after 5 minutes of each intervention
- Q (ml/min), R (Woods Units), PAWP (mmHg), PVR (mmHg/l/min) and SVR (mmHg/l/min) at baseline and 5 and 10 minutes after each intervention
- Epicardial and microvascular vasospasm at 10 minutes after the start of each intervention
- Chronological order of changes in CO, Q, R, PAWP, PVR and SVR
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Conoxia® Vloeibaar, 100% v/v, medicinaal gas, cryogeen
PRD404300 · Product
- Active substance
- Oxygen
- Pharmaceutical form
- MEDICINAL GAS, CRYOGENIC
- Route of administration
- ORAL
- Max daily dose
- 14400 l litre(s)
- Max total dose
- 14400 l litre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- V03AN01 — -
- Marketing authorisation
- RVG 100211
- MA holder
- LINDE GAS THERAPEUTICS BENELUX BV
- MA country
- Netherlands
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Stichting Radboud universitair medisch centrum
- Sponsor organisation
- Stichting Radboud universitair medisch centrum
- Address
- Geert Grooteplein Zuid 10
- City
- Nijmegen
- Postcode
- 6525 GA
- Country
- Netherlands
Scientific contact point
- Organisation
- Stichting Radboud universitair medisch centrum
- Contact name
- Roland
Public contact point
- Organisation
- Stichting Radboud universitair medisch centrum
- Contact name
- Roland
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Authorised, recruitment pending | 24 | 1 |
| 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 8 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_ Protocol 2024-516279-34-00_redacted | 2.0 |
| Recruitment arrangements (for publication) | K1_ Recruitment procedure | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF CFT_redacted | 3 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF LHC_RHC _redacted | 3 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF RHC _redacted | 3 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_ SmPC Oxygen | 1 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_EN 2024-516279-34-00 | 1 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_NL 2024-516279-34-00 | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-18 | Netherlands | Acceptable 2024-10-31
|
2024-10-31 |