Clinical trial • Phase IV • Respiratory | Cardiology | Other

OXYGEN for Pulmonary hypertension | Coronary microvascular dysfunction | Hypoxia | Heart failure

Phase IV trial of OXYGEN for Pulmonary hypertension | Coronary microvascular dysfunction | Hypoxia | Heart failure. open-label. 24 participants.

Overview

Trial Therapeutic Area: Respiratory | Cardiology | Other
Trial Disease: Pulmonary hypertension | Coronary microvascular dysfunction | Hypoxia | Heart failure
Trial Stage: Phase IV
Drug Modality: Small molecule

open-label Phase IV trial across 1 site in Netherlands.

Recruits 24 No vulnerable population selected. Adults only (Subject ≥18 years of age). Informed consent required from participant..

Pregnancy Exclusion: Active pregnancy
Vulnerable Population: No vulnerable population selected. Adults only (Subject ≥18 years of age). Informed consent required from participant.

{"criterion_text":"- Subject ≥18 years of age"}
{"criterion_text":"- 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"}
{"criterion_text":"- No obstructive coronary artery disease (defined as ≤50% visual stenosis and/or negative FFR/iFR/RFR)"}
{"criterion_text":"- Able and willing to provide informed consent"}

{"criterion_text":"- Estimated glomerular filtration rate of <30ml/min"}
{"criterion_text":"- Known history of chronic obstructive pulmonary disease GOLD IV"}
{"criterion_text":"- Known moderate and severe valvular disease"}
{"criterion_text":"- Clinically indicated treatment with oxygen"}
{"criterion_text":"- Pacemaker in situ"}
{"criterion_text":"- Active pregnancy"}
{"criterion_text":"- Contrast allergy"}
{"criterion_text":"- Complications during clinically indicated invasive heart catheterization"}

{"endpoint_text":"- CO (l/min) at 10 minutes after the start of each intervention","definition_or_measurement_approach":"CO (l/min) measured at 10 minutes after the start of each intervention (measurement method not specified in the provided record)"}

{"endpoint_text":"- CO (l/min) at baseline and after 5 minutes of each intervention","definition_or_measurement_approach":"CO (l/min) measured at baseline and after 5 minutes of each intervention (measurement method not specified in the provided record)"}
{"endpoint_text":"- 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","definition_or_measurement_approach":"Measurements of Q, R, PAWP, PVR and SVR at baseline and at 5 and 10 minutes after each intervention (specific measurement techniques not specified in the provided record)"}
{"endpoint_text":"- Epicardial and microvascular vasospasm at 10 minutes after the start of each intervention","definition_or_measurement_approach":"Assessment of epicardial and microvascular vasospasm at 10 minutes after start of each intervention (method not specified in the provided record)"}
{"endpoint_text":"- Chronological order of changes in CO, Q, R, PAWP, PVR and SVR","definition_or_measurement_approach":"Temporal sequencing analysis of changes in listed haemodynamic parameters (specific analysis method not specified in the provided record)"}

Planned Sample Size: 24
Recruitment Window Months: 12
Consent Approach: Informed consent required from participant (able and willing to provide informed consent). Adults only (≥18 years). Subject information and informed consent form documents are listed in the trial record.

Investigational Product Name: Conoxia® Vloeibaar, 100% v/v, medicinaal gas, cryogeen
Active Substance: OXYGEN
Modality: Small molecule
Routes Of Administration: ORAL
Route: ORAL
Authorisation Status: Authorised (marketing authorisation RVG 100211 in NL)
Maximum Dose: 14400 l

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