Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:21 AM
Ignite Modification Date:
2025-12-25 @ 12:21 AM
NCT ID:
NCT03696758
Eligibility Criteria:
Inclusion Criteria:
1. Provision of signed and dated informed consent form
2. Male or female aged 18-35
3. History of preterm birth (either a or b):
1. Participant in the Newborn Lung Project (birth year 1988-1991, birth weight \<1500 g)
2. Non-NLP participant, with birth weight \<1500 g and gestational age 32 weeks or less, verified by medical records
Exclusion Criteria:
1. Pregnant or lactating
2. Use of prescribed medications that would interfere with study medications
1. Sildenafil: Use of phosphodiesterase type 5 inhibitors (sildenafil, tadalafil, vardenafil), nitrates, soluble guanylate cyclase inhibitor (riociguat) within 48 hours of study visit
2. Metoprolol: Use of nodal blocking agents including beta blockers, non-dihydropyridine calcium channel blockers (i.e. diltiazem), and anti-arrhythmics (i.e. amiodarone)
3. Presence of known comorbidities for which these therapeutic interventions would be contraindicated:
1. Moderate to severe heart failure
2. Severe bradycardia (heart rate \<45), or second or third-degree heart block
3. Systolic blood pressure \<90 mmHg or \>190 mmHg
4. Angina
5. Severe peripheral arterial circulatory disorders
6. History of severe bronchospasm
4. Presence of any implanted device incompatible with CMR imaging
5. Known allergic or hypersensitivity reaction to components of the study medications
6. Any other reason for which the investigator deems a subject unsafe or inappropriate for study participation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
35 Years
Study:
NCT03696758
Study Brief:
Protocol Section:
NCT03696758