Improving Right Ventricular Function in Young Adults Born Preterm

Completed · Phase 2

Conditions studied: Infant,Premature

In brief

The purpose of this research is to evaluate the short-term effects of sildenafil and metoprolol on heart function in young adults born premature.

Key facts

Study ID

NCT03696758

Run by

University of Wisconsin, Madison

People needed

10

Starts

2018-10-30

Expected to finish

2020-02-24

Last updated by the study team

2021-03-17

Who can join

Age: 18 and older, up to 35. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Provision of signed and dated informed consent form
• Male or female aged 18-35
• History of preterm birth (either a or b):
• Participant in the Newborn Lung Project (birth year 1988-1991, birth weight <1500 g)
• Non-NLP participant, with birth weight <1500 g and gestational age 32 weeks or less, verified by medical records

You may not qualify if…

• Pregnant or lactating
• Use of prescribed medications that would interfere with study medications
• Sildenafil: Use of phosphodiesterase type 5 inhibitors (sildenafil, tadalafil, vardenafil), nitrates, soluble guanylate cyclase inhibitor (riociguat) within 48 hours of study visit
• Metoprolol: Use of nodal blocking agents including beta blockers, non-dihydropyridine calcium channel blockers (i.e. diltiazem), and anti-arrhythmics (i.e. amiodarone)
• Presence of known comorbidities for which these therapeutic interventions would be contraindicated:
• Moderate to severe heart failure
• Severe bradycardia (heart rate <45), or second or third-degree heart block
• Systolic blood pressure <90 mmHg or >190 mmHg
• Angina
• Severe peripheral arterial circulatory disorders
• History of severe bronchospasm
• Presence of any implanted device incompatible with CMR imaging
• Known allergic or hypersensitivity reaction to components of the study medications
• Any other reason for which the investigator deems a subject unsafe or inappropriate for study participation.

Where it is running

• University of Wisconsin-Madison School of Medicine and Public Health — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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