Clinical trial NCT03696758: Improving Right Ventricular Function in Young Adults Born Preterm
Official title: Improving Right Ventricular Function in Young Adults Born Preterm: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Infant,Premature
Keywords: premature adults
premature
premature cardiac function
MRI
sildenafil
metoprolol
CMR
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2018-10-05
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Young adults born premature, recruited either from the National Lung Project Cohort or the general public, will undergo Cardiac Magnetic Resonance Imaging before and after medication administration. This will occur twice, on two separate visits. Subjects will be given sildenafil in between imaging scans at one visit, and will receive intravenous metoprolol in between scans at a separate visit. These visits can occur in either order. There will be a minimum period of 12 hours between drug interventions to ensure adequate drug wash-out.
Primary purpose: TREATMENT

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

Detailed description: The purpose of this study is to evaluate the short-term therapeutic effects of sildenafil and metoprolol on right ventricular function in young adults born premature using novel 4-Dimensional flow Cardiac Magnetic Resonance Imaging.

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.

Primary outcomes:
measure: Right Ventricular Energetic Efficiency Pre and Post Metoprolol
timeFrame: up to 2 hours
measure: Right Ventricular Energetic Efficiency Pre and Post Sildenafil
timeFrame: up to 2 hours
Secondary outcomes:
measure: Left Ventricular Energetic Efficiency Pre and Post Metoprolol
timeFrame: up to 2 hours
measure: Right Ventricular Ejection Fraction Pre and Post Metoprolol
timeFrame: up to 2 hours
measure: Right Ventricular Stroke Volume Pre and Post Metoprolol
timeFrame: up to 2 hours
measure: Right Ventricular Systolic Volume Pre and Post Metoprolol
timeFrame: up to 2 hours
measure: Right Ventricular Diastolic Volume Pre and Post Metoprolol
timeFrame: up to 2 hours
measure: Left Ventricular Ejection Fraction Pre and Post Metoprolol
timeFrame: up to 2 hours
measure: Left Ventricular Stroke Volume Pre and Post Metoprolol
timeFrame: up to 2 hours
measure: Left Ventricular Systolic Volume Pre and Post Metoprolol
timeFrame: up to 2 hours
measure: Left Ventricular Diastolic Volume Pre and Post Metoprolol
timeFrame: up to 2 hours
measure: Left Ventricular Energetic Efficiency Pre and Post Sildenafil
timeFrame: up to 2 hours
measure: Right Ventricular Ejection Fraction Pre and Post Sildenafil
timeFrame: up to 2 hours
measure: Right Ventricular Stroke Volume Pre and Post Sildenafil
timeFrame: up to 2 hours
measure: Right Ventricular Systolic Volume Pre and Post Sildenafil
timeFrame: up to 2 hours
measure: Right Ventricular Diastolic Volume Pre and Post Sildenafil
timeFrame: up to 2 hours
measure: Left Ventricular Ejection Fraction Pre and Post Sildenafil
timeFrame: up to 2 hours
measure: Left Ventricular Stroke Volume Pre and Post Sildenafil
timeFrame: up to 2 hours
measure: Left Ventricular Systolic Volume Pre and Post Sildenafil
timeFrame: up to 2 hours
measure: Left Ventricular Diastolic Volume Pre and Post Sildenafil
timeFrame: up to 2 hours
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin-Madison School of Medicine and Public Health
state: Wisconsin
Study officials:
affiliation: University of Wisconsin-Madison School of Medicine and Public Health
name: Kara N Goss, MD
role: PRINCIPAL_INVESTIGATOR
References: