NCT03696758

Improving Right Ventricular Function in Young Adults Born Preterm

Improving Right Ventricular Function in Young Adults Born Preterm: A Pilot Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: All
• Age: 18 Years – 35 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Infant,Premature

Interventions

Type	Name	Description
PROCEDURE	Pulmonary Function Testing	Subjects will undergo spirometry, Plethysmography, and diffusion capacity.
PROCEDURE	Electrocardiogram	Subjects will undergo an electrocardiogram to ensure sinus rhythm
PROCEDURE	Cardiac Magnetic Resonance Imaging	Subjects will undergo positron magnetic resonance imaging to detect images of the heart
DRUG	Metoprolol	Subjects will receive intravenous metoprolol. Dose titrated 1-5 mg every 2 minutes to achieve goal heart rate of 55-65 beats per minute, or for subjects with a resting heart rate already at goal, titrated to achieve a 10-15% reduction in heart rate.
DRUG	Sildenafil	Subjects will receive a 50 milligram tablet of sildenafil (to be taken orally)

Timeline

• Start date: 2018-10-30
• Primary completion: 2020-02-24
• Completion: 2020-02-24
• First posted: 2018-10-05
• Last updated: 2021-03-17
• Results posted: 2021-02-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study