University of Wisconsin-Madison School of Medicine and Public Health
Madison, Wisconsin, 53792, United States
NCT Number: NCT03696758
The purpose of this research is to evaluate the short-term effects of sildenafil and metoprolol on heart function in young adults born premature.
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Notify Me18 year–35 year
All sexes
Interventional
Phase 2
Madison, Wisconsin, 53792, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Subjects will undergo spirometry, Plethysmography, and diffusion capacity.
Subjects will undergo an electrocardiogram to ensure sinus rhythm
Subjects will undergo positron magnetic resonance imaging to detect images of the heart
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.
Other names: Lopressor, Metolar XR
Subjects will receive a 50 milligram tablet of sildenafil (to be taken orally)
Other names: Revatio
Time frame: up to 2 hours
To characterize energy efficiency, the total Kinetic Energy across the cardiac cycle is normalized to right ventricular end-diastolic volume and left ventricular end-diastolic volume, respectively. Analysis will be completed in blinded fashion. Two imaging scans will be done - one pre and one post Metoprolol intervention. Total time from Pre-intervention scan till post intervention scan may take up to 2 hours.
Time frame: up to 2 hours
To characterize energy efficiency, the total Kinetic Energy across the cardiac cycle is normalized to right ventricular end-diastolic volume and left ventricular end-diastolic volume, respectively. Analysis will be completed in blinded fashion. Two imaging scans will be done - one pre and one post Sildenafil intervention. Total time from Pre-intervention scan till post intervention scan may take up to 2 hours.
Time frame: up to 2 hours
Kinetic energy (from 4D flow) normalized to ventricular volume (from MRI). Participants will receive intravenous metoprolol in between scans.
Time frame: up to 2 hours
Participants will receive intravenous metoprolol in between scans.
Time frame: up to 2 hours
Participants will receive intravenous metoprolol in between scans.
Time frame: up to 2 hours
Participants will receive intravenous metoprolol in between scans.
Time frame: up to 2 hours
Participants will receive intravenous metoprolol in between scans.
Time frame: up to 2 hours
Participants will receive intravenous metoprolol in between scans.
Time frame: up to 2 hours
Participants will receive intravenous metoprolol in between scans.
Time frame: up to 2 hours
Participants will receive intravenous metoprolol in between scans.
Time frame: up to 2 hours
Participants will receive intravenous metoprolol in between scans.
Time frame: up to 2 hours
Kinetic energy (from 4D flow) normalized to ventricular volume (from MRI). Participants will be given sildenafil in between imaging scans.
Time frame: up to 2 hours
Participants will be given sildenafil in between imaging scans. The term "ejection fraction" refers to the percentage of blood that's pumped out of a filled ventricle with each heartbeat.
Time frame: up to 2 hours
Participants will be given sildenafil in between imaging scans.
Time frame: up to 2 hours
Participants will be given sildenafil in between imaging scans.
Time frame: up to 2 hours
Participants will be given sildenafil in between imaging scans.
Time frame: up to 2 hours
Participants will be given sildenafil in between imaging scans.
Time frame: up to 2 hours
Participants will be given sildenafil in between imaging scans.
Time frame: up to 2 hours
Participants will be given sildenafil in between imaging scans.
Time frame: up to 2 hours
Participants will be given sildenafil in between imaging scans.
University of Wisconsin, Madison
Other
Improving Right Ventricular Function in Young Adults Born Preterm: A Pilot Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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