Trial Outcomes & Findings for Improving Right Ventricular Function in Young Adults Born Preterm (NCT NCT03696758)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

10 participants

Primary outcome timeframe

up to 2 hours

Results posted on

2021-03-17

Participant Flow

Due to COVID shut down, 1 participant was excluded from the study before assignment to groups

Participant milestones

Participant milestones
Measure	Sildenafil Followed by Metoprolol 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 next visit. There will be a minimum period of 12 hours between drug interventions to ensure adequate drug wash-out. Subjects will also undergo pulmonary function testing and electrocardiogram.	Metoprolol Followed by Sildenafil 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 metoprolol in between imaging scans at one visit, and will receive intravenous sildenafil in between scans at next visit. There will be a minimum period of 12 hours between drug interventions to ensure adequate drug wash-out. Subjects will also undergo pulmonary function testing and electrocardiogram.
First Intervention STARTED	3	6
First Intervention COMPLETED	3	6
First Intervention NOT COMPLETED	0	0
Wash Out>12 Hours STARTED	3	6
Wash Out>12 Hours COMPLETED	3	6
Wash Out>12 Hours NOT COMPLETED	0	0
Second Intervention STARTED	3	6
Second Intervention COMPLETED	3	6
Second Intervention NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Improving Right Ventricular Function in Young Adults Born Preterm

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Young Adults Born Premature n=9 Participants 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. Subjects will also undergo pulmonary function testing and electrocardiogram. Pulmonary Function Testing: Subjects will undergo spirometry, Plethysmography, and diffusion capacity. Electrocardiogram: Subjects will undergo an electrocardiogram to ensure sinus rhythm Cardiac Magnetic Resonance Imaging: Subjects will undergo positron magnetic resonance imaging to detect images of the heart Metoprolol: Subjects will receive intravenous metoprolol Sildenafil: Subjects will receive a 50 milligram tablet of sildenafil (to be taken orally)
Age, Continuous	27.8 Years STANDARD_DEVIATION 3.7 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	9 participants n=5 Participants
Gestational age (Neonatal Characteristics)	28.9 Weeks STANDARD_DEVIATION 2.7 • n=5 Participants
Birth weight (Neonatal Characteristics)	1116 gram STANDARD_DEVIATION 342 • n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Young Adults Born Premature n=9 Participants 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. Subjects will also undergo pulmonary function testing and electrocardiogram. Pulmonary Function Testing: Subjects will undergo spirometry, Plethysmography, and diffusion capacity. Electrocardiogram: Subjects will undergo an electrocardiogram to ensure sinus rhythm Cardiac Magnetic Resonance Imaging: Subjects will undergo positron magnetic resonance imaging to detect images of the heart Metoprolol: Subjects will receive intravenous metoprolol Sildenafil: Subjects will receive a 50 milligram tablet of sildenafil (to be taken orally)
Right Ventricular Energetic Efficiency Pre and Post Metoprolol Pre Metoprolol	15.5 µJ/ml Standard Deviation 2.6
Right Ventricular Energetic Efficiency Pre and Post Metoprolol Post Metoprolol	12.7 µJ/ml Standard Deviation 2.5

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Young Adults Born Premature n=9 Participants 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. Subjects will also undergo pulmonary function testing and electrocardiogram. Pulmonary Function Testing: Subjects will undergo spirometry, Plethysmography, and diffusion capacity. Electrocardiogram: Subjects will undergo an electrocardiogram to ensure sinus rhythm Cardiac Magnetic Resonance Imaging: Subjects will undergo positron magnetic resonance imaging to detect images of the heart Metoprolol: Subjects will receive intravenous metoprolol Sildenafil: Subjects will receive a 50 milligram tablet of sildenafil (to be taken orally)
Right Ventricular Energetic Efficiency Pre and Post Sildenafil Pre-Sildenafil	15.8 µJ/ml Standard Deviation 3.7
Right Ventricular Energetic Efficiency Pre and Post Sildenafil Post-Sildenafil	17.9 µJ/ml Standard Deviation 6.2

SECONDARY outcome

Timeframe: up to 2 hours

Kinetic energy (from 4D flow) normalized to ventricular volume (from MRI). Participants will receive intravenous metoprolol in between scans.