Phase 2 N=9 Randomized Single-blind Treatment

Improving Right Ventricular Function in Young Adults Born Preterm

Infant,Premature

Bottom Line

View on ClinicalTrials.gov: NCT03696758 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2021

Primary outcome: Primary: Right Ventricular Energetic Efficiency Pre and Post Metoprolol — 15.5; 12.7 µJ/ml — p=0.004

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Pulmonary Function Testing (Procedure); Electrocardiogram (Procedure); Cardiac Magnetic Resonance Imaging (Procedure); Metoprolol (Drug); Sildenafil (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: University of Wisconsin, Madison
Primary completion: Feb 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Right Ventricular Energetic Efficiency Pre and Post Metoprolol	15.5; 12.7	0.004 sig
PRIMARY Right Ventricular Energetic Efficiency Pre and Post Sildenafil	15.8; 17.9	0.13
SECONDARY Left Ventricular Energetic Efficiency Pre and Post Metoprolol	11.6; 9.5	0.004 sig
SECONDARY Right Ventricular Ejection Fraction Pre and Post Metoprolol	55; 51	0.1
SECONDARY Right Ventricular Stroke Volume Pre and Post Metoprolol	41.5; 37.7	0.09
SECONDARY Right Ventricular Systolic Volume Pre and Post Metoprolol	33.7; 36.6	0.10
SECONDARY Right Ventricular Diastolic Volume Pre and Post Metoprolol	75.2; 74.4	0.82
SECONDARY Left Ventricular Ejection Fraction Pre and Post Metoprolol	60; 58	0.30
SECONDARY Left Ventricular Stroke Volume Pre and Post Metoprolol	43.7; 41.4	0.36
SECONDARY Left Ventricular Systolic Volume Pre and Post Metoprolol	28.8; 30.6	0.36
SECONDARY Left Ventricular Diastolic Volume Pre and Post Metoprolol	72.5; 72.1	0.65
SECONDARY Left Ventricular Energetic Efficiency Pre and Post Sildenafil	11.1; 12.3	0.25
SECONDARY Right Ventricular Ejection Fraction Pre and Post Sildenafil	53; 55	0.43
SECONDARY Right Ventricular Stroke Volume Pre and Post Sildenafil	40.4; 41.3	0.66
SECONDARY Right Ventricular Systolic Volume Pre and Post Sildenafil	35.8; 33.3	0.13
SECONDARY Right Ventricular Diastolic Volume Pre and Post Sildenafil	76.2; 74.6	0.57
SECONDARY Left Ventricular Ejection Fraction Pre and Post Sildenafil	60; 63	0.25
SECONDARY Left Ventricular Stroke Volume Pre and Post Sildenafil	43.1; 45.7	0.07
SECONDARY Left Ventricular Systolic Volume Pre and Post Sildenafil	28.1; 26.6	0.36
SECONDARY Left Ventricular Diastolic Volume Pre and Post Sildenafil	71.2; 72.2	0.91

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.

Eligibility Criteria

Inclusion Criteria

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 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03696758). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.