Improving Right Ventricular Function in Young Adults Born Preterm

University of Wisconsin, Madison10 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Infant,Premature

Interventions

Pulmonary Function TestingPROCEDURE

Subjects will undergo spirometry, Plethysmography, and diffusion capacity.

ElectrocardiogramPROCEDURE

Subjects will undergo an electrocardiogram to ensure sinus rhythm

Cardiac Magnetic Resonance ImagingPROCEDURE

Subjects will undergo positron magnetic resonance imaging to detect images of the heart

Eligibility

Sex: ALLMin age: 18 YearsMax age: 35 Years

Medical Language ↔ Plain English

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.

Locations (1)

University of Wisconsin-Madison School of Medicine and Public Health

Madison, Wisconsin, United States

Outcomes

Primary Outcomes

Right Ventricular Energetic Efficiency Pre and Post Metoprolol

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

Right Ventricular Energetic Efficiency Pre and Post Sildenafil

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

Secondary Outcomes

Left Ventricular Energetic Efficiency Pre and Post Metoprolol

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

Right Ventricular Ejection Fraction Pre and Post Metoprolol

Participants will receive intravenous metoprolol in between scans.

Time frame: up to 2 hours

Right Ventricular Stroke Volume Pre and Post Metoprolol

Participants will receive intravenous metoprolol in between scans.

Time frame: up to 2 hours

Right Ventricular Systolic Volume Pre and Post Metoprolol

Data from ClinicalTrials.gov

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