Improving Right Ventricular Function in Young Adults Born Preterm

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-30

Study Completion Date

2020-02-24

Brief Summary

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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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Detailed Description

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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

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Infant,Premature

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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. There will be a minimum period of 12 hours between drug interventions to ensure adequate drug wash-out.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Pulmonary Function Testing

Intervention Type PROCEDURE

Subjects will undergo spirometry, Plethysmography, and diffusion capacity.

Electrocardiogram

Intervention Type PROCEDURE

Subjects will undergo an electrocardiogram to ensure sinus rhythm

Cardiac Magnetic Resonance Imaging

Intervention Type PROCEDURE

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

Metoprolol

Intervention Type DRUG

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.

Sildenafil

Intervention Type DRUG

Subjects will receive a 50 milligram tablet of sildenafil (to be taken orally)

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.

Group Type EXPERIMENTAL

Pulmonary Function Testing

Intervention Type PROCEDURE

Subjects will undergo spirometry, Plethysmography, and diffusion capacity.

Electrocardiogram

Intervention Type PROCEDURE

Subjects will undergo an electrocardiogram to ensure sinus rhythm

Cardiac Magnetic Resonance Imaging

Intervention Type PROCEDURE

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

Metoprolol

Intervention Type DRUG

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.

Sildenafil

Intervention Type DRUG

Subjects will receive a 50 milligram tablet of sildenafil (to be taken orally)

Interventions

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Pulmonary Function Testing

Subjects will undergo spirometry, Plethysmography, and diffusion capacity.

Intervention Type PROCEDURE

Electrocardiogram

Subjects will undergo an electrocardiogram to ensure sinus rhythm

Intervention Type PROCEDURE

Cardiac Magnetic Resonance Imaging

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

Intervention Type PROCEDURE

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.

Intervention Type DRUG

Sildenafil

Subjects will receive a 50 milligram tablet of sildenafil (to be taken orally)

Intervention Type DRUG

Other Intervention Names

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Lopressor Metolar XR Revatio

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No