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Completed

NCT Number: NCT03696758

Improving Right Ventricular Function in Young Adults Born Preterm

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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Key information

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Wisconsin-Madison School of Medicine and Public Health

Madison, Wisconsin, 53792, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 <1500 g)
  • Non-NLP participant, with birth weight <1500 g and gestational age 32 weeks or less, verified by medical records

Exclusion criteria

  • Pregnant or lactating
  • Use of prescribed medications that would interfere with study medications
  • Sildenafil: Use of phosphodiesterase type 5 inhibitors (sildenafil, tadalafil, vardenafil), nitrates, soluble guanylate cyclase inhibitor (riociguat) within 48 hours of study visit
  • Metoprolol: Use of nodal blocking agents including beta blockers, non-dihydropyridine calcium channel blockers (i.e. diltiazem), and anti-arrhythmics (i.e. amiodarone)
  • Presence of known comorbidities for which these therapeutic interventions would be contraindicated:
  • Moderate to severe heart failure
  • Severe bradycardia (heart rate <45), or second or third-degree heart block
  • Systolic blood pressure <90 mmHg or >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.

Treatment and study plan

Pulmonary Function Testing

Procedure

Subjects will undergo spirometry, Plethysmography, and diffusion capacity.

Electrocardiogram

Procedure

Subjects will undergo an electrocardiogram to ensure sinus rhythm

Cardiac Magnetic Resonance Imaging

Procedure

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

metoprolol

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.

Other names: Lopressor, Metolar XR

Sildenafil

Drug

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

Other names: Revatio

Primary outcomes

  1. Right Ventricular Energetic Efficiency Pre and Post Metoprolol

    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.

  2. Right Ventricular Energetic Efficiency Pre and Post Sildenafil

    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.

Secondary outcomes

  1. Left Ventricular Energetic Efficiency Pre and Post Metoprolol

    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.

  2. Right Ventricular Ejection Fraction Pre and Post Metoprolol

    Time frame: up to 2 hours

    Participants will receive intravenous metoprolol in between scans.

  3. Right Ventricular Stroke Volume Pre and Post Metoprolol

    Time frame: up to 2 hours

    Participants will receive intravenous metoprolol in between scans.

  4. Right Ventricular Systolic Volume Pre and Post Metoprolol

    Time frame: up to 2 hours

    Participants will receive intravenous metoprolol in between scans.

  5. Right Ventricular Diastolic Volume Pre and Post Metoprolol

    Time frame: up to 2 hours

    Participants will receive intravenous metoprolol in between scans.

  6. Left Ventricular Ejection Fraction Pre and Post Metoprolol

    Time frame: up to 2 hours

    Participants will receive intravenous metoprolol in between scans.

  7. Left Ventricular Stroke Volume Pre and Post Metoprolol

    Time frame: up to 2 hours

    Participants will receive intravenous metoprolol in between scans.

  8. Left Ventricular Systolic Volume Pre and Post Metoprolol

    Time frame: up to 2 hours

    Participants will receive intravenous metoprolol in between scans.

  9. Left Ventricular Diastolic Volume Pre and Post Metoprolol

    Time frame: up to 2 hours

    Participants will receive intravenous metoprolol in between scans.

  10. Left Ventricular Energetic Efficiency Pre and Post Sildenafil

    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.

  11. Right Ventricular Ejection Fraction Pre and Post Sildenafil

    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.

  12. Right Ventricular Stroke Volume Pre and Post Sildenafil

    Time frame: up to 2 hours

    Participants will be given sildenafil in between imaging scans.

  13. Right Ventricular Systolic Volume Pre and Post Sildenafil

    Time frame: up to 2 hours

    Participants will be given sildenafil in between imaging scans.

  14. Right Ventricular Diastolic Volume Pre and Post Sildenafil

    Time frame: up to 2 hours

    Participants will be given sildenafil in between imaging scans.

  15. Left Ventricular Ejection Fraction Pre and Post Sildenafil

    Time frame: up to 2 hours

    Participants will be given sildenafil in between imaging scans.

  16. Left Ventricular Stroke Volume Pre and Post Sildenafil

    Time frame: up to 2 hours

    Participants will be given sildenafil in between imaging scans.

  17. Left Ventricular Systolic Volume Pre and Post Sildenafil

    Time frame: up to 2 hours

    Participants will be given sildenafil in between imaging scans.

  18. Left Ventricular Diastolic Volume Pre and Post Sildenafil

    Time frame: up to 2 hours

    Participants will be given sildenafil in between imaging scans.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • National Center for Advancing Translational Sciences (NCATS)

Registry information

Official study title

Improving Right Ventricular Function in Young Adults Born Preterm: A Pilot Study

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Oct 5, 2018
Registry last updated
Mar 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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