Infant,PrematurePhase 2NCT03696758

Improving Right Ventricular Function in Young Adults Born Preterm

A Phase 2 study testing Pulmonary Function Testing, Electrocardiogram and Cardiac Magnetic Resonance Imaging in people with Infant,Premature, run by University of Wisconsin, Madison at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 35 years
Conditions the study is for: Infant,Premature
What is being tested?: Pulmonary Function Testing, Electrocardiogram and Cardiac Magnetic Resonance Imaging
Type of treatment: Pill or oral medicine, Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 1 siteUnited States
Study dates: 30 Oct 2018to 24 Feb 2020
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 35 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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

Who cannot join

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

Show all 14Show fewer

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Wisconsin-Madison School of Medicine and Public Health
Madison, Wisconsin, 53792

Other trials in United States

About this study

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

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

Read the detailed description

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: Infant,Premature
Being tested: Pulmonary Function Testing, Electrocardiogram, Cardiac Magnetic Resonance Imaging, Metoprolol, Sildenafil
Keywords: premature adults, premature, premature cardiac function, MRI, sildenafil, metoprolol, CMR
Medical subject headings: Premature Birth

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Pulmonary Function TestingProcedure or surgery
Subjects will undergo spirometry, Plethysmography, and diffusion capacity.
ElectrocardiogramProcedure or surgery
Subjects will undergo an electrocardiogram to ensure sinus rhythm
Cardiac Magnetic Resonance ImagingProcedure or surgery
Subjects will undergo positron magnetic resonance imaging to detect images of the heart
MetoprololDrug
Also called Lopressor, Metolar XR
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.
SildenafilDrug
Also called Revatio
Subjects will receive a 50 milligram tablet of sildenafil (to be taken orally)

Study groups in NCT03696758
Study group	Role	What they receive
Sildenafil followed by Metoprolol	Experimental	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. Receives: Procedure: Pulmonary Function Testing; Procedure: Electrocardiogram; Procedure: Cardiac Magnetic Resonance Imaging; Drug: Metoprolol; Drug: Sildenafil
Metoprolol followed by Sildenafil	Experimental	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. Receives: Procedure: Pulmonary Function Testing; Procedure: Electrocardiogram; Procedure: Cardiac Magnetic Resonance Imaging; Drug: Metoprolol; Drug: Sildenafil

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: up to 2 hours

Secondary outcomes (18)

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.
Measured: up to 2 hours
Right Ventricular Ejection Fraction Pre and Post Metoprolol
Participants will receive intravenous metoprolol in between scans.
Measured: up to 2 hours
Right Ventricular Stroke Volume Pre and Post Metoprolol
Participants will receive intravenous metoprolol in between scans.
Measured: up to 2 hours
Right Ventricular Systolic Volume Pre and Post Metoprolol
Participants will receive intravenous metoprolol in between scans.
Measured: up to 2 hours
Right Ventricular Diastolic Volume Pre and Post Metoprolol
Participants will receive intravenous metoprolol in between scans.
Measured: up to 2 hours
Left Ventricular Ejection Fraction Pre and Post Metoprolol
Participants will receive intravenous metoprolol in between scans.
Measured: up to 2 hours
Left Ventricular Stroke Volume Pre and Post Metoprolol
Participants will receive intravenous metoprolol in between scans.
Measured: up to 2 hours
Left Ventricular Systolic Volume Pre and Post Metoprolol
Participants will receive intravenous metoprolol in between scans.
Measured: up to 2 hours
Left Ventricular Diastolic Volume Pre and Post Metoprolol
Participants will receive intravenous metoprolol in between scans.
Measured: up to 2 hours
Left Ventricular Energetic Efficiency Pre and Post Sildenafil
Kinetic energy (from 4D flow) normalized to ventricular volume (from MRI). Participants will be given sildenafil in between imaging scans.
Measured: up to 2 hours
Right Ventricular Ejection Fraction Pre and Post Sildenafil
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.
Measured: up to 2 hours
Right Ventricular Stroke Volume Pre and Post Sildenafil
Participants will be given sildenafil in between imaging scans.
Measured: up to 2 hours
Right Ventricular Systolic Volume Pre and Post Sildenafil
Participants will be given sildenafil in between imaging scans.
Measured: up to 2 hours
Right Ventricular Diastolic Volume Pre and Post Sildenafil
Participants will be given sildenafil in between imaging scans.
Measured: up to 2 hours
Left Ventricular Ejection Fraction Pre and Post Sildenafil
Participants will be given sildenafil in between imaging scans.
Measured: up to 2 hours
Left Ventricular Stroke Volume Pre and Post Sildenafil
Participants will be given sildenafil in between imaging scans.
Measured: up to 2 hours
Left Ventricular Systolic Volume Pre and Post Sildenafil
Participants will be given sildenafil in between imaging scans.
Measured: up to 2 hours
Left Ventricular Diastolic Volume Pre and Post Sildenafil
Participants will be given sildenafil in between imaging scans.
Measured: up to 2 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Oct 201824 Feb 2020

First posted5 Oct 2018
Study start30 Oct 2018
Primary completion24 Feb 2020
Study completion24 Feb 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Infant,PrematureStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Model description: 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.
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03696758
Sponsor's protocol ID: 2018-0796
Other IDs: 1UL1TR002373-01, A534285, SMPH/MEDICINE/PULMON MED, Protocol Version 8/30/2018
Status last verified: Feb 2021
First submitted: 3 Oct 2018
Last updated: 17 Mar 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Infant,Premature trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Improving Right Ventricular Function in Young Adults Born Preterm: A Pilot Study
ClinicalTrials.gov ID: NCT03696758
Acronym / sponsor ID: 2018-0796
Conditions: Infant,Premature
Keywords: premature adults, premature, premature cardiac function, MRI, sildenafil, metoprolol, CMR
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: University of Wisconsin, MadisonUniversity, hospital or other
Collaborators: National Center for Advancing Translational Sciences (NCATS)
Study start: 30 Oct 2018 (actual)
Primary completion: 24 Feb 2020 (actual)
Study completion: 24 Feb 2020 (actual)
First posted: 5 Oct 2018 (actual)
Results: Posted 25 Feb 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (outcomes assessor)
Number of arms: 2
Model description: 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.

Arm	Type	Receives
Sildenafil followed by Metoprolol	Experimental	Procedure: Pulmonary Function Testing, Procedure: Electrocardiogram, Procedure: Cardiac Magnetic Resonance Imaging, Drug: Metoprolol, Drug: SildenafilYoung 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	Experimental	Procedure: Pulmonary Function Testing, Procedure: Electrocardiogram, Procedure: Cardiac Magnetic Resonance Imaging, Drug: Metoprolol, Drug: SildenafilYoung 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.

Who may qualify

Ages: 18 to 35 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Provision of signed and dated informed consent form
Male or female aged 18-35
History of preterm birth (either a or b):

Key exclusion criteria (14 listed)

Pregnant or lactating
Use of prescribed medications that would interfere with study medications
Presence of known comorbidities for which these therapeutic interventions would be contraindicated:
Presence of any implanted device incompatible with CMR imaging
Known allergic or hypersensitivity reaction to components of the study medications

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Pulmonary Function TestingSubjects will undergo spirometry, Plethysmography, and diffusion capacity.	Procedure or surgery	Metoprolol followed by Sildenafil, Sildenafil followed by Metoprolol
ElectrocardiogramSubjects will undergo an electrocardiogram to ensure sinus rhythm	Procedure or surgery	Metoprolol followed by Sildenafil, Sildenafil followed by Metoprolol
Cardiac Magnetic Resonance ImagingSubjects will undergo positron magnetic resonance imaging to detect images of the heart	Procedure or surgery	Metoprolol followed by Sildenafil, Sildenafil followed by Metoprolol
MetoprololAlso: Lopressor, Metolar XRSubjects 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.	Drug	Metoprolol followed by Sildenafil, Sildenafil followed by Metoprolol
SildenafilAlso: RevatioSubjects will receive a 50 milligram tablet of sildenafil (to be taken orally)	Drug	Metoprolol followed by Sildenafil, Sildenafil followed by Metoprolol

Primary outcome

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.
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.

18 secondary outcomes

Left Ventricular Energetic Efficiency Pre and Post Metoprolol
Time frame: up to 2 hours
Right Ventricular Ejection Fraction Pre and Post Metoprolol
Time frame: up to 2 hours
Right Ventricular Stroke Volume Pre and Post Metoprolol
Time frame: up to 2 hours
Right Ventricular Systolic Volume Pre and Post Metoprolol
Time frame: up to 2 hours
Right Ventricular Diastolic Volume Pre and Post Metoprolol
Time frame: up to 2 hours
Left Ventricular Ejection Fraction Pre and Post Metoprolol
Time frame: up to 2 hours
Left Ventricular Stroke Volume Pre and Post Metoprolol
Time frame: up to 2 hours
Left Ventricular Systolic Volume Pre and Post Metoprolol
Time frame: up to 2 hours
Left Ventricular Diastolic Volume Pre and Post Metoprolol
Time frame: up to 2 hours
Left Ventricular Energetic Efficiency Pre and Post Sildenafil
Time frame: up to 2 hours
Right Ventricular Ejection Fraction Pre and Post Sildenafil
Time frame: up to 2 hours
Right Ventricular Stroke Volume Pre and Post Sildenafil
Time frame: up to 2 hours
Right Ventricular Systolic Volume Pre and Post Sildenafil
Time frame: up to 2 hours
Right Ventricular Diastolic Volume Pre and Post Sildenafil
Time frame: up to 2 hours
Left Ventricular Ejection Fraction Pre and Post Sildenafil
Time frame: up to 2 hours
Left Ventricular Stroke Volume Pre and Post Sildenafil
Time frame: up to 2 hours
Left Ventricular Systolic Volume Pre and Post Sildenafil
Time frame: up to 2 hours
Left Ventricular Diastolic Volume Pre and Post Sildenafil
Time frame: up to 2 hours

Results and safety

Results posted to the registry on 25 Feb 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sildenafil Followed by Metoprolol	3	3
Metoprolol Followed by Sildenafil	6	6

Primary outcome: Right Ventricular Energetic Efficiency Pre and Post Metoprolol

Time frame: up to 2 hours. Mean (Standard Deviation). Unit: µJ/ml

Measure	Young Adults Born Premature n = 9
Pre Metoprolol	15.5 (2.6)
Post Metoprolol	12.7 (2.5)

Young Adults Born Premature: p = 0.004, Wilcoxon Signed Rank Test

Primary outcome: Right Ventricular Energetic Efficiency Pre and Post Sildenafil

Time frame: up to 2 hours. Mean (Standard Deviation). Unit: µJ/ml

Measure	Young Adults Born Premature n = 9
Pre-Sildenafil	15.8 (3.7)
Post-Sildenafil	17.9 (6.2)

Young Adults Born Premature: p = 0.13, Wilcoxon Signed Rank Test

18 secondary outcomes are reported in the full results.

Adverse events

Time frame: 3 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sildenafil Followed by Metoprolol	0 of 3 (0%)	0 of 3 (0%)	0 of 3
Metoprolol Followed by Sildenafil	0 of 6 (0%)	0 of 6 (0%)	0 of 6

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kara N Goss, MD principal investigator

University of Wisconsin-Madison School of Medicine and Public Health

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Right Ventricular Energetic Efficiency Pre and Post Metoprolol (time frame: up to 2 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03696758.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2021.