Madison, Wisconsin 53792


Purpose:

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


Study summary:

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.


Criteria:

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.


Study is Available At:


Original ID:

2018-0796


NCT ID:

NCT03696758


Secondary ID:


Study Acronym:


Brief Title:

Improving Right Ventricular Function in Young Adults Born Preterm


Official Title:

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


Overall Status:

Recruiting


Study Phase:

Phase 2


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

35 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Wisconsin, Madison


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

10


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Kara N Goss, MD
Principal Investigator
University of Wisconsin-Madison School of Medicine and Public Health
Primary Contact:Tina M Palas, BS
608-265-4554
tmp@medicine.wisc.edu
Backup Contact:Mary Jo M Jackson, BSN
608-265-3556
mmj@medicine.wisc.edu

Study Dates

Start Date:October 30, 2018
Completion Date:September 2020
Completion Type:Anticipated
Primary Completion Date:September 2020
Primary Completion Type:Anticipated
Verification Date:December 2018
Last Changed Date:December 27, 2018
First Received Date:October 3, 2018

Study Outcomes

Outcome Type:Primary Outcome
Measure:Right ventricular energetic efficiency
Time Frame:Visits 2 and 3 (2 days)
Safety Issues:False
Description:mL/mJ
Outcome Type:Secondary Outcome
Measure:left ventricular energetic efficiency
Time Frame:Visits 2 and 3 (2 days)
Safety Issues:False
Description:mL/mJ

Study Interventions

Intervention Type:Procedure
Name:Pulmonary Function Testing
Description:Subjects will undergo spirometry, Plethsymography, and diffusion capacity.
Arm Name:Young adults born premature
Intervention Type:Procedure
Name:Electrocardiogram
Description:Subjects will undergo an electrocardiogram to ensure sinus rhythm
Arm Name:Young adults born premature
Intervention Type:Procedure
Name:Cardiac Magnetic Resonance Imaging
Description:Subjects will undergo positron magnetic resonance imaging to detect images of the heart
Arm Name:Young adults born premature
Intervention Type:Drug
Name:Metoprolol
Description:Subjects will receive intravenous metoprolol
Arm Name:Young adults born premature
Other Name:Lopressor
Intervention Type:Drug
Name:Sildenafil
Description:Subjects will receive a 50 milligram tablet of sildenafil (to be taken orally)
Arm Name:Young adults born premature
Other Name:Revatio

Study Arms

Study Arm Type:Experimental
Arm Name:Young adults born premature
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. Subjects will also undergo pulmonary function testing and elect

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Wisconsin, Madison

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

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