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

Sponsor:

Collaborators:

Information provided by (Responsible Party):

，

Tracking Information

First Submitted Date ^ICMJE

October 3, 2018

First Posted Date ^ICMJE

October 5, 2018

Last Update Posted Date

October 5, 2018

Actual Study Start Date ^ICMJE

November 2018

Estimated Primary Completion Date

September 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Right ventricular energetic efficiency[ Time Frame: Visits 2 and 3 (2 days) ]

mL/mJ

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

left ventricular energetic efficiency[ Time Frame: Visits 2 and 3 (2 days) ]
mL/mJ

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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.

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation:
Intervention Model: Single Group Assignment
Intervention 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.
Masking: Interventional
Masking Description:
Primary Purpose: Treatment

Condition ^ICMJE

Intervention ^ICMJE

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

Study Arms

Experimental: Young adults born premature
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 electrocardiogram.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

September 2020

Estimated Primary Completion Date

September 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

，

Study Sponsor ^ICMJE

University of Wisconsin, Madison

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator: Kara N Goss, MD University of Wisconsin-Madison School of Medicine and Public Health

PRS Account

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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