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.


NCT ID:

NCT03696758


Primary Contact:

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

Tina M Palas, BS
Phone: 608-265-4554
Email: tmp@medicine.wisc.edu


Backup Contact:

Email: mmj@medicine.wisc.edu
Mary Jo M Jackson, BSN
Phone: 608-265-3556


Location Contact:

Madison, Wisconsin 53792
United States

Tina M Palas, BS
Phone: 608-265-4554
Email: tmp@medicine.wisc.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: February 04, 2019

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