The Effect of Udenafil on Heart Rate and Blood Pressure in Adolescents With the Fontan Circulation

dc.contributor.authorEdelson, Jonathan B.
dc.contributor.authorZak, Victor
dc.contributor.authorGoldberg, David
dc.contributor.authorFleming, Greg
dc.contributor.authorMackie, Andrew S.
dc.contributor.authorPatel, Jyoti K.
dc.contributor.authorFiles, Matthew
dc.contributor.authorDowning, Tacy
dc.contributor.authorRichmond, Marc
dc.contributor.authorAcheampong, Ben
dc.contributor.authorCartoski, Mark
dc.contributor.authorDetterich, Jon
dc.contributor.authorMcCrindle, Brian
dc.contributor.authorMcHugh, Kimberly
dc.contributor.authorHansen, Jesse E.
dc.contributor.authorWagner, Jonathan
dc.contributor.authorDi Maria, Michael
dc.contributor.authorWeingarten, Angela
dc.contributor.authorNowlen, Todd
dc.contributor.authorYoon, Ja Kyoung
dc.contributor.authorKim, Gi Beom
dc.contributor.authorWilliams, Richard
dc.contributor.authorWhitehill, Robert
dc.contributor.authorKirkpatrick, Edward
dc.contributor.authorYin, Suellen
dc.contributor.authorErmis, Peter
dc.contributor.authorLubert, Adam M.
dc.contributor.authorStylianou, Mario
dc.contributor.authorFreemon, D'Andrea
dc.contributor.authorHu, Chenwei
dc.contributor.authorGaruba, Olukayode D.
dc.contributor.authorFrommelt, Peter
dc.contributor.authorGoldstein, Bryan H.
dc.contributor.authorParidon, Stephen
dc.contributor.authorGarg, Ruchira
dc.contributor.authorPediatric Heart Network Investigators
dc.contributor.departmentPediatrics, School of Medicine
dc.date.accessioned2025-02-18T14:38:52Z
dc.date.available2025-02-18T14:38:52Z
dc.date.issued2024
dc.description.abstractThe Fontan Udenafil Exercise Longitudinal (FUEL) trial showed that treatment with udenafil was associated with improved exercise performance at the ventilatory anaerobic threshold in children with Fontan physiology. However, it is not known how the initiation of phosphodiesterase 5 inhibitor therapy affects heart rate and blood pressure in this population. These data may help inform patient selection and monitoring after the initiation of udenafil therapy. The purpose of this study is to evaluate the effects of udenafil on vital signs in the cohort of patients enrolled in the FUEL trial. This international, multicenter, randomized, double-blind, placebo-controlled trial of udenafil included adolescents with single ventricle congenital heart disease who had undergone Fontan palliation. Changes in vital signs (heart rate [HR], systolic [SBP] and diastolic blood pressure [DBP]) were compared both to subject baseline and between the treatment and the placebo groups. Additional exploratory analyses were performed to evaluate changes in vital signs for prespecified subpopulations believed to be most sensitive to udenafil initiation. Baseline characteristics were similar between the treatment and placebo cohorts (n = 200 for each). The groups demonstrated a decrease in HR, SBP, and DBP 2 hours after drug/placebo administration, except SBP in the placebo group. There was an increase in SBP from baseline to after 6-min walk test in the treatment and placebo groups, and the treatment group showed an increase in HR (87.4 ± 15.0 to 93.1 ± 19.4 beats/min, p <0.01) after exercise. When comparing changes from baseline to the 26-week study visit, small decreases in both SBP (-1.9 ± 12.3 mm Hg, p = 0.03) and DBP (-3.0 ± 9.6 mm Hg, p <0.01) were seen in the treatment group. There were no clinically significant differences between treatment and placebo group in change in HR or blood pressure in the youngest age quartile, lightest weight quartile, or those on afterload-reducing agents. In conclusion, initiation of treatment with udenafil in patients with Fontan circulation was not associated with clinically significant changes in vital signs, implying that for patients similar to those enrolled in the FUEL trial, udenafil can be started without the requirement for additional monitoring after initial administration.
dc.eprint.versionAuthor's manuscript
dc.identifier.citationEdelson JB, Zak V, Goldberg D, et al. The Effect of Udenafil on Heart Rate and Blood Pressure in Adolescents With the Fontan Circulation. Am J Cardiol. 2024;210:183-187. doi:10.1016/j.amjcard.2023.09.115
dc.identifier.urihttps://hdl.handle.net/1805/45792
dc.language.isoen_US
dc.publisherElsevier
dc.relation.isversionof10.1016/j.amjcard.2023.09.115
dc.relation.journalThe American Journal of Cardiology
dc.rightsPublisher Policy
dc.sourcePMC
dc.subjectFontan procedure
dc.subjectPhosphodiesterase 5 inhibitor
dc.subjectSingle ventricle
dc.titleThe Effect of Udenafil on Heart Rate and Blood Pressure in Adolescents With the Fontan Circulation
dc.typeArticle
Files
Original bundle
Now showing 1 - 1 of 1
Loading...
Thumbnail Image
Name:
Edelson2024Effect-AAM.pdf
Size:
90.2 KB
Format:
Adobe Portable Document Format
License bundle
Now showing 1 - 1 of 1
No Thumbnail Available
Name:
license.txt
Size:
2.04 KB
Format:
Item-specific license agreed upon to submission
Description: