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Sildenafil for Primary Prevention of Anthracycline-Induced Cardiac Toxicity: A Phase I/II Randomized Clinical Trial, SILDAT-TAHA6 Trial
BACKGROUND: Previous animal studies have shown a protective effect of 5-phosphodiesterase inhibitors on cancer therapeutics-related cardiac dysfunction (CTRCD) of anthracyclines. AIM: The aim of this study was to evaluate the clinical effect of sildenafil on the primary prevention of CTRCD in human....
Autores principales: | , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Hindawi
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8977337/ https://www.ncbi.nlm.nih.gov/pubmed/35387238 http://dx.doi.org/10.1155/2022/5681510 |
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author | Attar, Armin Heydari, Masoumeh Abtahi, Firoozeh Rezvani, Alireza Haghighat, Shirin Vojdani, Reza Ramzi, Mani Dehghani, Mehdi Karimi, Mojtaba Kasaei, Mohammad Khosropanah, Shahdad Tabandeh, Mahmood |
author_facet | Attar, Armin Heydari, Masoumeh Abtahi, Firoozeh Rezvani, Alireza Haghighat, Shirin Vojdani, Reza Ramzi, Mani Dehghani, Mehdi Karimi, Mojtaba Kasaei, Mohammad Khosropanah, Shahdad Tabandeh, Mahmood |
author_sort | Attar, Armin |
collection | PubMed |
description | BACKGROUND: Previous animal studies have shown a protective effect of 5-phosphodiesterase inhibitors on cancer therapeutics-related cardiac dysfunction (CTRCD) of anthracyclines. AIM: The aim of this study was to evaluate the clinical effect of sildenafil on the primary prevention of CTRCD in human. MATERIALS AND METHODS: In this randomized double-blind clinical trial, the primary end point was efficacy in preventing the reduction of left ventricular ejection fraction (LVEF). The intervention group patients received sildenafil at a dose of 25 milligrams twice a day before starting the chemotherapeutic regimen, and the control group received placebo. All the patients at baseline and after the 6-month follow-up underwent 4D and speckle-tracking echocardiography and cardiac MRI, accompanied by hs-troponin I and NT-Pro-BNP measurement. RESULTS: Sixty patients were enrolled in this study, and data from 52 patients (24 patients in the intervention group and 28 patients in the control group) were used in the final analysis. Our findings showed that in the intervention and control groups, LVEF was dropped from 61.28 ± 7.36 to 51.57 ± 7.67 (difference (D) = −9.71 ± 11.95, p=0.003) and from 57.9 ± 7.29 to 50.2 ± 7.02% (D = −7.7 ± 5.93; p=0.001), respectively (between-group difference = −2.01%, p=0.26). CTRCD was detected in 11 patients in the control group (42.8%) and 10 in the intervention group (41.6%, p=0.51). CONCLUSION: Consumption of sildenafil for primary prevention of anthracycline-induced cardiac toxicity seems to be unbeneficial. This trial is registered with IRCT20180506039554N1. |
format | Online Article Text |
id | pubmed-8977337 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | Hindawi |
record_format | MEDLINE/PubMed |
spelling | pubmed-89773372022-04-05 Sildenafil for Primary Prevention of Anthracycline-Induced Cardiac Toxicity: A Phase I/II Randomized Clinical Trial, SILDAT-TAHA6 Trial Attar, Armin Heydari, Masoumeh Abtahi, Firoozeh Rezvani, Alireza Haghighat, Shirin Vojdani, Reza Ramzi, Mani Dehghani, Mehdi Karimi, Mojtaba Kasaei, Mohammad Khosropanah, Shahdad Tabandeh, Mahmood Cardiol Res Pract Research Article BACKGROUND: Previous animal studies have shown a protective effect of 5-phosphodiesterase inhibitors on cancer therapeutics-related cardiac dysfunction (CTRCD) of anthracyclines. AIM: The aim of this study was to evaluate the clinical effect of sildenafil on the primary prevention of CTRCD in human. MATERIALS AND METHODS: In this randomized double-blind clinical trial, the primary end point was efficacy in preventing the reduction of left ventricular ejection fraction (LVEF). The intervention group patients received sildenafil at a dose of 25 milligrams twice a day before starting the chemotherapeutic regimen, and the control group received placebo. All the patients at baseline and after the 6-month follow-up underwent 4D and speckle-tracking echocardiography and cardiac MRI, accompanied by hs-troponin I and NT-Pro-BNP measurement. RESULTS: Sixty patients were enrolled in this study, and data from 52 patients (24 patients in the intervention group and 28 patients in the control group) were used in the final analysis. Our findings showed that in the intervention and control groups, LVEF was dropped from 61.28 ± 7.36 to 51.57 ± 7.67 (difference (D) = −9.71 ± 11.95, p=0.003) and from 57.9 ± 7.29 to 50.2 ± 7.02% (D = −7.7 ± 5.93; p=0.001), respectively (between-group difference = −2.01%, p=0.26). CTRCD was detected in 11 patients in the control group (42.8%) and 10 in the intervention group (41.6%, p=0.51). CONCLUSION: Consumption of sildenafil for primary prevention of anthracycline-induced cardiac toxicity seems to be unbeneficial. This trial is registered with IRCT20180506039554N1. Hindawi 2022-03-27 /pmc/articles/PMC8977337/ /pubmed/35387238 http://dx.doi.org/10.1155/2022/5681510 Text en Copyright © 2022 Armin Attar et al. https://creativecommons.org/licenses/by/4.0/This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Research Article Attar, Armin Heydari, Masoumeh Abtahi, Firoozeh Rezvani, Alireza Haghighat, Shirin Vojdani, Reza Ramzi, Mani Dehghani, Mehdi Karimi, Mojtaba Kasaei, Mohammad Khosropanah, Shahdad Tabandeh, Mahmood Sildenafil for Primary Prevention of Anthracycline-Induced Cardiac Toxicity: A Phase I/II Randomized Clinical Trial, SILDAT-TAHA6 Trial |
title | Sildenafil for Primary Prevention of Anthracycline-Induced Cardiac Toxicity: A Phase I/II Randomized Clinical Trial, SILDAT-TAHA6 Trial |
title_full | Sildenafil for Primary Prevention of Anthracycline-Induced Cardiac Toxicity: A Phase I/II Randomized Clinical Trial, SILDAT-TAHA6 Trial |
title_fullStr | Sildenafil for Primary Prevention of Anthracycline-Induced Cardiac Toxicity: A Phase I/II Randomized Clinical Trial, SILDAT-TAHA6 Trial |
title_full_unstemmed | Sildenafil for Primary Prevention of Anthracycline-Induced Cardiac Toxicity: A Phase I/II Randomized Clinical Trial, SILDAT-TAHA6 Trial |
title_short | Sildenafil for Primary Prevention of Anthracycline-Induced Cardiac Toxicity: A Phase I/II Randomized Clinical Trial, SILDAT-TAHA6 Trial |
title_sort | sildenafil for primary prevention of anthracycline-induced cardiac toxicity: a phase i/ii randomized clinical trial, sildat-taha6 trial |
topic | Research Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8977337/ https://www.ncbi.nlm.nih.gov/pubmed/35387238 http://dx.doi.org/10.1155/2022/5681510 |
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