Protocol of BEYOND trial: Clinical BEnefit of sodium-glucose cotransporter-2 (SGLT-2) inhibitors in rhYthm cONtrol of atrial fibrillation in patients with diabetes mellitus
SGLT-2 inhibitor, traditionally used for glycemic control, has several beneficial effects that can help manage heart failure (HF). SGLT-2 inhibitors reduce the risk of cardiovascular mortality in patients with HF. As atrial fibrillation (AF) is closely associated with HF and diabetes mellitus (DM) i...
| Main Authors: | , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Public Library of Science (PLoS)
2023-01-01
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| Series: | PLoS ONE |
| Online Access: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9847966/?tool=EBI |
| _version_ | 1797943957944008704 |
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| author | Kyuhyun Lee Soo Kyoung Lee Juyeon Lee Bo Kyung Jeon Tae-Hoon Kim Hee Tae Yu Jung Myung Lee Jin-Kyu Park Yong-Soo Baek Dong Hyeok Kim Jaemin Shim Boyoung Joung Moon-Hyoung Lee Hui-Nam Pak Junbeom Park |
| author_facet | Kyuhyun Lee Soo Kyoung Lee Juyeon Lee Bo Kyung Jeon Tae-Hoon Kim Hee Tae Yu Jung Myung Lee Jin-Kyu Park Yong-Soo Baek Dong Hyeok Kim Jaemin Shim Boyoung Joung Moon-Hyoung Lee Hui-Nam Pak Junbeom Park |
| author_sort | Kyuhyun Lee |
| collection | DOAJ |
| description | SGLT-2 inhibitor, traditionally used for glycemic control, has several beneficial effects that can help manage heart failure (HF). SGLT-2 inhibitors reduce the risk of cardiovascular mortality in patients with HF. As atrial fibrillation (AF) is closely associated with HF and diabetes mellitus (DM) is a risk factor for AF, we assume that SGLT-2 inhibitors will also show therapeutic benefits regarding AF, especially for rhythm control. This trial has a multicenter, prospective, open, blinded endpoint design. It is a 1:1 randomized and controlled study. A total of 716 patients who are newly diagnosed of AF and DM within 1 year will be enrolled from 7 tertiary medical centers. The trial is designed to compare the effects of SGLT-2 inhibitors and other oral hypoglycemic agents on atrial rhythm control in patients with AF and DM. The primary outcome is the recurrence of AF within a year (including post-antiarrhythmic drugs (AAD) or ablation). The secondary outcomes are the ablation rate within a year, change in AF burden, size of the left atrium, NT-proBNP, the AF symptom score, and the quality of life. This trial will prospectively evaluate the effect and safety of SGLT-2 inhibitors on AF rhythm control in patients with DM. It will provide an invaluable dataset on rhythm control in AF with DM for future studies and offer novel information to assist in clinical decisions. (BEYOND trial, ClinicalTrials.gov number: NCT05029115. https://clinicaltrials.gov/ct2/show/NCT05029115). |
| first_indexed | 2024-04-10T20:32:15Z |
| format | Article |
| id | doaj.art-d9cee7e66b1d43a1b4360491ce5a1f0c |
| institution | Directory Open Access Journal |
| issn | 1932-6203 |
| language | English |
| last_indexed | 2024-04-10T20:32:15Z |
| publishDate | 2023-01-01 |
| publisher | Public Library of Science (PLoS) |
| record_format | Article |
| series | PLoS ONE |
| spelling | doaj.art-d9cee7e66b1d43a1b4360491ce5a1f0c2023-01-25T05:34:00ZengPublic Library of Science (PLoS)PLoS ONE1932-62032023-01-01181Protocol of BEYOND trial: Clinical BEnefit of sodium-glucose cotransporter-2 (SGLT-2) inhibitors in rhYthm cONtrol of atrial fibrillation in patients with diabetes mellitusKyuhyun LeeSoo Kyoung LeeJuyeon LeeBo Kyung JeonTae-Hoon KimHee Tae YuJung Myung LeeJin-Kyu ParkYong-Soo BaekDong Hyeok KimJaemin ShimBoyoung JoungMoon-Hyoung LeeHui-Nam PakJunbeom ParkSGLT-2 inhibitor, traditionally used for glycemic control, has several beneficial effects that can help manage heart failure (HF). SGLT-2 inhibitors reduce the risk of cardiovascular mortality in patients with HF. As atrial fibrillation (AF) is closely associated with HF and diabetes mellitus (DM) is a risk factor for AF, we assume that SGLT-2 inhibitors will also show therapeutic benefits regarding AF, especially for rhythm control. This trial has a multicenter, prospective, open, blinded endpoint design. It is a 1:1 randomized and controlled study. A total of 716 patients who are newly diagnosed of AF and DM within 1 year will be enrolled from 7 tertiary medical centers. The trial is designed to compare the effects of SGLT-2 inhibitors and other oral hypoglycemic agents on atrial rhythm control in patients with AF and DM. The primary outcome is the recurrence of AF within a year (including post-antiarrhythmic drugs (AAD) or ablation). The secondary outcomes are the ablation rate within a year, change in AF burden, size of the left atrium, NT-proBNP, the AF symptom score, and the quality of life. This trial will prospectively evaluate the effect and safety of SGLT-2 inhibitors on AF rhythm control in patients with DM. It will provide an invaluable dataset on rhythm control in AF with DM for future studies and offer novel information to assist in clinical decisions. (BEYOND trial, ClinicalTrials.gov number: NCT05029115. https://clinicaltrials.gov/ct2/show/NCT05029115).https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9847966/?tool=EBI |
| spellingShingle | Kyuhyun Lee Soo Kyoung Lee Juyeon Lee Bo Kyung Jeon Tae-Hoon Kim Hee Tae Yu Jung Myung Lee Jin-Kyu Park Yong-Soo Baek Dong Hyeok Kim Jaemin Shim Boyoung Joung Moon-Hyoung Lee Hui-Nam Pak Junbeom Park Protocol of BEYOND trial: Clinical BEnefit of sodium-glucose cotransporter-2 (SGLT-2) inhibitors in rhYthm cONtrol of atrial fibrillation in patients with diabetes mellitus PLoS ONE |
| title | Protocol of BEYOND trial: Clinical BEnefit of sodium-glucose cotransporter-2 (SGLT-2) inhibitors in rhYthm cONtrol of atrial fibrillation in patients with diabetes mellitus |
| title_full | Protocol of BEYOND trial: Clinical BEnefit of sodium-glucose cotransporter-2 (SGLT-2) inhibitors in rhYthm cONtrol of atrial fibrillation in patients with diabetes mellitus |
| title_fullStr | Protocol of BEYOND trial: Clinical BEnefit of sodium-glucose cotransporter-2 (SGLT-2) inhibitors in rhYthm cONtrol of atrial fibrillation in patients with diabetes mellitus |
| title_full_unstemmed | Protocol of BEYOND trial: Clinical BEnefit of sodium-glucose cotransporter-2 (SGLT-2) inhibitors in rhYthm cONtrol of atrial fibrillation in patients with diabetes mellitus |
| title_short | Protocol of BEYOND trial: Clinical BEnefit of sodium-glucose cotransporter-2 (SGLT-2) inhibitors in rhYthm cONtrol of atrial fibrillation in patients with diabetes mellitus |
| title_sort | protocol of beyond trial clinical benefit of sodium glucose cotransporter 2 sglt 2 inhibitors in rhythm control of atrial fibrillation in patients with diabetes mellitus |
| url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9847966/?tool=EBI |
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