The GUIDE-HF trial of pulmonary artery pressure monitoring in heart failure : impact of the COVID-19 pandemic
© The Author(s) 2022. Published by Oxford University Press on behalf of European Society of Cardiology. All rights reserved. For permissions, please e-mail: journals.permissionsoup.com..
AIMS: During the coronavirus disease 2019 (COVID-19) pandemic, important changes in heart failure (HF) event rates have been widely reported, but few data address potential causes for these changes; several possibilities were examined in the GUIDE-HF study.
METHODS AND RESULTS: From 15 March 2018 to 20 December 2019, patients were randomized to haemodynamic-guided management (treatment) vs. control for 12 months, with a primary endpoint of all-cause mortality plus HF events. Pre-COVID-19, the primary endpoint rate was 0.553 vs. 0.682 events/patient-year in the treatment vs. control group [hazard ratio (HR) 0.81, P = 0.049]. Treatment difference was no longer evident during COVID-19 (HR 1.11, P = 0.526), with a 21% decrease in the control group (0.536 events/patient-year) and no change in the treatment group (0.597 events/patient-year). Data reflecting provider-, disease-, and patient-dependent factors that might change the primary endpoint rate during COVID-19 were examined. Subject contact frequency was similar in the treatment vs. control group before and during COVID-19. During COVID-19, the monthly rate of medication changes fell 19.2% in the treatment vs. 10.7% in the control group to levels not different between groups (P = 0.362). COVID-19 was infrequent and not different between groups. Pulmonary artery pressure area under the curve decreased -98 mmHg-days in the treatment group vs. -100 mmHg-days in the controls (P = 0.867). Patient compliance with the study protocol was maintained during COVID-19 in both groups.
CONCLUSION: During COVID-19, the primary event rate decreased in the controls and remained low in the treatment group, resulting in an effacement of group differences that were present pre-COVID-19. These outcomes did not result from changes in provider- or disease-dependent factors; pulmonary artery pressure decreased despite fewer medication changes, suggesting that patient-dependent factors played an important role in these outcomes. Clinical Trials.gov: NCT03387813.
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| Medienart: |
E-Artikel |
| Erscheinungsjahr: |
2022 |
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| Erschienen: |
2022 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:43 |
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| Enthalten in: |
European heart journal - 43(2022), 27 vom: 14. Juli, Seite 2603-2618 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Zile, Michael R [VerfasserIn] |
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| Links: |
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| Themen: |
COVID-19 |
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| Anmerkungen: |
Date Completed 15.07.2022 Date Revised 16.08.2022 published: Print ClinicalTrials.gov: NCT03387813 CommentIn: Eur Heart J. 2022 May 02;:. - PMID 35511076 Citation Status MEDLINE |
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| doi: |
10.1093/eurheartj/ehac114 |
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| PPN (Katalog-ID): |
NLM337968756 |
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| 100 | 1 | |a Zile, Michael R |e verfasserin |4 aut | |
| 245 | 1 | 4 | |a The GUIDE-HF trial of pulmonary artery pressure monitoring in heart failure |b impact of the COVID-19 pandemic |
| 264 | 1 | |c 2022 | |
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| 500 | |a Date Completed 15.07.2022 | ||
| 500 | |a Date Revised 16.08.2022 | ||
| 500 | |a published: Print | ||
| 500 | |a ClinicalTrials.gov: NCT03387813 | ||
| 500 | |a CommentIn: Eur Heart J. 2022 May 02;:. - PMID 35511076 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © The Author(s) 2022. Published by Oxford University Press on behalf of European Society of Cardiology. All rights reserved. For permissions, please e-mail: journals.permissionsoup.com. | ||
| 520 | |a AIMS: During the coronavirus disease 2019 (COVID-19) pandemic, important changes in heart failure (HF) event rates have been widely reported, but few data address potential causes for these changes; several possibilities were examined in the GUIDE-HF study | ||
| 520 | |a METHODS AND RESULTS: From 15 March 2018 to 20 December 2019, patients were randomized to haemodynamic-guided management (treatment) vs. control for 12 months, with a primary endpoint of all-cause mortality plus HF events. Pre-COVID-19, the primary endpoint rate was 0.553 vs. 0.682 events/patient-year in the treatment vs. control group [hazard ratio (HR) 0.81, P = 0.049]. Treatment difference was no longer evident during COVID-19 (HR 1.11, P = 0.526), with a 21% decrease in the control group (0.536 events/patient-year) and no change in the treatment group (0.597 events/patient-year). Data reflecting provider-, disease-, and patient-dependent factors that might change the primary endpoint rate during COVID-19 were examined. Subject contact frequency was similar in the treatment vs. control group before and during COVID-19. During COVID-19, the monthly rate of medication changes fell 19.2% in the treatment vs. 10.7% in the control group to levels not different between groups (P = 0.362). COVID-19 was infrequent and not different between groups. Pulmonary artery pressure area under the curve decreased -98 mmHg-days in the treatment group vs. -100 mmHg-days in the controls (P = 0.867). Patient compliance with the study protocol was maintained during COVID-19 in both groups | ||
| 520 | |a CONCLUSION: During COVID-19, the primary event rate decreased in the controls and remained low in the treatment group, resulting in an effacement of group differences that were present pre-COVID-19. These outcomes did not result from changes in provider- or disease-dependent factors; pulmonary artery pressure decreased despite fewer medication changes, suggesting that patient-dependent factors played an important role in these outcomes. Clinical Trials.gov: NCT03387813 | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 4 | |a COVID-19 | |
| 650 | 4 | |a Haemodynamics | |
| 650 | 4 | |a Heart failure | |
| 650 | 4 | |a Pulmonary artery pressure | |
| 700 | 1 | |a Desai, Akshay S |e verfasserin |4 aut | |
| 700 | 1 | |a Costanzo, Maria Rosa |e verfasserin |4 aut | |
| 700 | 1 | |a Ducharme, Anique |e verfasserin |4 aut | |
| 700 | 1 | |a Maisel, Alan |e verfasserin |4 aut | |
| 700 | 1 | |a Mehra, Mandeep R |e verfasserin |4 aut | |
| 700 | 1 | |a Paul, Sara |e verfasserin |4 aut | |
| 700 | 1 | |a Sears, Samuel F |e verfasserin |4 aut | |
| 700 | 1 | |a Smart, Frank |e verfasserin |4 aut | |
| 700 | 1 | |a Chien, Christopher |e verfasserin |4 aut | |
| 700 | 1 | |a Guha, Ashrith |e verfasserin |4 aut | |
| 700 | 1 | |a Guichard, Jason L |e verfasserin |4 aut | |
| 700 | 1 | |a Hall, Shelley |e verfasserin |4 aut | |
| 700 | 1 | |a Jonsson, Orvar |e verfasserin |4 aut | |
| 700 | 1 | |a Johnson, Nessa |e verfasserin |4 aut | |
| 700 | 1 | |a Sood, Poornima |e verfasserin |4 aut | |
| 700 | 1 | |a Henderson, John |e verfasserin |4 aut | |
| 700 | 1 | |a Adamson, Philip B |e verfasserin |4 aut | |
| 700 | 1 | |a Lindenfeld, JoAnn |e verfasserin |4 aut | |
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