Short-term diuretic withdrawal in stable outpatients with mild heart failure and no fluid retention receiving optimal therapy : a double-blind, multicentre, randomized trial
Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2019. For permissions, please email: journals.permissionsoup.com..
AIMS: Although loop diuretics are widely used to treat heart failure (HF), there is scarce contemporary data to guide diuretic adjustments in the outpatient setting.
METHODS AND RESULTS: In a prospective, randomized and double-blind protocol, we tested the safety and tolerability of withdrawing low-dose furosemide in stable HF outpatients at 11 HF clinics in Brazil. The trial had two blindly adjudicated co-primary outcomes: (i) symptoms assessment quantified as the area under the curve (AUC) of a dyspnoea score on a visual-analogue scale evaluated at 4 time-points (baseline, Day 15, Day 45, and Day 90) and (ii) the proportion of patients maintained without diuretic reuse during follow-up. We enrolled 188 patients (25% females; 59 ± 13 years old; left ventricular ejection fraction = 32 ± 8%) that were randomized to furosemide withdrawal (n = 95) or maintenance (n = 93). For the first co-primary endpoint, no significant difference in patients' assessment of dyspnoea was observed in the comparison of furosemide withdrawal with continuous administration [median AUC 1875 (interquartile range, IQR 383-3360) and 1541 (IQR 474-3124), respectively; P = 0.94]. For the second co-primary endpoint, 70 patients (75.3%) in the withdrawal group and 77 patients (83.7%) in the maintenance group were free of furosemide reuse during follow-up (odds ratio for additional furosemide use with withdrawal 1.69, 95% confidence interval 0.82-3.49; P = 0.16). Heart failure-related events (hospitalizations, emergency room visits, and deaths) were infrequent and similar between groups (P = 1.0).
CONCLUSIONS: Diuretic withdrawal did not result in neither increased self-perception of dyspnoea nor increased need of furosemide reuse. Diuretic discontinuation may deserve consideration in stable outpatients with no signs of fluid retention receiving optimal medical therapy.
CLINICALTRIALS.GOV IDENTIFIER: NCT02689180.
| Errataetall: |
CommentIn: Eur Heart J. 2019 Nov 21;40(44):3613-3615. - PMID 31562512 |
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| Medienart: |
E-Artikel |
| Erscheinungsjahr: |
2019 |
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| Erschienen: |
2019 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:40 |
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| Enthalten in: |
European heart journal - 40(2019), 44 vom: 21. Nov., Seite 3605-3612 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Rohde, Luis E [VerfasserIn] |
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| Links: |
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| Themen: |
7LXU5N7ZO5 |
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| Anmerkungen: |
Date Completed 27.10.2020 Date Revised 27.10.2020 published: Print ClinicalTrials.gov: NCT02689180 CommentIn: Eur Heart J. 2019 Nov 21;40(44):3613-3615. - PMID 31562512 Citation Status MEDLINE |
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| doi: |
10.1093/eurheartj/ehz554 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM300347200 |
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| 100 | 1 | |a Rohde, Luis E |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Short-term diuretic withdrawal in stable outpatients with mild heart failure and no fluid retention receiving optimal therapy |b a double-blind, multicentre, randomized trial |
| 264 | 1 | |c 2019 | |
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| 500 | |a Date Completed 27.10.2020 | ||
| 500 | |a Date Revised 27.10.2020 | ||
| 500 | |a published: Print | ||
| 500 | |a ClinicalTrials.gov: NCT02689180 | ||
| 500 | |a CommentIn: Eur Heart J. 2019 Nov 21;40(44):3613-3615. - PMID 31562512 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2019. For permissions, please email: journals.permissionsoup.com. | ||
| 520 | |a AIMS: Although loop diuretics are widely used to treat heart failure (HF), there is scarce contemporary data to guide diuretic adjustments in the outpatient setting | ||
| 520 | |a METHODS AND RESULTS: In a prospective, randomized and double-blind protocol, we tested the safety and tolerability of withdrawing low-dose furosemide in stable HF outpatients at 11 HF clinics in Brazil. The trial had two blindly adjudicated co-primary outcomes: (i) symptoms assessment quantified as the area under the curve (AUC) of a dyspnoea score on a visual-analogue scale evaluated at 4 time-points (baseline, Day 15, Day 45, and Day 90) and (ii) the proportion of patients maintained without diuretic reuse during follow-up. We enrolled 188 patients (25% females; 59 ± 13 years old; left ventricular ejection fraction = 32 ± 8%) that were randomized to furosemide withdrawal (n = 95) or maintenance (n = 93). For the first co-primary endpoint, no significant difference in patients' assessment of dyspnoea was observed in the comparison of furosemide withdrawal with continuous administration [median AUC 1875 (interquartile range, IQR 383-3360) and 1541 (IQR 474-3124), respectively; P = 0.94]. For the second co-primary endpoint, 70 patients (75.3%) in the withdrawal group and 77 patients (83.7%) in the maintenance group were free of furosemide reuse during follow-up (odds ratio for additional furosemide use with withdrawal 1.69, 95% confidence interval 0.82-3.49; P = 0.16). Heart failure-related events (hospitalizations, emergency room visits, and deaths) were infrequent and similar between groups (P = 1.0) | ||
| 520 | |a CONCLUSIONS: Diuretic withdrawal did not result in neither increased self-perception of dyspnoea nor increased need of furosemide reuse. Diuretic discontinuation may deserve consideration in stable outpatients with no signs of fluid retention receiving optimal medical therapy | ||
| 520 | |a CLINICALTRIALS.GOV IDENTIFIER: NCT02689180 | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Multicenter Study | |
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 4 | |a Dyspnoea | |
| 650 | 4 | |a Furosemide | |
| 650 | 4 | |a Heart failure | |
| 650 | 7 | |a Sodium Potassium Chloride Symporter Inhibitors |2 NLM | |
| 650 | 7 | |a Furosemide |2 NLM | |
| 650 | 7 | |a 7LXU5N7ZO5 |2 NLM | |
| 700 | 1 | |a Rover, Marciane M |e verfasserin |4 aut | |
| 700 | 1 | |a Figueiredo Neto, Jose A |e verfasserin |4 aut | |
| 700 | 1 | |a Danzmann, Luiz C |e verfasserin |4 aut | |
| 700 | 1 | |a Bertoldi, Eduardo G |e verfasserin |4 aut | |
| 700 | 1 | |a Simões, Marcus V |e verfasserin |4 aut | |
| 700 | 1 | |a Silvestre, Odilson M |e verfasserin |4 aut | |
| 700 | 1 | |a Ribeiro, Antonio L P |e verfasserin |4 aut | |
| 700 | 1 | |a Moura, Lidia Zytynski |e verfasserin |4 aut | |
| 700 | 1 | |a Beck-da-Silva, Luis |e verfasserin |4 aut | |
| 700 | 1 | |a Prado, Debora |e verfasserin |4 aut | |
| 700 | 1 | |a Sant'Anna, Roberto T |e verfasserin |4 aut | |
| 700 | 1 | |a Bridi, Leonardo H |e verfasserin |4 aut | |
| 700 | 1 | |a Zimerman, André |e verfasserin |4 aut | |
| 700 | 1 | |a Raupp da Rosa, Priscila |e verfasserin |4 aut | |
| 700 | 1 | |a Biolo, Andréia |e verfasserin |4 aut | |
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