Short-term effects of dapagliflozin on maximal functional capacity in heart failure with reduced ejection fraction (DAPA-VO2): a randomized clinical trial
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Other documents of the author: Palau, Patricia; Amiguet Comins, Martina; Domínguez Mafé, Eloy; Sastre, Clara; Mollar, Anna; Seller, Julia; GARCIA-PINILLA, JOSE MANUEL; Larumbe, Ainoha; Valle, Alfonso; Gómez Doblas, Juan José; De la Espriella, Rafael; Miñana, Gema; Robles Mezcua, Ainhoa; Santas, Enrique; Bodí, Vicent; Sanchis, Juan; Pascual-Figal, Domingo A.; Gorriz, Jose Luis; Bayes-Genis, Antoni; Núñez, Julio
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https://doi.org/10.1002/ejhf.2560 |
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Title
Short-term effects of dapagliflozin on maximal functional capacity in heart failure with reduced ejection fraction (DAPA-VO2): a randomized clinical trialAuthor (s)
Date
2022-05-23Publisher
WileyBibliographic citation
PALAU, Patricia, et al. Short‐term effects of dapagliflozin on maximal functional capacity in heart failure with reduced ejection fraction (DAPA‐VO2): a randomized clinical trial. European Journal of Heart Failure, 2022, vol. 24, no 10, p. 1816-1826.Type
info:eu-repo/semantics/articleVersion
info:eu-repo/semantics/publishedVersionAbstract
Aims
This study aimed to evaluate the effect of dapagliflozin on 1 and 3-month maximal functional capacity in patients with stable heart failure with reduced ejection fraction (HFrEF).
Methods and results
In this ... [+]
Aims
This study aimed to evaluate the effect of dapagliflozin on 1 and 3-month maximal functional capacity in patients with stable heart failure with reduced ejection fraction (HFrEF).
Methods and results
In this multicentre, randomized, double-blind clinical trial, 90 stable patients with HFrEF were randomly assigned to receive either dapagliflozin (n = 45) or placebo (n = 45). The primary outcome was a change in peak oxygen consumption (peakVO2) at 1 and 3 months. Secondary endpoints were changes at 1 and 3 months in 6-min walk test (6MWT) distance, quality of life (Minnesota Living with Heart Failure Questionnaire [MLHFQ]), and echocardiographic parameters (diastolic function, left chamber volumes, and left ventricular ejection fraction). We used linear mixed regression analysis to compare endpoint changes. Estimates were adjusted for multiple comparisons. The mean age was 67.1 ± 10.7 years, 69 (76.7%) were men, 29 (32.2%) had type 2 diabetes, and 80 (88.9%) were in New York Heart Association class II. Baseline means of peakVO2, 6MWT and MLHFQ were 13.2 ± 3.5 ml/kg/min, 363 ± 110 m, and 23.1 ± 16.2, respectively. The median (25th–75th percentile) of N-terminal pro-brain natriuretic peptide was 1221 pg/ml (889–2100). Most patients were on treatment with sacubitril/valsartan (88.9%), beta-blockers (91.1%), and mineralocorticoid receptor antagonists (74.4%). PeakVO2 significantly increased in patients on treatment with dapagliflozin (1 month: +Δ 1.09 ml/kg/min, 95% confidence interval [CI] 0.14–2.04; p = 0.021, and 3 months: +Δ 1.06 ml/kg/min, 95% CI 0.07–2.04; p = 0.032). Similar positive findings were found when evaluating changes from baseline. No significant differences were observed in secondary endpoints.
Conclusions
Among patients with stable HFrEF, dapagliflozin resulted in a significant improvement in peakVO2 at 1 and 3 months. [-]
Funder Name
AstraZeneca | Unidad de Investigación Clínica y Ensayos Clínicos INCLIVA Health Research Institute | Spanish Clinical Research Network | CIBER Cardiovascular
Project code
PT17/0017/0003 | PT20/00100 | 16/11/00420 | 16/11/00403
Rights
Maximal functional capacity
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http://rightsstatements.org/vocab/InC/1.0/
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