Short-term effects of dapagliflozin on maximal functional capacity in heart failure with reduced ejection fraction (DAPA-VO(2) ): a randomized clinical trial.

Autores de INCLIVA

• Patricia Palau Sampio

  Autor

• Clara Sastre Arbona

  Autor

• Anna Mireia Mollar Fernandez

  Autor

• 

  Rafael De La Espriella Juan

  Autor

• Gema Miñana Escriva

  Autor

• Enrique Santas Olmeda

  Autor

• 

  Vicent Bodí Peris

  Autor

• 

  Juan Sanchis Fores

  Autor

• 

  Jose Luis Górriz Teruel

  Autor

• 

  Julio Nuñez Villota

  Autor

Participantes ajenos a INCLIVA

• Amiguet, M
• Dominguez, E
• Seller, J
• Pinilla, JMG
• Larumbe, A
• Valle, A
• Doblas, JJG
• Mezcua, AR
• Pascual-Figal, D
• Bayes-Genis, A
• DAPA-VO2 Investigators

Grupos y Plataformas de I+D+i

• Grupo de Enfermedad Renal

  

  Leading Researcher

  Jose Luis Górriz Teruel

• Grupo de investigación en Cardiología Clínica

  

  Leading Researcher

  Juan Sanchis Fores

• Grupo de Investigación en Insuficiencia Cardiaca

  

  Established Researcher

  Julio Nuñez Villota

• Grupo de Investigación Traslacional en Cardiopatía Isquémica

  

  Leading Researcher

  Vicent Bodí Peris

Abstract

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 (peakVO(2) ) 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 peakVO(2) , 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%). PeakVO(2) significantly increased in patients on treatment with dapagliflozin (1 month: + 1.09 ml/kg/min, 95% confidence interval [CI] 0.14-2.04; p = 0.021, and 3 months: + 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 peakVO(2) at 1 and 3 months. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04197635.

© 2022 European Society of Cardiology.

Keywords

• Dapagliflozin; Heart failure with reduced ejection fraction; Maximal functional capacity