Short‐term effects of dapagliflozin on maximal functional capacity in heart failure with reduced ejection fraction (DAPA‐VO2): a randomized clinical trial. (6th June 2022)

• Record Type: Journal Article
• Authors: Palau, Patricia; Amiguet, Martina; Domínguez, Eloy; Sastre, Clara; Mollar, Anna; Seller, Julia; Garcia Pinilla, Jose Manuel; Larumbe, Ainoha; Valle, Alfonso; Gómez Doblas, Juan Jose; de la Espriella, Rafael; Miñana, Gema; Mezcua, Ainhoa Robles; Santas, Enrique; Bodí, Vicent; Sanchis, Juan; Pascual‐Figal, Domingo; Górriz, Jose Luis; Baýes‐Genís, Antonio; Núñez, Julio
• Other Names: Palau Patricia investigator.; Amiguet Martina investigator.; Domínguez Eloy investigator.; Sastre Clara investigator.; Mollar Anna investigator.; Seller Julia investigator.; Pinilla Jose Manuel Garcia investigator.; Larumbe Ainoha investigator.; Valle Alfonso investigator.; Doblas Juan Jose Gómez investigator.; de la Espriella Rafael investigator.; Miñana Gema investigator.; Mezcua Ainhoa Robles investigator.; Santas Enrique investigator.; Bodí Vicent investigator.; Sanchis Juan investigator.; Pascual‐Figal Domingo investigator.; Górriz Jose Luis investigator.; Baýes‐Genís Antonio investigator.; Civera Jose investigator.; Conesa Adriana investigator.; Zakarne Rim investigator.; Rubio Clara Jiménez investigator.; Pérez Cabeza Alejandro I. investigator.; Expósito Arancha Díaz investigator.; Carmona José David Martínez investigator.; Morales Manuel Luna investigator.; Zafra Sánchez Francisco J. investigator.; Trujillo Ángel Montiel investigator.; Climent Herminio Morillas investigator.; Núñez Julio investigator.;
• Is Part Of: European journal of heart failure. Volume 24:Number 10(2022)
• Page Start: 1816
• Page End: 1826
• Publication Date: 2022-06-06
• Subjects: Dapagliflozin -- Heart failure with reduced ejection fraction -- Maximal functional capacity; Heart failure -- Periodicals; Heart Failure -- Periodicals; Insuffisance cardiaque -- Périodiques; Heart failure; Periodicals; 616.129005
• DOI: 10.1002/ejhf.2560
• Languages: English
• ISSNs: 1388-9842

Abstract

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 (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. Clinical Trial Registration: ClinicalTrials.gov Identifier: NCT04197635. Abstract : Patients with clinically stable heart failure with reduced ejection fraction (HFrEF) were randomized to receive dapagliflozin or placebo (1:1). The primary endpoint was a change in maximal functional capacity assessed by peak oxygen consumption (peakVO2 ) at 1 and 3 months. Patients on dapagliflozin showed higher peakVO2 at 1 and 3 months. Δ‐peakVO2, changes from baseline in peak oxygen consumption; NYHA, New York Heart Association.