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Effects of empagliflozin on exercise capacity and LV diastolic function in HFpEF and type-2 diabetes mellitus: rationale and design of prospective intervention study

Session Poster Session 3

Speaker Anton Borisov

Event : Heart Failure 2019

  • Topic : heart failure
  • Sub-topic : Chronic Heart Failure: Pharmacotherapy
  • Session type : Poster Session

Authors : A Ovchinnikov (Moscow,RU), A Borisov (Moscow,RU), C Zherebchikova (Moscow,RU), O Ryabtseva (Moscow,RU), O Svirida (Moscow,RU), F Ageev (Moscow,RU)

Authors:
A Ovchinnikov1 , A Borisov1 , C Zherebchikova1 , O Ryabtseva1 , O Svirida1 , F Ageev1 , 1National Medical Research Center for Cardiology - Moscow - Russian Federation ,

Citation:

Background: To date, no specific treatment has been shown to improve outcomes in heart failure with preserved left ventricular ejection fraction (HFpEF). Type-2 diabetes mellitus (T2DM) has been identified as a major cause of HFpEF. EMPA-REG OUTCOME trial showed that empagliflozin is associated with reduction in heart failure death and hospitalization, making empagliflozin a new promising agent that could potentially improve outcomes in patients with HFpEF.

Purpose: to assess whether sodium glucose cotransporter 2 (SGLT2) inhibitor empagliflozin improves exercise capacity and left ventricular diastolic function in patients with HFpEF and T2DM.

Methods/Design: A total of 100 patients with stable HFpEF, NYHA functional class II-III and T2DM will be randomly allocated either to empagliflozin (10 mg o.d.; n=50) or control (n=50) group. In both groups patients will be receiving standard treatment for HF and T2DM. Echocardiography at rest and during exercise (diastolic stress-test, DST), 6-minute walk test (6MWT), Minnesota Living with Heart Failure Questionnaire (MLHFQ) score assessment, complete blood count, urinalysis, and biomarker blood tests (N-terminal pro b-type natriuretic peptide, endothelin 1, growth/differentiation factor 15, soluble ST2, galectin-3, interleukin-6, high-sensitivity C-reactive protein, carboxyterminal propeptide of type I collagen, pentraxin 3) will be performed at baseline and 24 weeks after randomization. DST will be performed as a supine bicycle test at 60 rpm starting at a 3-min period of low-level 25-W workload followed by 25-W increments every 3-min to maximum tolerated levels. During DST, mitral inflow velocities, mitral annulus tissue Doppler velocities, and peak tricuspid regurgitation velocity by continuous wave Doppler will be analyzed at baseline, during each stage including peak exercise and in recovery.

Outcome measures: Timeframe for all outcome measures is 24 weeks. The primary outcome measure is change from baseline in 6-minute walk distance (6MWD). Secondary outcome measures include change from baseline in DST exercise time, NYHA functional class, MLHFQ score, pulmonary capillary wedge pressure and pulmonary artery systolic pressure (assessed by echocardiography) both at rest and during DST, LV mass index, LA volume index, LA stiffness (assessed as a ratio of mitral E/e' ratio to LA strains), and biomarker blood levels.

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