Impact on Atrial Remodeling of Dapaglifozin in Patients With Heart Failure .
Status:
Recruiting
Trial end date:
2022-05-30
Target enrollment:
Participant gender:
Summary
Dapagliflozin reduces the risk of de novo heart failure (HF) in diabetics and, recently, it
has shown to improve the prognosis of patients with HF and reduced left ventricular ejection
fraction (HFrEF), by preventing HF decompensations and cardiovascular death. The benefit
showed by dapagliflozin in HFrEF was irrespective of diabetes status and glycemic control,
which raises the question of which mechanisms are underlying apart from SGLT2 inhibition. In
addition, the impact of dapagliflozin on cardiac remodeling parameters, as assessed by
echocardiography and biomarkers, is not well established. In particular, left atrial (LA)
remodeling represents a relevant prognostic marker, which has received a greater attention in
the last years in the context of new imaging tools.
The purpose of this study is to assess the effect of dapagliflozin therapy over a period of 6
months in LA remodeling parameters, including geometry and function, as well as complementary
biomarkers in patients with chronic HF regardless left ventricular ejection fraction (LVEF).
This protocol will allow for evaluation of improved understanding of the interplay between
dapagliflozin and LA function , biomarkers, remodeling and outcomes, and will carefully
assess such relationships within important cohorts of subjects, such as those with reduced
and preserved LVEF.
This protocol will also generate a biorepository of well-handled and carefully considered
biomarkers, which will allow a better understanding of dapagliflozin mechanism of action.
Phase:
Phase 3
Details
Lead Sponsor:
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Collaborators:
Sociedad Española de Cardiologia SEC Spanish Society of Cardiology