NCT04707352

Impact on Atrial Remodeling of Dapaglifozin in Patients With Heart Failure .

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 162 (actual)
• Sponsor: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The reduction of death and HF related events observed with dapagliflozin make necessary to clarify the mechanisms underlying these clinical benefits. Currently, dapagliflozin is indicated in patients with diabetes irrespective of the presence of HF. The initiation in patients with HF represents an opportunity to elucidate the effect of dapagliflozin on cardiac remodeling in this population. Therefore, we propose a study that aims to assess the effects of dapagliflozin in echocardiographic parameters of cardiac remodeling, with special interest in LA geometry and function, as well as in biomarkers reflecting expanded pathophysiological pathways. LA volume has shown to identify the progression of HF irrespective of LVEF and, therefore, it represents a meaningful measure of the cardiac impact of dapagliflozin in the entire spectrum of chronic HF.

Conditions

• Heart Failure

Interventions

Type	Name	Description
DRUG	Dapagliflozin	All eligible subjects will receive Dapagliflozin 10 mg each day. The study treatment will be provided for the duration of the trial from baseline (Day 1) through last visit (Day 180).

Timeline

• Start date: 2021-02-08
• Primary completion: 2023-03-26
• Completion: 2023-03-26
• First posted: 2021-01-13
• Last updated: 2023-07-12

Locations

1 site across 1 country: Spain