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

NCT04707352 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 162

Last updated 2023-07-12

No results posted yet for this study

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.

Conditions

Interventions

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).

Sponsors & Collaborators

  • Spanish Society of Cardiology

    collaborator OTHER

  • Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

    lead OTHER

Principal Investigators

  • Domingo Pascual Figal · Hospital Universitario Virgen de la Arrixaca

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-08
Primary Completion
2023-03-26
Completion
2023-03-26

Countries

  • Spain

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04707352 on ClinicalTrials.gov