CompletedPhase 3

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

Spain162 participantsStarted 2021-02-08

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age \> 18 years * Prior diagnosis of HF, with at least one hospitalization for HF at any time. * NYHA class I-IV. * LVEF available (echocardiogram or cardiac MRI) within the last 12 months prior to enrolment. * Treatment according with contemporary guidelines recommendations and with stable doses of oral loop diuretics for at least 4 weeks * NT-proBNP \>600 pg/ml at screening (≥400 pg/ml if hospitalized for HF within the previous 12 months; ≥900 pg/ml If concomitant AF at * Screening irrespective of time to last HF hospitalization). Exclusion Criteria: * Dapagliflozin or other SGLT2i at any time in prior 6 months. * Type 1 diabetes mellitus (T1D) * Estimated glomerular filtration rate \< 30 ml/min/1.73 m2 as measured by the simplified Modification of Diet in Renal Disease (MDRD) formula at screening. * Symptomatic hypotension or systolic blood pressure (SBP) \<95 mmHg on 2 consecutive measurements at screening. * Uncontrolled hypertension, defined as SBP \>160 mmHg. * Current acute decompensated HF or hospitalization due to decompensated HF within 4 weeks prior to enrolment * The use of outpatient or inpatient i.v. diuretic therapy within 4 weeks prior to baseline. * Subjects who are currently receiving or have received inotropic agents within 12 weeks prior to baseline. * Myocardial infarction, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment * Coronary revascularization (percutaneous coronary intervention or…

What they're measuring

Change in LAVI from baseline to 6 months.

Timeframe: Up to 6 months

Trial details

NCT IDNCT04707352

SponsorFundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-03-26