Status:
COMPLETED
Impact on Atrial Remodeling of Dapaglifozin in Patients With Heart Failure .
Lead Sponsor:
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Collaborating Sponsors:
Spanish Society of Cardiology
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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 coronary artery bypass grafting or valvular repair/replacement within 12 weeks prior to enrolment or planned to undergo any of these operations after inclusion
- Implantation of a cardiac resynchronization therapy (CRT) within 12 weeks prior to enrolment or intent to implant a CRT device
- Previous cardiac transplantation or implantation of a ventricular assistance device (VAD) or similar device, or implantation expected after inclusion
- HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease
- Symptomatic bradycardia or second or third degree heart block without a pacemaker
- History of allergic reactions or intolerance to dapagliflozin, or other iSGLT2, or any other compound
- History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within one year.
- Hepatic impairment aspartate transaminase \[AST\] or alanine transaminase \[ALT\] \>3x the upper limit of normal \[ULN\]; or total bilirubin \>2x ULN at time of screening)
- Women of child-bearing potential (ie, those who are not chemically or surgically sterilised or who are not post-menopausal) who are not willing to use a medically accepted method of contraception that is considered reliable in the judgment of the investigator or women who have a positive pregnancy test at enrollment or randomization or women who are breast-feeding
- Participation in another clinical trial during the last month prior to enrolment
- Inability of the patient, in the opinion of the investigator, to understand and/or comply with study medications, procedures and/or follow-up or any conditions that, in the opinion of the investigator, may render the patient unable to complete the study
- Any concomitant disease limiting life expectancy in the following year (other than heart failure)
- No possibility to give informed consent.
Key Trial Info
Start Date :
February 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 26 2023
Estimated Enrollment :
162 Patients enrolled
Trial Details
Trial ID
NCT04707352
Start Date
February 8 2021
End Date
March 26 2023
Last Update
July 12 2023
Active Locations (1)
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1
Hospital Clinico Universitario Virgen de la Arrixaca
Murcia, Spain, 30003