Dapagliflozin on Volume Vascular Outcomes.

• Status: Recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the DAPA-VOLVO trial is to investigate the effects of Dapagliflozin on top of recommended standard therapy on volume status and vascular function in clinically stable heart failure patients after hospitalization because of an acute decompensated heart failure event.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Frank Ruschitzka
• Collaborator: AstraZeneca
• Treatments: 2-(3-(4-ethoxybenzyl)-4-chlorophenyl)-6-hydroxymethyltetrahydro-2H-pyran-3,4,5-triol; Dapagliflozin

Criteria

Inclusion Criteria:

• Provision of signed informed consent;

• Male or female, age of 18 or older;

• Patients with documented diagnosis of heart failure (NYHA II-IV) and clinically stabilized (considered for hospital discharge) after hospitalization because of an acute decompensated (congestive) heart failure (ADHF) event;

• eGFR ≥ 30 mL/min/1.73 m2 (CKD-EPI formula) at enrolment;

Exclusion Criteria:

• Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product;

• Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor;

• Participation in another study with investigational drug within the 30 days preceding and during the present study;

• Type 1 diabetes mellitus;

• Symptomatic hypotension or systolic blood pressure <90 mmHg at 2 out of 3 measurements either at visit 1 or visit 2;

• Coronary revascularization (percutaneous coronary intervention because of STEMI or coronary artery bypass grafting) or valvular repair/replacement within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization;

• Implantation of a CRT device within 12 weeks prior to enrolment or intent to implant a CRT device during 12 weeks of study observation period if indicated according to the actual guidelines [Ponikowski P et al. 2016];

• Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization;

• 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;

• Severe (eGFR < 20 mL/min/1.73 m2 by CKD-EPI), unstable or rapidly progressing renal disease at the time of randomization;

• Women who are pregnant or breast feeding;

• Intention to become pregnant during the course of the study;

• Known or suspected non-compliance, drug or alcohol abuse;

• Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant;

• Patients with severely restricted liver function;

• Patients with recurrent mycotic genital infections;