Ertugliflozin to Reduce Arrhythmic burden in ICD/CRT patientS

Phase 1

• Conditions: Heart failure; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2020-002581-14-AT
• Lead Sponsor: Medical University of Graz, Division of Cardiology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-09-02
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 402

Inclusion Criteria

1) HFrEF or HFmrEF and ICD±CRT therapy > 3 months
2) Least 10 documented VT episodes (either nsVT or sVT ± ICD treatment) within the last 12 months plus
- nt-proBNP > 500pg/mL or
- LV-EF < 35% or
- hospitalization for heart failure within the last 12 months or
- >100nsVTs within the last 12 months- > 1 sVT/VF within the last 12 months
3) Informed consent has to be given in written form.
4) eGFR > 30 ml/min/1.73m2
5) Blood pressure before first drug dosing: RRsystolic >100mmHg
6) Blood pressure before first drug dosing: RRdiastolic >60mmHg
7) 18 – 80 years of age

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 201
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 201

Exclusion Criteria

1) Any other form of diabetes mellitus than type 2 diabetes mellitus, history of diabetic ketoacidosis
2) Ongoing ventricular arrhythmia
3) Known allergy to SGLT-2 inhibitors
4) Hemodynamic instability as defined by intravenous administration of catecholamine, calcium-sensitizers or phosphodiesterase inhibitors
5) >1 episode of severe hypoglycemia within the last 6 months under treatment with insulin or sulfonylurea
6) Planned catheter ablation for ventricular arrhythmia within upcoming 12 months
7) Planned explantation of ICD, or planned up/downgrade to/from CRT-D device within upcoming 12 months
8) Existing therapy with SGLT-2 inhibitors

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified