Initiation of ARNi and SGLT2i in Patients With HFrEF (NCT05989503) | Clinical Trial Compass
CompletedPhase 4
Initiation of ARNi and SGLT2i in Patients With HFrEF
Portugal62 participantsStarted 2023-08-04
Plain-language summary
Heart failure (HF) is a condition in which the heart does not contract ("pump") or relax well, leading to insufficient perfusion of vital organs. Ankle swelling, fatigue, and breathlessness are some of the features of this syndrome. There are different causes for HF (e.g., infarct and hypertension) and two distinct types: HFpEF - HF with preserved ejection fraction - the heart "pumps" but does not relax well and HFrEF/HFmrEF - HF with reduced or mildly reduced ejection fraction - where the heart does not "pump" properly, here referred to as having HFrEF.
Patients with HFrEF experience substantially shorter life expectancies compared with people in the general population of similar age. Compared to the different available therapeutics for HFrEF patients, angiotensin receptor-neprilysin inhibitor (ARNi), sacubitril/valsartan, has shown superiority for improving clinical outcomes. Furthermore, the new recently drug sodium-glucose cotransporter 2 inhibitor (SGLT2i) was proven to reduce mortality and morbidity on top of well-adapted background therapy.
This work aims to test the safety of ARNi and SGLT2i initiation by comparing a strategy of simultaneous initiation of ARNi and SGLT2i versus sequential initiation of a SGLT2i first followed by an ARNi.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age ≥ 18 years
✓. Heart failure symptoms (NYHA II, III or IV)
✓. Left ventricle ejection fraction ≤ 49% (assessed by transthoracic echocardiogram)
✓. Not treated with ARNi nor with SGLT2i within the previous month (30 days before inclusion, except if initiated 5 days before randomization; patients treated with an ACEi or ARB can be included and maintain their therapy until the switch to an ARNi is performed)
✓. If female, she must not be a woman of childbearing potential. That is, she must be:
Exclusion criteria
✕. Involvement in the planning and/or conduct of the study (applies to both Investigator staff and/or staff at the study site)
What they're measuring
1
Composite outcome (time-to-first event' occurrence during the 6 months of follow-up):
. Participation in another clinical study with an investigational product during the last month
✕. Unwilling to sign inform consent
✕. Patients with a known hypersensitivity or intolerance to ARNi or SGLT2i or any of the excipients of the products
✕. Hospitalization due to non-cardiovascular causes, surgical procedure, coronary, cerebral or peripheral vascular events or sepsis in the prior month
✕. Cancer (life limiting with an estimated life expectancy of less than 2 years based on investigator's judgement)