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Initiation of angiotensin receptor-neprilysin inhibitor (ARNi) and sodium-glucose cotransporter-2 inhibitors (SGLT2i) in patients with heart failure with reduced ejection fraction (HFrEF): the INITIATE-HFrEF randomized open-label trial
EU CTIS ID: 2022-502409-14-00
What this study is testing
To compare the safety of two different initiation strategies: 1) initiation of ARNi and SGLT2i simultaneously (same day or within ± 5 days) 2) sequential prescription: initial SGLT2i prescription and addition of ARNi between week 4 and 12 after randomization The null hypothesis is that: the safety of a simultaneous initiation of ARNi and a SGLT2i is non-inferior to a sequential initiation of SGLT2i first followed by an ARNi in patients with HFrEF or HFmrEF.
- Phase III and phase IV (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age ≥ 18 years
- Heart failure symptoms (NYHA II, III or IV)
- Left ventricle ejection fraction ≤ 49% (assessed by transthoracic echocardiogram)
- Glomerular filtration rate ≥ 25 ml/min/1.73m2 (CKD-EPI formula)
- Serum potassium (K+) ≤ 5.4 mmol/L
- Systolic blood pressure ≥ 100 mmHg
You likely can't join if
- Involvement in the planning and/or conduct of the study (applies to both Investigator staff and/or staff at the study site)
- Previously confirmed cardiac amyloidosis
- History of angioedema
- Implantable cardioverter-defibrillators or cardiac resynchronization therapy within 3 months prior to screening or if there is an intent to implant either device in the 3 months following screening
- Female patients currently pregnant (confirmed by a positive pregnancy test) or intent to become pregnant or breast feeding
- Severe valvulopathy according to the echocardiogram report
See the full eligibility criteria
- Age ≥ 18 years
- Heart failure symptoms (NYHA II, III or IV)
- Left ventricle ejection fraction ≤ 49% (assessed by transthoracic echocardiogram)
- Glomerular filtration rate ≥ 25 ml/min/1.73m2 (CKD-EPI formula)
- Serum potassium (K+) ≤ 5.4 mmol/L
- Systolic blood pressure ≥ 100 mmHg
- 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, female patient of non-childbearing potential (detailed in full protocol)
- If female patient of childbearing potential, she must have a negative serum pregnancy test at Visit 1 (Day 0) and must agree to use one highly effective method of contraception (detailed in full protocol) consistently and correctly
- Involvement in the planning and/or conduct of the study (applies to both Investigator staff and/or staff at the study site)
- Previously confirmed cardiac amyloidosis
- History of angioedema
- Implantable cardioverter-defibrillators or cardiac resynchronization therapy within 3 months prior to screening or if there is an intent to implant either device in the 3 months following screening
- Female patients currently pregnant (confirmed by a positive pregnancy test) or intent to become pregnant or breast feeding
- Severe valvulopathy according to the echocardiogram report
- Previous history of ketoacidosis due to SGLT2i
- 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)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.