Status:
COMPLETED
Initiation of ARNi and SGLT2i in Patients With HFrEF
Lead Sponsor:
Universidade do Porto
Collaborating Sponsors:
Unidade de Investigação e Desenvolvimento Cardiovascular (UnIC)
Rede de Investigação em Saúde
Conditions:
Heart Failure With Reduced Ejection Fraction
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 o...
Detailed Description
Sacubitril/valsartan and SGLT2i reduced HF hospitalizations and mortality in patients with heart failure and a reduced ejection fraction with a rapid onset of action, but the timing of initiation of e...
Eligibility Criteria
Inclusion
- 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, she must not be a woman of childbearing potential. That is, she must be:
- Surgically sterilized (e.g., underwent hysterectomy, bilateral salpingectomy or bilateral oophorectomy)
- Clinically diagnosed infertile
- In a post-menopausal state, defined as no menses for 12 months without an alternative medical cause
- If female patient of childbearing potential, she must have a negative serum pregnancy test at Visit 1 (Day 0) and must agree to consistently and correctly use (from 28 days prior to first study treatment administration until at least 7 days after last study treatment administration) one of the following highly effective methods of contraception:
- Abstinence of heterosexual intercourse (when this is in line with preferred and usual lifestyle of the subject)
- Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable)
- Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal)
- Intrauterine device
- Intrauterine hormone-releasing system
- Bilateral tubal occlusion
- Vasectomized partner, who has received medical assessment of the surgical success, or clinically diagnosed infertile partner
Exclusion
- Involvement in the planning and/or conduct of the study (applies to both Investigator staff and/or staff at the study site)
- 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)
- 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
Key Trial Info
Start Date :
August 4 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2025
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT05989503
Start Date
August 4 2023
End Date
July 31 2025
Last Update
November 19 2025
Active Locations (5)
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1
Centro Hospitalar Universitário de Santo António
Porto, Porto District, Portugal, 4099-001
2
Centro Hospitalar Universitário São João
Porto, Portugal, 4200-319
3
Faculty of Medicine (FMUP)
Porto, Portugal, 4200-319
4
Centro Hospitalar Vila Nova de Gaia/Espinho
Porto, Portugal, 4434-502