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NCT05989503: INITIATE
Initiation of ARNi and SGLT2i in Patients With HFrEF
Phase 4 trial testing Sacubitril-valsartan in Heart Failure With Reduced Ejection Fraction in 62 participants. Completed in 31 July 2025.
31 July 2025
Quick facts
| Lead sponsor | Universidade do Porto |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 62 |
| Start date | 4 August 2023 |
| Primary completion | 31 July 2025 |
| Estimated completion | 31 July 2025 |
| Sites | 5 locations across Portugal |
Drugs / interventions tested
- Sacubitril-valsartan — full drug profile →
- SGLT2 inhibitor — full drug profile →
Conditions studied
- Heart Failure With Reduced Ejection Fraction — all drugs for Heart Failure With Reduced Ejection Fraction →
Sponsor
Universidade do Porto — full company profile →
Who can join
18 and older, any sex, with Heart Failure With Reduced Ejection Fraction. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Use of Sodium-Glucose Cotransporter 2 Inhibitors in Hospitalized Patients.
Unlu O, Bhatt AS, Blood AJ. · · 2024 · cited 6× · PMID 39129982 · DOI 10.1016/j.jacadv.2024.101024 -
Design, Rationale, and Methods of the INITIATE-HFrEF Trial : ARNI and SGLT2 Inhibitors Sequencing in HFrEF
Ferreira J, Oliveira A, Saraiva F, Pereira-Sousa I, et al · · 2026
Verify or expand the search:
- PubMed search for NCT05989503
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Sacubitril-valsartan
Trials testing the same drug.
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- NCT05498181 — Angiotensin-Neprilysin Inhibition in Hemodialysis Initiation · Phase 2 · recruiting
- NCT05194111 — Treating Heart Dysfunction Related to Cancer Therapy With Sacubitril/Valsartan · Phase 1, PHASE2 · recruiting
Other recruiting trials for Heart Failure With Reduced Ejection Fraction
Currently open trials in the same condition.
- NCT07465653 — A Safety and Tolerability Study of HJB647 in Heart Failure Participants With Reduced Ejection Fraction · Phase 1 · recruiting
- NCT07465679 — A Real-world Study of Clinical Treatment Guidelines for Patients With Heart Failure With Reduced Ejection Fraction Treat · active not recruiting
- NCT07275931 — Digital Support Program for Patients With Heart Failure - a Cluster-Randomized Hybrid Type 2 Study · NA · recruiting
- NCT06942221 — Digital Solutions in Heart Therapy (DIGNITY) · NA · recruiting
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Other Universidade do Porto trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05989503 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Universidade do Porto
- Last refreshed: 19 November 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05989503.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing