A Real-world Study of Clinical Treatment Guidelines for Patients With Heart Failure With Reduced Ejection Fraction Treated With Sacubitril/Valsartan

Real-world Adoption of Clinical Treatment Guidelines for Patients With Heart Failure With Reduced Ejection Fraction in Treatment With Entresto in Romania (REACT-HFrEF-RO)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07465679

Acronym

REACT-HFrEF-RO

Enrollment

2508

Registered

2026-03-12

Start date

2026-01-28

Completion date

2026-03-10

Last updated

2026-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure With Reduced Ejection Fraction

Keywords

HFrEF, Sacubitril/valsartan, Guidelines, Romania

Brief summary

The aim of this study was to describe the real-world clinical profile, treatment patterns, and guideline alignment of patients with heart failure with reduced ejection fraction (HFrEF) treated with sacubitril/valsartan in routine clinical practice in Romania. The study used secondary use of data, with all analyses conducted on anonymized, pre-existing data collected for routine clinical and administrative purposes.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* A recorded diagnosis of HFrEF. * At least one prescription of sacubitril/valsartan during the identification period. * Age ≥18 years at the index date.

Exclusion criteria

• Patients who do not meet inclusion criteria.

Design outcomes

Primary

Measure	Time frame	Description
Percentage of Patients Receiving all Four Guideline-recommended Therapeutic Classes for HFrEF	Up to approximately 5 years and 6 months	The four guideline-recommended therapeutic classes include sacubitril/valsartan, beta-blockers, mineralocorticoid receptor antagonists, and sodium-glucose cotransporter-2 (SGLT2) inhibitors.

Secondary

Measure	Time frame	Description
Percentage of Patients by Demographic Category	Up to approximately 5 years and 6 months	Demographics include age group and sex.
Percentage of Patients by Clinical Characteristic Category	Up to approximately 5 years and 6 months	Clinical characteristics include treating physician specialty, diagnosis, comorbidities, and concomitant medications.
Percentage of Patients Who Used Angiotensin-converting Enzyme (ACE) Inhibitors and/or Angiotensin Receptor Blockers Before Starting Sacubitril/Valsartan Treatment	Up to approximately 5 years and 6 months	—
Percentage of Patients by Sacubitril/Valsartan Prescribed Dose at Treatment Initiation	Baseline	—
Percentage of Patients by Dosing Frequency	Up to approximately 5 years and 6 months	—
Duration of Sacubitril/Valsartan Treatment	Up to approximately 5 years and 6 months	—
Percentage of Patients by Use of Individual Guideline-recommended Pharmacological Therapeutic Classes for HFrEF	Up to approximately 5 years and 6 months	Guideline-recommended pharmacological therapeutic classes for HFrEF include beta-blockers, mineralocorticoid receptor antagonists, and SGLT2 inhibitors.
Percentage of Patients by Most Frequently Prescribed Concomitant Cardiovascular Medications	Up to approximately 5 years and 6 months	—
Number of Concomitant Cardiovascular Medications	Up to approximately 5 years and 6 months	—

Countries

Romania

Contacts

STUDY_DIRECTORNovartis Pharmaceuticals

Novartis Pharmaceuticals

Outcome results