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Completed

NCT Number: NCT07465679

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

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.

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Key information

Conditions

Heart Failure With Reduced Ejection Fraction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis

Bucharest, 020334, Romania

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Percentage of Patients Receiving all Four Guideline-recommended Therapeutic Classes for HFrEF

    Time frame: 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 outcomes

  1. Percentage of Patients by Demographic Category

    Time frame: Up to approximately 5 years and 6 months

    Demographics include age group and sex.

  2. Percentage of Patients by Clinical Characteristic Category

    Time frame: Up to approximately 5 years and 6 months

    Clinical characteristics include treating physician specialty, diagnosis, comorbidities, and concomitant medications.

  3. Percentage of Patients Who Used Angiotensin-converting Enzyme (ACE) Inhibitors and/or Angiotensin Receptor Blockers Before Starting Sacubitril/Valsartan Treatment

    Time frame: Up to approximately 5 years and 6 months

  4. Percentage of Patients by Sacubitril/Valsartan Prescribed Dose at Treatment Initiation

    Time frame: Baseline

  5. Percentage of Patients by Dosing Frequency

    Time frame: Up to approximately 5 years and 6 months

  6. Duration of Sacubitril/Valsartan Treatment

    Time frame: Up to approximately 5 years and 6 months

  7. Percentage of Patients by Use of Individual Guideline-recommended Pharmacological Therapeutic Classes for HFrEF

    Time frame: Up to approximately 5 years and 6 months

    Guideline-recommended pharmacological therapeutic classes for HFrEF include beta-blockers, mineralocorticoid receptor antagonists, and SGLT2 inhibitors.

  8. Percentage of Patients by Most Frequently Prescribed Concomitant Cardiovascular Medications

    Time frame: Up to approximately 5 years and 6 months

  9. Number of Concomitant Cardiovascular Medications

    Time frame: Up to approximately 5 years and 6 months

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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)

Acronym: REACT-HFrEF-RO

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 12, 2026
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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