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

March 6, 2026 updated by: Novartis Pharmaceuticals

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)

The aim of this study is 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 uses secondary use of data, with all analyses conducted on anonymized, pre-existing data collected for routine clinical and administrative purposes.

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Romania
      • Bucharest, Romania, 020334
        • Novartis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients with HFrEF and at least one prescription of sacubitril/valsartan.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Sacubitril/Valsartan Cohort
Adults with a recorded diagnosis of HFrEF and ≥1 prescription of sacubitril/valsartan during the study period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to approximately 5 years and 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Patients by Demographic Category
Time Frame: Up to approximately 5 years and 6 months
Demographics include age group and sex.
Up to approximately 5 years and 6 months
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.
Up to approximately 5 years and 6 months
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
Up to approximately 5 years and 6 months
Percentage of Patients by Sacubitril/Valsartan Prescribed Dose at Treatment Initiation
Time Frame: Baseline
Baseline
Percentage of Patients by Dosing Frequency
Time Frame: Up to approximately 5 years and 6 months
Up to approximately 5 years and 6 months
Duration of Sacubitril/Valsartan Treatment
Time Frame: Up to approximately 5 years and 6 months
Up to approximately 5 years and 6 months
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.
Up to approximately 5 years and 6 months
Percentage of Patients by Most Frequently Prescribed Concomitant Cardiovascular Medications
Time Frame: Up to approximately 5 years and 6 months
Up to approximately 5 years and 6 months
Number of Concomitant Cardiovascular Medications
Time Frame: Up to approximately 5 years and 6 months
Up to approximately 5 years and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Investigators

  • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 28, 2026

Primary Completion (Estimated)

March 31, 2026

Study Completion (Estimated)

March 31, 2026

Study Registration Dates

First Submitted

March 6, 2026

First Submitted That Met QC Criteria

March 6, 2026

First Posted (Actual)

March 12, 2026

Study Record Updates

Last Update Posted (Actual)

March 12, 2026

Last Update Submitted That Met QC Criteria

March 6, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CLCZ696BRO01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Heart Failure With Reduced Ejection Fraction

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in France

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe