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

NCT07465679 | Active Not Recruiting

• 1 other identifier: CLCZ696BRO01
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Heart Failure With Reduced Ejection Fraction

Keywords

HFrEF; Sacubitril/valsartan; Guidelines; Romania

Outcome Measures

Primary Outcomes (1)

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

  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 Outcomes (9)

• Percentage of Patients by Demographic Category

  Up to approximately 5 years and 6 months

• Percentage of Patients by Clinical Characteristic Category

  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

  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

Study Arms (1)

Sacubitril/Valsartan Cohort

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis

Bucharest, 020334, Romania

Location

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2026
• First Posted: March 12, 2026
• Study Start: January 28, 2026
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

RO (1)