Heart Failure With Reduced Ejection FractionREACT-HFrEF-RONCT07465679
A Real-world Study of Clinical Treatment Guidelines for Patients With Heart Failure With Reduced Ejection Fraction Treated With Sacubitril/Valsartan
An observational study of Heart Failure With Reduced Ejection Fraction, run by Novartis Pharmaceuticals at 1 site in Romania.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure With Reduced Ejection Fraction
- How many people
- 2,508 participants
- Where
- 1 siteRomania
- Study dates
- 28 Jan 2026to 10 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with HFrEF and at least one prescription of sacubitril/valsartan.
Who may be able to join
- A recorded diagnosis of HFrEF.
- At least one prescription of sacubitril/valsartan during the identification period.
- Age ≥18 years at the index date.
Who cannot join
- Patients who do not meet inclusion criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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)
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.
- Keywords
- HFrEF, Sacubitril/valsartan, Guidelines, Romania
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Sacubitril/Valsartan Cohort | Adults with a recorded diagnosis of HFrEF and ≥1 prescription of sacubitril/valsartan during the study period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to approximately 5 years and 6 months
Secondary outcomes (9)
Percentage of Patients by Demographic Category
Demographics include age group and sex.
Measured: Up to approximately 5 years and 6 months
Percentage of Patients by Clinical Characteristic Category
Clinical characteristics include treating physician specialty, diagnosis, comorbidities, and concomitant medications.
Measured: 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
Measured: Up to approximately 5 years and 6 months
Percentage of Patients by Sacubitril/Valsartan Prescribed Dose at Treatment Initiation
Measured: Baseline
Percentage of Patients by Dosing Frequency
Measured: Up to approximately 5 years and 6 months
Duration of Sacubitril/Valsartan Treatment
Measured: Up to approximately 5 years and 6 months
Percentage of Patients by Use of Individual Guideline-recommended Pharmacological Therapeutic Classes for HFrEF
Guideline-recommended pharmacological therapeutic classes for HFrEF include beta-blockers, mineralocorticoid receptor antagonists, and SGLT2 inhibitors.
Measured: Up to approximately 5 years and 6 months
Percentage of Patients by Most Frequently Prescribed Concomitant Cardiovascular Medications
Measured: Up to approximately 5 years and 6 months
Number of Concomitant Cardiovascular Medications
Measured: Up to approximately 5 years and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start28 Jan 2026
- Primary completion10 Mar 2026
- Study completion10 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Reduced Ejection FractionStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,508 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07465679
- Sponsor's protocol ID
- CLCZ696BRO01
- Acronym
- REACT-HFrEF-RO
- Status last verified
- Jul 2026
- First submitted
- 6 Mar 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT07465679
- Acronym / sponsor ID
- REACT-HFrEF-RO / CLCZ696BRO01
- Keywords
- HFrEF, Sacubitril/valsartan, Guidelines, Romania
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,508 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 28 Jan 2026 (actual)
- Primary completion
- 10 Mar 2026 (actual)
- Study completion
- 10 Mar 2026 (actual)
- First posted
- 12 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sacubitril/Valsartan Cohort | – | –Adults with a recorded diagnosis of HFrEF and ≥1 prescription of sacubitril/valsartan during the study period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with HFrEF and at least one prescription of sacubitril/valsartan.
Key inclusion criteria (3 listed)
- A recorded diagnosis of HFrEF.
- At least one prescription of sacubitril/valsartan during the identification period.
- Age ≥18 years at the index date.
Key exclusion criteria (1 listed)
- Patients who do not meet inclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
9 secondary outcomes
Percentage of Patients by Demographic Category
Time frame: 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
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
Percentage of Patients by Sacubitril/Valsartan Prescribed Dose at Treatment Initiation
Time frame: Baseline
Percentage of Patients by Dosing Frequency
Time frame: Up to approximately 5 years and 6 months
Duration of Sacubitril/Valsartan Treatment
Time frame: 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
Percentage of Patients by Most Frequently Prescribed Concomitant Cardiovascular Medications
Time frame: Up to approximately 5 years and 6 months
Number of Concomitant Cardiovascular Medications
Time frame: Up to approximately 5 years and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure With Reduced Ejection Fraction, run by Novartis Pharmaceuticals at 1 site in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Patients Receiving all Four Guideline-recommended Therapeutic Classes for HFrEF (time frame: Up to approximately 5 years and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.