Heart FailureNCT07341893
Sacubitril-valsartan in Patients With Heart Failure.
A study testing Sacubitril-valsartan and standard treatment of heart failure in people with Heart Failure, run by Damanhour University at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate the safety and efficacy of Sacubitril -Valsartan in patients with heart failure. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Sacubitril-valsartan and standard treatment of heart failure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2025to 30 Mar 2026
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old for both genders.
- LV ejection fraction (LVEF) ≤40%.
- Heart failure patients with NYHA grade II-IV.
Who cannot join
- CKD with GFR < 20 ml/min/1.73
- Serum potassium < 5.5 mmol / L.
- Pregnant or lactating women
- Active infection.
- Congenital heart disease.
- Autoimmune disorders or connective tissue disorders.
- Severe hepatic dysfunction.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Study Evaluating Efficacy and Safety Sacubitril-valsartan in Patients With Heart Failure.
The aim of this study is to evaluate the safety and efficacy of Sacubitril -Valsartan in patients with heart failure.
Read the detailed description
- A 3-month, prospective interventional study, which will include 60 patients with heart failure reduced ejection fraction, patients, will be consecutively randomized into two groups, the first group (n=30) will be given Sacubitril-valsartan twice daily and the second group (n=30) on standard treatment of heart failure.
- Approval will be obtained from Research and Ethics Committee of Faculty of Pharmacy, Damanhour University. Patients will provided written informed consent and will be checked for inclusion and exclusion criteria.
- All patients will undergo analysis of inflammatory biomarkers such as: NT-proBNP, Galectin-3 and GDF-15 at beginning of the study and after 3 months of the study.
- Echocardiography study before and after the study focusing on:
Measurement of parameters such as: Left atrial diameter (LAD), basic left ventricular dimensions (EDD and ESD), Ejection fraction (EF%).
- Follow up will be performed for assessing:
- MACE such as MI, stroke, HF, or death.
- LV Echocardiography improvements of any of basic Echo parameters.
- Assessment of New York Heart association (NYHA) class.
Outcomes: all patients will be followed up for 3 months for:
- 1ry outcomes: A.Major Adverse Cardiovascular Events (MACE) such as MI, stroke or death. B.Heart failure hospitalization C.LV Echocardiography improvements of any of basic Echo parameters such as: Left atrial diameter (LAD), basic left ventricular dimensions (EDD and ESD), Ejection fraction (EF%).
- 2ry outcomes: Change in inflammatory markers such as: NT-proBNP, GDF-15 and Galectin-3.
- Conditions
- Heart Failure
- Being tested
- Sacubitril-valsartan, standard treatment of heart failure
- Keywords
- NT-proBNP, Galectin 3, GDF-15, Sacubitril -Valsartan
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sacubitril-valsartanDrug
Also called Entresto
patients (n=30) will be given Sacubitril-valsartan 50 mg twice daily.
standard treatment of heart failureDrug
Also called Beta blockers, ACEis
Control group (n=30) on standard treatment of heart failure.
| Study group | Role | What they receive |
|---|---|---|
| Sacubitril-valsartan group | Active comparator | group (n=30) will be given Sacubitril-valsartan twice daily plus standard treatment. Receives: Drug: Sacubitril-valsartan |
| Control group | Placebo comparator | Control group (n=30) on standard treatment of heart failure. Receives: Drug: standard treatment of heart failure |
What is being measured
The primary outcome is the main question the study is designed to answer.
MACE incidence
Major Adverse Cardiovascular Events (MACE) such as MI, stroke or death.
Measured: 3 months
Ejection fraction (EF%)
Ejection fraction (EF%) improvement.
Measured: 3 months
Secondary outcomes (3)
NT-proBNP level (pg/ml)
Change in NT-proBNP level
Measured: 3 months
Galectin-3 level (pg/ml)
Change in Galectin-3 level
Measured: 3 months
GDF-15 level (pg/ml)
Change in GDF-15 level
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start1 Aug 2025
- Primary completion1 Mar 2026
- Study completion30 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 60 patients with heart failure reduced ejection fraction, patients, will be consecutively randomized into two groups, the first group (n=30) will be given Sacubitril-valsartan twice daily and the second group (n=30) on standard treatment of heart failure.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damanhour University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rehab Werida, Damanhour University
- Investigators
- Nouran A. Abu Shaara, Bachlore, Principal investigator, Damanhour University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07341893
- Sponsor's protocol ID
- sacubitril-valsartan
- Status last verified
- Apr 2026
- First submitted
- 1 Jan 2026
- Last updated
- 21 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lu H, Claggett BL, Packer M, Lam CSP, Swedberg K, Rouleau J, Zile MR, Lefkowitz M, Desai AS, Jhund P, McMurray JJV, Solomon SD, Vaduganathan M. Effects of Sacubitril/Valsartan on All-Cause Hospitalizations in Heart Failure: Post Hoc Analysis of the PARADIGM-HF and PARAGON-HF Randomized Clinical Trials. JAMA Cardiol. 2024 Nov 1;9(11):1047-1052. doi: 10.1001/jamacardio.2024.2566.
PubMed 39210725Lee YH, Lin PL, Chiou WR, Huang JL, Lin WY, Liao CT, Chung FP, Liang HW, Hsu CY, Chang HY. Combination of ivabradine and sacubitril/valsartan in patients with heart failure and reduced ejection fraction. ESC Heart Fail. 2021 Apr;8(2):1204-1215. doi: 10.1002/ehf2.13182. Epub 2021 Jan 6.
PubMed 33410280
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study Evaluating Efficacy and Safety Sacubitril-valsartan in Patients With Heart Failure.
- ClinicalTrials.gov ID
- NCT07341893
- Acronym / sponsor ID
- sacubitril-valsartan
- Conditions
- Heart Failure
- Keywords
- NT-proBNP, Galectin 3, GDF-15, Sacubitril -Valsartan
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Damanhour UniversityUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 1 Mar 2026 (actual)
- Study completion
- 30 Mar 2026 (actual)
- First posted
- 14 Jan 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 is to evaluate the safety and efficacy of Sacubitril -Valsartan in patients with heart failure.
Detailed description
- A 3-month, prospective interventional study, which will include 60 patients with heart failure reduced ejection fraction, patients, will be consecutively randomized into two groups, the first group (n=30) will be given Sacubitril-valsartan twice daily and the second group (n=30) on standard treatment of heart failure.
- Approval will be obtained from Research and Ethics Committee of Faculty of Pharmacy, Damanhour University. Patients will provided written informed consent and will be checked for inclusion and exclusion criteria.
- All patients will undergo analysis of inflammatory biomarkers such as: NT-proBNP, Galectin-3 and GDF-15 at beginning of the study and after 3 months of the study.
- Echocardiography study before and after the study focusing on:
Measurement of parameters such as: Left atrial diameter (LAD), basic left ventricular dimensions (EDD and ESD), Ejection fraction (EF%).
- Follow up will be performed for assessing:
- MACE such as MI, stroke, HF, or death.
- LV Echocardiography improvements of any of basic Echo parameters.
- Assessment of New York Heart association (NYHA) class.
Outcomes: all patients will be followed up for 3 months for:
- 1ry outcomes: A.Major Adverse Cardiovascular Events (MACE) such as MI, stroke or death. B.Heart failure hospitalization C.LV Echocardiography improvements of any of basic Echo parameters such as: Left atrial diameter (LAD), basic left ventricular dimensions (EDD and ESD), Ejection fraction (EF%).
- 2ry outcomes: Change in inflammatory markers such as: NT-proBNP, GDF-15 and Galectin-3.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 60 patients with heart failure reduced ejection fraction, patients, will be consecutively randomized into two groups, the first group (n=30) will be given Sacubitril-valsartan twice daily and the second group (n=30) on standard treatment of heart failure.
| Arm | Type | Receives |
|---|---|---|
| Sacubitril-valsartan group | Active comparator | Drug: Sacubitril-valsartangroup (n=30) will be given Sacubitril-valsartan twice daily plus standard treatment. |
| Control group | Placebo comparator | Drug: standard treatment of heart failureControl group (n=30) on standard treatment of heart failure. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years old for both genders.
- LV ejection fraction (LVEF) ≤40%.
- Heart failure patients with NYHA grade II-IV.
Key exclusion criteria (7 listed)
- CKD with GFR < 20 ml/min/1.73
- Serum potassium < 5.5 mmol / L.
- Pregnant or lactating women
- Active infection.
- Congenital heart disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sacubitril-valsartanAlso: Entrestopatients (n=30) will be given Sacubitril-valsartan 50 mg twice daily. | Drug | Sacubitril-valsartan group |
| standard treatment of heart failureAlso: Beta blockers, ACEisControl group (n=30) on standard treatment of heart failure. | Drug | Control group |
Primary outcome
MACE incidence
Time frame: 3 months
Major Adverse Cardiovascular Events (MACE) such as MI, stroke or death.
Ejection fraction (EF%)
Time frame: 3 months
Ejection fraction (EF%) improvement.
3 secondary outcomes
NT-proBNP level (pg/ml)
Time frame: 3 months
Galectin-3 level (pg/ml)
Time frame: 3 months
GDF-15 level (pg/ml)
Time frame: 3 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 21 Apr 2026.
- Background: PubMed 39210725Lu H, Claggett BL, Packer M, Lam CSP, Swedberg K, Rouleau J, Zile MR, Lefkowitz M, Desai AS, Jhund P, McMurray JJV, Solomon SD, Vaduganathan M. Effects of Sacubitril/Valsartan on All-Cause Hospitalizations in Heart Failure: Post Hoc Analysis of the PARADIGM-HF and PARAGON-HF Randomized Clinical Trials. JAMA Cardiol. 2024 Nov 1;9(11):1047-1052. doi: 10.1001/jamacardio.2024.2566.
- Background: PubMed 33410280Lee YH, Lin PL, Chiou WR, Huang JL, Lin WY, Liao CT, Chung FP, Liang HW, Hsu CY, Chang HY. Combination of ivabradine and sacubitril/valsartan in patients with heart failure and reduced ejection fraction. ESC Heart Fail. 2021 Apr;8(2):1204-1215. doi: 10.1002/ehf2.13182. Epub 2021 Jan 6.
- 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.
Nouran A. Abu Shaara, Bachlore principal investigator
Damanhour University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sacubitril-valsartan and standard treatment of heart failure in people with Heart Failure, run by Damanhour University at 1 site in Egypt.
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 7 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 21 Apr 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 Egypt. 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. Some participants in this study may receive a placebo. 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?
MACE incidence (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07341893, which also lists 2 linked publications.
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 21 Apr 2026.