Sacubitril/ValsartanNCT07192341
Sacubitril/Valsartan in Patients With Prosthetic Heart Valves With Heart Failure and Reduced Ejection Fraction
A study testing Sacubitril/Valsartan and Conventional anti-heart failure therapy in people with Sacubitril/Valsartan and Prosthetic Heart Valve, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
This study aims to evaluate the effect of sacubitril/valsartan in patients with prosthetic heart valves with heart failure with reduced ejection fraction (HFrEF). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sacubitril/Valsartan, Prosthetic Heart Valve, Heart Failure
- What is being tested?
- Sacubitril/Valsartan and Conventional anti-heart failure therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteEgypt
- Study dates
- 27 Sep 2025to 1 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Age ≥ 18 years old.
- Both sexes.
- Patients with a history of prosthetic heart valves.
- Patients diagnosed with heart failure with reduced ejection fraction (HFrEF), defined as left ventricular ejection fraction (LVEF) ≤ 40% with New York Heart Association (NYHA) functional class II-IV.
Who cannot join
- Hemodynamic instability.
- Use of a circulatory auxiliary circulation device.
- Severe hepatic [alanine aminotransferase (ALT) >120 U/L] and renal insufficiency [estimated glomerular filtration rate (eGFR) <30 mL/min].
- Blood pressure <100/60 mmHg.
- Serum potassium >5.3 mmol/L.
- Severe pulmonary hypertension.
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- Malignant arrhythmia.
- Malignant tumor.
- Known history of hereditary or primary angioedema.
- Serious adverse drug reactions or serious complications over the course of treatment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Kafrelsheikh University
Kafr ash Shaykh, Kafrelsheikh, 33516
Mohammed A Hammad, MD, 00201015928694, drhammad879@gmail.com
Wael A Hassib, MD
About this study
Official title: Effect of Sacubitril/Valsartan in Patients With Prosthetic Heart Valves With Heart Failure and Reduced Ejection Fraction
This study aims to evaluate the effect of sacubitril/valsartan in patients with prosthetic heart valves with heart failure with reduced ejection fraction (HFrEF).
Read the detailed description
Heart failure (HF) is the end stage of various types of cardiovascular disease. The prevalence of HF continues to rise, and the rates of readmission and mortality also continue to increase significantly.
There are three types of HF, heart failure with preserved ejection fraction (HFpEF), heart failure with mid-range ejection fraction (HFmrEF), and heart failure with reduced ejection fraction (HFrEF).
Sacubitril/valsartan, the first angiotensin receptor-neprilysin inhibitor (ARNI) approved by the FDA for the treatment of HFrEF, demonstrated significant benefits in the PARADIGM-HF trial. PARADIGM-HF trial was a large multicenter, randomized clinical trial comparing sacubitril/ valsartan with enalapril in patients with LVEF < 40%. This trial showed 20% reduction in composite Cardiovascular (CV) death (including sudden cardiac death) and hospitalization for HF patients with S/V.
- Being tested
- Sacubitril/Valsartan, Conventional anti-heart failure therapy
- 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
Patients will be treated with conventional anti-heart failure therapy plus sacubitril/valsartan (oral administration of an initial dose of 24/26 mg twice daily, gradually increasing to 97/103 mg, depending on follow-up blood pressure) [Entresto, 100 mg (sacubitril 49 mg/valsartan 51 mg)].
Conventional anti-heart failure therapyDrug
Patients will be treated only with conventional anti-heart failure therapy as a control group.
| Study group | Role | What they receive |
|---|---|---|
| Group S | Experimental | Patients will be treated with conventional anti-heart failure therapy plus sacubitril/valsartan (oral administration of an initial dose of 24/26 mg twice daily, gradually increasing to 97/103 mg, depending on follow-up blood pressure) [Entresto, 100 mg (sacubitril 49 mg/valsartan 51 mg)]. Receives: Drug: Sacubitril/Valsartan |
| Group C | Active comparator | Patients will be treated only with conventional anti-heart failure therapy as a control group. Receives: Drug: Conventional anti-heart failure therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effective rate
Effectiveness is defined as an New York Heart Association (NYHA) cardiac function grade improved by 1 grade or more.
Effective rate= Effectiveness/total quantity*(100%).
Measured: 6 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2025
- Study start27 Sep 2025
- Primary completion1 Feb 2026 (estimated)
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sacubitril/ValsartanStudies of the same condition, open and under way.
- More trials run by Kafrelsheikh UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Ali Mohammed Hammad, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07192341
- Sponsor's protocol ID
- KFSIRB200-728
- Status last verified
- Sep 2025
- First submitted
- 17 Sep 2025
- Last updated
- 30 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sacubitril/Valsartan in Patients With Prosthetic Heart Valves With Heart Failure and Reduced Ejection Fraction
- ClinicalTrials.gov ID
- NCT07192341
- Acronym / sponsor ID
- KFSIRB200-728
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 27 Sep 2025 (actual)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 25 Sep 2025 (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.
This study aims to evaluate the effect of sacubitril/valsartan in patients with prosthetic heart valves with heart failure with reduced ejection fraction (HFrEF).
Detailed description
Heart failure (HF) is the end stage of various types of cardiovascular disease. The prevalence of HF continues to rise, and the rates of readmission and mortality also continue to increase significantly.
There are three types of HF, heart failure with preserved ejection fraction (HFpEF), heart failure with mid-range ejection fraction (HFmrEF), and heart failure with reduced ejection fraction (HFrEF).
Sacubitril/valsartan, the first angiotensin receptor-neprilysin inhibitor (ARNI) approved by the FDA for the treatment of HFrEF, demonstrated significant benefits in the PARADIGM-HF trial. PARADIGM-HF trial was a large multicenter, randomized clinical trial comparing sacubitril/ valsartan with enalapril in patients with LVEF < 40%. This trial showed 20% reduction in composite Cardiovascular (CV) death (including sudden cardiac death) and hospitalization for HF patients with S/V.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group S | Experimental | Drug: Sacubitril/ValsartanPatients will be treated with conventional anti-heart failure therapy plus sacubitril/valsartan (oral administration of an initial dose of 24/26 mg twice daily, gradually increasing to 97/103 mg, depending on follow-up blood pressure) [Entresto, 100 mg (sacubitril 49 mg/valsartan 51 mg)]. |
| Group C | Active comparator | Drug: Conventional anti-heart failure therapyPatients will be treated only with conventional anti-heart failure therapy as a control group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years old.
- Both sexes.
- Patients with a history of prosthetic heart valves.
- Patients diagnosed with heart failure with reduced ejection fraction (HFrEF), defined as left ventricular ejection fraction (LVEF) ≤ 40% with New York Heart Association (NYHA) functional class II-IV.
Key exclusion criteria (10 listed)
- Hemodynamic instability.
- Use of a circulatory auxiliary circulation device.
- Severe hepatic [alanine aminotransferase (ALT) >120 U/L] and renal insufficiency [estimated glomerular filtration rate (eGFR) <30 mL/min].
- Blood pressure <100/60 mmHg.
- Serum potassium >5.3 mmol/L.
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/ValsartanPatients will be treated with conventional anti-heart failure therapy plus sacubitril/valsartan (oral administration of an initial dose of 24/26 mg twice daily, gradually increasing to 97/103 mg, depending on follow-up blood pressure) [Entresto, 100 mg (sacubitril 49 mg/valsartan 51 mg)]. | Drug | Group S |
| Conventional anti-heart failure therapyPatients will be treated only with conventional anti-heart failure therapy as a control group. | Drug | Group C |
Primary outcome
Effective rate
Time frame: 6 months post-procedure
Effectiveness is defined as an New York Heart Association (NYHA) cardiac function grade improved by 1 grade or more. Effective rate= Effectiveness/total quantity*(100%).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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Real-world Effectiveness and Safety of Savagen (Sacubitril/Valsartan) in Malaysian HFrEF Patients
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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.
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 Conventional anti-heart failure therapy in people with Sacubitril/Valsartan and Prosthetic Heart Valve, run by Kafrelsheikh 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 4 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 30 Sep 2025. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohammed A Hammad, MD (00201015928694, drhammad879@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effective rate (time frame: 6 months post-procedure). 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 30 Sep 2025.