Left Ventricular Diastolic FunctionNCT07157527
Impact of Sacubitril/Valsartan on LV Diastolic Function in HFrEF
An observational study of Left Ventricular Diastolic Function, run by Assiut University.
Trial summary
This prospective cohort study evaluates the effects of six months of sacubitril/valsartan (ARNI) therapy on left ventricular diastolic function in patients with heart failure with reduced ejection fraction (HFrEF) using transthoracic echocardiography. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Left Ventricular Diastolic Function
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to 30 Dec 2027
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study enrolls 70 patients characterized by a high prevalence of comorbidities including diabetes mellitus, hypertension, obesity, chronic kidney disease, dyslipidemia, and smoking, reflecting the typical clinical profile of Egyptian HFrEF patients. The median age is younger compared to Western cohorts, with patients presenting advanced heart failure symptoms and poorer functional status. Inclusion criteria require participants to tolerate and comply with ARNI therapy and exclude those with significant mitral valve disease, atrial arrhythmias, pacemakers, or poor echocardiographic windows. Comprehensive demographic and clinical data are collected, including sex, NYHA functional class, baseline medications, and heart failure subclassification. This population thus represents a real-world, high-risk group vulnerable to adverse heart failure outcomes, suitable for studying ARNI's effects on diastolic function and overall cardiac remodeling.
Who may be able to join
- Diagnosed with HFrEF (LVEF < 35%)
- Able to tolerate and comply with ARNI therapy
- Patients on Guideline-Directed Medical Therapy (GDMT) for heart failure
Who cannot join
- Patients with contraindication to ARNI therapy
- Patients with poor echocardiographic window
- Patients non-compliant with medication or follow-up
- Patients with mitral significant lesion or mitral prosthesis.
- Patients with atrial arrhythmia or on pacemaker
About this study
Official title: Impact of Sacubitril/Valsartan Therapy on Left Ventricular Diastolic Function in Patients With Heart Failure With Reduced Ejection Fraction (HFrEF): An Echocardiographic Evaluation
This prospective cohort study evaluates the effects of six months of sacubitril/valsartan (ARNI) therapy on left ventricular diastolic function in patients with heart failure with reduced ejection fraction (HFrEF) using transthoracic echocardiography. It aims to correlate echocardiographic parameters with clinical status and systolic function among Egyptian patients treated at two cardiology centers.
Read the detailed description
Heart failure remains a leading global health issue characterized by high morbidity and mortality, with a pronounced burden in Egypt due to younger patient age and prevalent comorbidities such as diabetes and hypertension. This study addresses the impact of ARNI therapy, which is established for improving systolic outcomes, on diastolic function-an underexplored aspect contributing to symptom severity and prognosis in HFrEF.
Conducted at Assiut General Hospital and Mabarra Hospital cardiology departments, the prospective cohort study enrolls adult patients (≥18 years) with HFrEF (LVEF < 35%) eligible for and initiating sacubitril/valsartan therapy. Transthoracic echocardiography assessments are performed at baseline and after six months of treatment, measuring parameters such as E/A ratio, E/e' ratio, left atrial volume index, deceleration time, and tricuspid regurgitation velocity according to ASE/EACVI guidelines.
The study also integrates clinical evaluations (NYHA class, comorbidities), ECG changes, and laboratory data. Statistical analyses include paired tests to compare changes over time, and correlations between echocardiographic and clinical/laboratory variables. Ethical approval was obtained, and patient confidentiality is assured.
This investigation aims to contribute novel insights into ARNI's effect on diastolic function in a high-risk Egyptian cohort, potentially informing optimized therapy and management of symptomatic heart failure beyond current evidence primarily focused on systolic improvements.
- Conditions
- Left Ventricular Diastolic Function
- Keywords
- Left Ventricular Diastolic Function, Sacubitril, Valsartan
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 |
|---|---|---|
| Patients receive sacubitril/valsartan as part of guideline-directed medical therapy | Patients receive sacubitril/valsartan as part of guideline-directed medical therapy. Echocardiographic, clinical, ECG, and laboratory evaluations are performed before initiation and after 6 months of continuous ARNI treatment to assess changes in cardiac function and clinical status. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Left Ventricular Diastolic Function
Assessment of echocardiographic parameters of diastolic function (E/A ratio)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2025
- Study start1 Jun 2026 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Left Ventricular Diastolic FunctionStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hebba Awd, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07157527
- Sponsor's protocol ID
- Sacubitril/Valsartan on LV
- Status last verified
- Aug 2025
- First submitted
- 28 Aug 2025
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Li J, Song Y, Chen F. Evaluating the impact of Sacubitril/valsartan on diastolic function in patients with heart failure: A systematic review and meta-analysis. Medicine (Baltimore). 2024 May 10;103(19):e37965. doi: 10.1097/MD.0000000000037965.
PubMed 38728489
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Sacubitril/Valsartan Therapy on Left Ventricular Diastolic Function in Patients With Heart Failure With Reduced Ejection Fraction (HFrEF): An Echocardiographic Evaluation
- ClinicalTrials.gov ID
- NCT07157527
- Acronym / sponsor ID
- Sacubitril/Valsartan on LV
- Conditions
- Left Ventricular Diastolic Function
- Keywords
- Left Ventricular Diastolic Function, Sacubitril, Valsartan
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 5 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 prospective cohort study evaluates the effects of six months of sacubitril/valsartan (ARNI) therapy on left ventricular diastolic function in patients with heart failure with reduced ejection fraction (HFrEF) using transthoracic echocardiography. It aims to correlate echocardiographic parameters with clinical status and systolic function among Egyptian patients treated at two cardiology centers.
Detailed description
Heart failure remains a leading global health issue characterized by high morbidity and mortality, with a pronounced burden in Egypt due to younger patient age and prevalent comorbidities such as diabetes and hypertension. This study addresses the impact of ARNI therapy, which is established for improving systolic outcomes, on diastolic function-an underexplored aspect contributing to symptom severity and prognosis in HFrEF.
Conducted at Assiut General Hospital and Mabarra Hospital cardiology departments, the prospective cohort study enrolls adult patients (≥18 years) with HFrEF (LVEF < 35%) eligible for and initiating sacubitril/valsartan therapy. Transthoracic echocardiography assessments are performed at baseline and after six months of treatment, measuring parameters such as E/A ratio, E/e' ratio, left atrial volume index, deceleration time, and tricuspid regurgitation velocity according to ASE/EACVI guidelines.
The study also integrates clinical evaluations (NYHA class, comorbidities), ECG changes, and laboratory data. Statistical analyses include paired tests to compare changes over time, and correlations between echocardiographic and clinical/laboratory variables. Ethical approval was obtained, and patient confidentiality is assured.
This investigation aims to contribute novel insights into ARNI's effect on diastolic function in a high-risk Egyptian cohort, potentially informing optimized therapy and management of symptomatic heart failure beyond current evidence primarily focused on systolic improvements.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients receive sacubitril/valsartan as part of guideline-directed medical therapy | – | –Patients receive sacubitril/valsartan as part of guideline-directed medical therapy. Echocardiographic, clinical, ECG, and laboratory evaluations are performed before initiation and after 6 months of continuous ARNI treatment to assess changes in cardiac function and clinical status. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study enrolls 70 patients characterized by a high prevalence of comorbidities including diabetes mellitus, hypertension, obesity, chronic kidney disease, dyslipidemia, and smoking, reflecting the typical clinical profile of Egyptian HFrEF patients. The median age is younger compared to Western cohorts, with patients presenting advanced heart failure symptoms and poorer functional status. Inclusion criteria require participants to tolerate and comply with ARNI therapy and exclude those with significant mitral valve disease, atrial arrhythmias, pacemakers, or poor echocardiographic windows. Comprehensive demographic and clinical data are collected, including sex, NYHA functional class, baseline medications, and heart failure subclassification. This population thus represents a real-world, high-risk group vulnerable to adverse heart failure outcomes, suitable for studying ARNI's effects on diastolic function and overall cardiac remodeling.
Key inclusion criteria (3 listed)
- Diagnosed with HFrEF (LVEF < 35%)
- Able to tolerate and comply with ARNI therapy
- Patients on Guideline-Directed Medical Therapy (GDMT) for heart failure
Key exclusion criteria (5 listed)
- Patients with contraindication to ARNI therapy
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
Change in Left Ventricular Diastolic Function
Time frame: Baseline
Assessment of echocardiographic parameters of diastolic function (E/A ratio)
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 5 Sep 2025.
- Background: PubMed 38728489Li J, Song Y, Chen F. Evaluating the impact of Sacubitril/valsartan on diastolic function in patients with heart failure: A systematic review and meta-analysis. Medicine (Baltimore). 2024 May 10;103(19):e37965. doi: 10.1097/MD.0000000000037965.
Related trials for Left Ventricular Diastolic Function
RecruitingObservational study
Novel Technologies to Improve Echocardiographic Estimates of Left Ventricular Filling Pressure in Heart Failure Combined With Atrial Fibrillation
Heart Failure (HF), Atrial Fibrillation (AF)
RecruitingPhase 2
Triple Combination Therapy (ARNI, SGLT2i, MRA) in Advanced HFpEF
HFpEF, LVDD
RecruitingObservational study
Pediatric Hypertension and the Renin-Angiotensin SystEm (PHRASE)
Hypertension, Left Ventricular Hypertrophy
Not yet recruiting
The Effect of Cardiac Rehabilitation on Left Ventricular Remodeling in Patients Undergoing Primary Percutaneous Coronary Intervention for Acute Myocardial Infarction
Acute Myocardial Infarction (AMI), PCI Patients
RecruitingObservational study
Left Ventricular Reverse Remodeling Evaluation After Surgical Correction of Aortic Regurgitation
Aortic Valve Regurgitation, Mitral Valve Regurgitation
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Left Ventricular Diastolic Function, run by Assiut University.
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 5 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: opening soon, as of the sponsor's last update on 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Change in Left Ventricular Diastolic Function (time frame: Baseline). 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 NCT07157527, which also lists 1 linked publication.
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 5 Sep 2025.