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To evaluate the clinical and echocardiographic outcome of LCZ696 therapy in HFrEF (NYHA Class II - IV and EF =≤ 40%).patients, in addition to the efficacy of LCZ696 in reducing mortality and rehospitalisation rate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single group study |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LCZ 696 | Drug | LCZ696 is an Angiotensin receptor neprilysin inhibitor. It's composed of Sacubitril/Valsartan. LCZ696 starting dose 50 mg P.O. BID, LCZ696 100 mg P.O. BID and up-titration to LCZ696 200 mg P.O. BID. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants That Had Either Cardiovascular (CV) Death or Heart Failure (HF) Hospitalization. | Number of participants that had either CV death or HF hospitalization due to HF. | 6 Months after starting LCZ696 Therapy |
| Change From Baseline to Month 6 for The Minnesota Living with Heart Failure Questionnaire (MLHFQ). | Change From Baseline to Month 6 for the Minnesota Living with Heart Failure Questionnaire (MLHFQ). The questionnaire was designed as a self-administered measure of the effects of heart failure and treatments for heart failure on patients' quality of life. The questionnaire has 21 items assess the impact of frequent physical symptoms of heart failure and the effects of heart failure on physical and social functions. The response scale for all 21 items on the MLHF is based on a 6-point ( from 0 to 5 ). Scores are transformed to a range of 0-105, in which higher scores reflect better health status. | 6 Months after starting LCZ696 Therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients - All-cause Mortality. | Number of patients - All-cause mortality. All-cause mortality is common in HF patients. | 6 Months after starting LCZ696 Therapy |
| Number of Patients With First Confirmed Renal Dysfunction. |
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Inclusion Criteria:
Exclusion Criteria:
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Any Patients with HFrEF (EF ≤ 40%) above 18 year old.
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| Name | Affiliation | Role |
|---|---|---|
| Magdy Abdelhamid, MD, FACC, FESC, FSCAI | Professor of Cardiovascular Medicine, Cairo University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cairo University | Cairo | Egypt |
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| ID | Term |
|---|---|
| C549068 | sacubitril and valsartan sodium hydrate drug combination |
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Number of patients with first confirmed renal dysfunction ( a decrease in the eGFR of at least 50% or a decrease of more than 30 ml per minute per 1.73 m2 to less than 60 ml per minute per 1.73 m2 ).
| 6 Months after starting LCZ696 Therapy |
| Number of Patients with Changes in The Left Ventricular Systolic Function (EF). | Number of Patients with improvement in the ejection fraction. | 6 Months after starting LCZ696 Therapy |