Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 5:29 AM
Study NCT ID:
NCT07341893
Status:
RECRUITING
Last Update Posted:
2026-01-14
First Post:
2026-01-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sacubitril-valsartan in Patients With Heart Failure.
Sponsor:
Damanhour University
Organization:
Study Overview
Official Title:
Clinical Study Evaluating Efficacy and Safety Sacubitril-valsartan in Patients With Heart Failure.
Status:
RECRUITING
Status Verified Date:
2026-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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:
1. MACE such as MI, stroke, HF, or death.
2. LV Echocardiography improvements of any of basic Echo parameters.
3. 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.
* 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:
1. MACE such as MI, stroke, HF, or death.
2. LV Echocardiography improvements of any of basic Echo parameters.
3. 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: