Heart Failure
Conditions
Keywords
LVEF%,, Lipo A,, troponin I,, NT-Pro BNP,, neopterin
Brief summary
The objective of this study was to identify potential prognostic factors of sacubitril/valsartan vs Valsartan treatment response.
Detailed description
Study will include 80 symptomatic patients with chronic HFrEF (left ventricular ejection fraction ≤35%) and New York Heart Association (NYHA) class II/III: Group 1 (N = 40) received sacubitril/valsartan (target dose, 100 mg twice daily) or group 2 received valsartan (target dose, 80 mg twice daily) in addition to recommended therapy according to physician's judgment. Analysis of biochemical parameters, cardiopulmonary exercise testing, and echocardiographic evaluation was performed at baseline and 6 months later. The primary outcome was the change in LVEF%, Lipo A, troponin I, NT-Pro BNP and neopterin levels. The secondary outcome is reporting efficacy and safety of sacubitril/valsartan vs Valsartan use and the relationship between NYHA and EF and biomarkers.
Interventions
Group 1 (N = 40) received sacubitril/valsartan (target dose, 100 mg twice daily) in addition to recommended therapy according to physician's judgment.
DRUGValsartan 80 mg
group 2 received valsartan (N=40, target dose, 80 mg twice daily) in addition to recommended therapy according to physician's judgment.
Sponsors
Tanta University
Damanhour University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Double Blind randomized controlled trial
Intervention model description
Group 1 (N = 40) received sacubitril/valsartan (target dose, 100 mg twice daily) or group 2 received valsartan (target dose, 80 mg twice daily) in addition to recommended therapy according to physician's judgment.
Eligibility
Sex/Gender
ALL
Age
35 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients with HF were enrolled if aged \> 35 years, * Stable symptomatic systolic chronic HF (≥ 4 weeks), with left ventricular ejection fraction (LVEF) \< 35%, * NYHA class II-III, * Sinus rhythm and resting HR ≥ 70 beats/min on optimised standard medical therapy.
Exclusion criteria
* Patients with acute decompensation, * Cerebrovascular events during the previous 6 months, * Pregnancy, breastfeeding, * Any valve dysfunction/abnormality, * Active myocarditis, * Second-degree and third-degree atrioventricular block, * Sick sinus syndrome.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| LVEF % | 6 months | left ventricular ejection fraction percent |
| Lipo A (pg/ml) | 6 months | Lipo protien A (pg/ml) |
| Troponin.I (ng/ml) | 6 months | Troponin.I (ng/ml) biomarker |
| NT-Pro BNP | 6 months | NT-pro BNP(pg/ml) biomarker |
| Neopterin (nmol/l) | 6 Months | Neopterin biomarker |
Countries
Egypt
Outcome results
None listed