Phase 4
Completed N=40
Demonstration of Reverse Remodeling Effects of Entresto. Using Echocardiography Endocardial Surface Analysis
Source: ClinicalTrials.gov NCT02754518 ↗Enrolled (actual)
40
Serious AEs
10.0%
Results posted
Jan 2021
Primary outcomePrimary: Change From Baseline in LV Remodeling 2D End-Diastolic Diameter (cm) — 6; 6 cm — p=<0.001
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This study intends to measure the effects of valsartan/sacubitril compared to baseline standard medical heart failure therapy on reverse remodeling using echocardiographic endocardial surface analysis techniques to assess changes in ventricular volume, function, and shape.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in LV Remodeling 2D End-Diastolic Diameter (cm) |
6; 6 | <0.001 sig |
| PRIMARY Change From Baseline in LV Remodeling 2D End-Systolic Diameter (cm) |
5.3; 4.5 | <0.001 sig |
| PRIMARY Change From Baseline in LV Remodeling Global Longitudinal Strain (%) |
-12.9; -15.3 | <0.001 sig |
| PRIMARY Change From Baseline in LV Remodeling Left Atrial Volume (mL) |
90.9; 65.6 | <0.001 sig |
| PRIMARY Change From Baseline in LV Remodeling 3D End-Diastolic Volume (mL) |
243.5; 160.2 | <0.001 sig |
| PRIMARY Change From Baseline in LV Remodeling 3D End-Systolic Volume (mL) |
159.7; 90.7 | <0.001 sig |
| PRIMARY Change From Baseline in LV Remodeling LV Ejection Fraction (%) |
32; 43 | <0.001 sig |
| PRIMARY Change From Baseline in LV Remodeling Conicity (%) |
0.75; 0.77 | 0.13 |
| PRIMARY Change From Baseline in LV Remodeling Sphericity (%) |
0.73; 0.71 | 0.95 |
| PRIMARY Change From Baseline in RV Remodeling End-Diastolic Volume (mL) |
143; 104 | <0.001 sig |
| PRIMARY Change From Baseline in RV Remodeling End Systolic Volume (mL) |
73; 47 | <0.001 sig |
| PRIMARY Change From Baseline in RV Remodeling Ejection Fraction (%) |
50; 50 | 0.65 |
| PRIMARY Change From Baseline in RV Remodeling Septal Curvature (%) |
0.86; 0.77 | 0.06 |
| PRIMARY Change From Baseline in RV Remodeling Free-Wall Curvature (%) |
1.17; 1.14 | 0.76 |
| PRIMARY Change From Baseline in RV Remodeling Tricuspid Regurgitation |
3; 30; 4; 2; 0; 1 | 0.07 |
| SECONDARY Change From Baseline in Rho-associated Protein Kinase (ROCK) |
1.1; 0.7 | 0.001 sig |
| SECONDARY Change From Baseline in (MIBG) Early hm Ratio |
1.54 | — |
| SECONDARY Change From Baseline in (MIBG) Late hm Ratio |
1.43 | — |
| SECONDARY Change From Baseline in NT-proBNP Levels |
333; 290 | 0.03 sig |
| SECONDARY Change From Baseline in Exercise Performance - 6 Minute Walk |
425; 486 | <0.001 sig |
| SECONDARY Change From Baseline in Exercise Performance - CPX - Peak VO2 (mL/kg/Min) |
17.5; 19.5 | 0.02 sig |
| SECONDARY Change From Baseline in Exercise Performance - CPX - Peak RER |
1.14; 1.06 | <0.001 sig |
| SECONDARY Change From Baseline in Exercise Performance - CPX - VE/VC02 |
33; 33 | 0.82 |
| SECONDARY Change From Baseline in Blood Pressure - Systolic (mmHg) |
131; 114 | <0.001 sig |
| SECONDARY Change From Baseline in Blood Pressure - Diastolic (mmHg) |
82; 76 | 0.01 sig |
| SECONDARY Change From Baseline in KCCQ - Physical Limitation |
90; 96 | 0.11 |
| SECONDARY Change From Baseline in KCCQ - Symptom Stability |
50; 50 | 0.17 |
| SECONDARY Change From Baseline in KCCQ - Symptom Frequency |
89; 92 | 0.035 sig |
| SECONDARY Change From Baseline in KCCQ - Symptom Burden |
92; 92 | 0.059 |
| SECONDARY Change From Baseline in KCCQ - Total Symptom |
89; 92 | 0.054 |
| SECONDARY Change From Baseline in KCCQ - Self Efficacy |
88; 100 | 0.28 |
| SECONDARY Change From Baseline in KCCQ - Quality of Life Score |
67; 83 | 0.002 sig |
| SECONDARY Change From Baseline in KCCQ - Social Limitation |
81; 94 | 0.008 sig |
| SECONDARY Change From Baseline in KCCQ - Overall Summary |
82; 90 | 0.005 sig |
| SECONDARY Change From Baseline in KCCQ - Clinical Summary |
91; 94.5 | 0.056 |
Eligibility Criteria
Inclusion Criteria
- Males and females aged ≥18 years
- Congestive Heart Failure (CHF) New York Heart Association (NYHA) class II-IV with 25%≤ Left Ventricular Ejection Fraction (LVEF) ≤40% (ECHO within last 6 months)
- NT-proBNP ≥ 600 pg/mL OR
- NT-proBNP ≥ 400 pg/mL and a hospitalization for heart failure within the last 12 months
- Stable and optimized on an angiotensin-converting-enzyme inhibitor (ACEI) equivalent to enalapril ≥ 10 twice a day (BID) for at least 4 weeks
- Stable and optimized on a beta-blocker for at least 4 weeks
- Optimized dosing of aldosterone antagonist at stable dose for at least 4 weeks
Exclusion Criteria
- History of angioedema
- estimated glomerular filtration rate (eGFR) 5.2 mmol/L at screening
- Symptomatic hypotension as defined by Investigator, systolic blood pressure (SBP) < 100 mmHg at screening
- Current acute decompensated heart failure
- History of severe pulmonary disease
- Active malignancy
- Requirement for treatment with both angiotensin-converting-enzyme inhibitor (ACEI) and angiotensin receptor blockers (ARB)
Data sourced from ClinicalTrials.gov (NCT02754518). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.