Trial · NCT02554890
Comparison of Sacubitril/Valsartan Versus Enalapril on Effect on NT-proBNP in Patients Stabilized From an Acute Heart Failure Episode.
NCT02554890, Phase 4, Completed, Novartis Pharmaceuticals; results first posted 2019-09-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Comparison of Sacubitril/Valsartan Versus Enalapril on Effect on NT-proBNP in Patients Stabilized From an Acute Heart Failure Episode. Trials, record NCT02554890. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02554890
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comparison of Sacubitril/Valsartan Versus Enalapril on Effect on NT-proBNP in Patients Stabilized From an Acute Heart Failure Episode.
- NCT number
- NCT02554890
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 887 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Acute Heart Failure
- Interventions
- sacubitril/valsartan (LCZ696), Enalapril, sacubitril/valsartan (LCZ696) matching placebo, enalapril matching placebo
- First posted
- 2015-09-18
- Last updated
- 2021-01-05
- Results first posted
- 2019-09-24
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) Values and Time-averaged Change From Baseline | Baseline, Week 4 and Week 8 | To assess the effect of in-hospital initiation of sacubitril/valsartan vs. enalapril on the time-averaged percentage change of NT-proBNP from baseline in patients who have been stabilized following hospitalization for ADHF and reduced ejection fraction (left ventricular ejection fraction \[LVEF\] ≤ 40%) between week 4 and 8. Number of patients with both a baseline value and a value at Week 4 or Week 8. Plasma NT-proBNP (pg/mL) values were averaged from Week 4 and Week 8 visits. N-terminal pro b-type natriuretic peptide (NTproBNP) are peptide (small proteins) that are either hormones or part of the peptide that contained the hormone at one time. They are continually produced in small quantities in the heart and released in larger quantities when the heart senses that it needs to work harder, as in heart failure. |
| Secondary | Number of Patients With Incidences of Symptomatic Hypotension | 8 weeks of treatment | Examine the effect of LCZ696 vs. enalapril on incidence of symptomatic hypotension during 8 weeks of treatment Hypotension is low blood pressure. Patients with hypotension may experience symptoms when their blood pressure drops, compared to the patient's normal values. Symptoms of hypotension can include dizziness, lightheadedness, blurred vision, weakness, fatigue, nausea, palpitations, and headache. |
| Secondary | Number of Patients With Incidences of Hyperkalemia | 8 weeks of treatment | Hyperkalemia is defined as Potassium level \>5.5 mEq/L. Hyperkalemia is the medical term that describes a potassium level in your blood that's higher than normal. Potassium is a chemical that is critical to the function of nerve and muscle cells, including those in your heart. |
| Secondary | Number of Patients With Incidences of Angioedema | 8 weeks of treatment | Angioedema is a type of abrupt swelling that occurs under the skin and/or mucous membranes and is often localized to the head, neck, throat, and/or tongue, but may occur elsewhere, including the genitalia and intestines. Severe cases may be associated with difficulty in breathing. |
| Secondary | Change From Baseline in High Sensitivity Troponin (Hs-Troponin) | Baseline, Week 4/Week 8 | time-averaged (Weeks 4 and 8) change from baseline in hs-troponin T. hs-Troponin-T is a biomarker that is released from the heart under stress or injury conditions. |
| Secondary | Change From Baseline in Urinary cGMP | Baseline, Week 4 and Week 8 | Time-averaged (Weeks 4 and 8) change from baseline in urinary cGMP. Urinary Cyclic GMP (cGMP) is a biomarker measured in the urine that reflects the activity of biomarkers such as BNP (Brain Natriuretic Peptide) |
| Secondary | Change From Baseline in Urinary cGMP to Urinary Creatinine Ratio | Baseline, Week 4 and Week 8 | Time-averaged (Weeks 4 and 8) change from baseline in urinary cGMP to urinary creatinine ratio. Urinary cGMP to urinary creatinine ratio is how much urinary cGMP (which reflects natriuretic peptide activity) compared to a compound in the urine called creatinine (which helps your doctor evaluate how well your kidneys are functioning). |
| Secondary | Change From Baseline in BNP to NTproBNP Ratio | baseline, Week 4 and Week 8 | Time-averaged (Weeks 4 and 8) change from baseline in BNP to NT-proBNP ratio. BNP and NT-proBNP are small proteins produced in large amounts when the heart senses it needs to work harder, such as in heart failure. The test measuring BNP to NT-proBNP is measuring how much of each of these biomarkers are present in order to evaluate heart failure. |
| Secondary | N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) Values and Change From Baseline at Week 8 | Baseline, Week 8 | BNP and NT-proBNP are small proteins produced in large amounts when the heart senses it needs to work harder, such as in heart failure. The test measuring BNP to NT-proBNP is measuring how much of each of these biomarkers are present in order to evaluate heart failure. Plasma NT-proBNP (pg/mL) values were Week 8 visit. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) Values and Time-averaged Change From Baseline | Baseline, Week 4 and Week 8 | Full analysis set (FAS): consisted of all randomized patients with the exception for those patients who had not been qualified for randomization and had not received study treatment, but had been inadvertently randomized into the study. | pg/ml | GEOMETRIC_MEAN |
| SECONDARY | Number of Patients With Incidences of Symptomatic Hypotension | 8 weeks of treatment | FAS | participants | NUMBER |
| SECONDARY | Number of Patients With Incidences of Hyperkalemia | 8 weeks of treatment | FAS | Participants | NUMBER |
| SECONDARY | Number of Patients With Incidences of Angioedema | 8 weeks of treatment | FAS | Participants | NUMBER |
| SECONDARY | Change From Baseline in High Sensitivity Troponin (Hs-Troponin) | Baseline, Week 4/Week 8 | FAS | Ratio | GEOMETRIC_MEAN |
| SECONDARY | Change From Baseline in Urinary cGMP | Baseline, Week 4 and Week 8 | FAS | Ratio | GEOMETRIC_MEAN |
| SECONDARY | Change From Baseline in Urinary cGMP to Urinary Creatinine Ratio | Baseline, Week 4 and Week 8 | FAS | Ratio | GEOMETRIC_MEAN |
| SECONDARY | Change From Baseline in BNP to NTproBNP Ratio | baseline, Week 4 and Week 8 | FAS | Ratio | GEOMETRIC_MEAN |
| SECONDARY | N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) Values and Change From Baseline at Week 8 | Baseline, Week 8 | Full analysis set (FAS): consisted of all randomized patients with the exception for those patients who had not been qualified for randomization and had not received study treatment, but had been inadvertently randomized into the study. | pg/ml | GEOMETRIC_MEAN |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) Values and Time-averaged Change From Baseline | Enalapril | 0.7466 | 95% Confidence Interval 0.6842 to 0.8147 | pg/ml | |
| N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) Values and Time-averaged Change From Baseline | Sacubitril/Valsartan (LCZ696) | 0.5333 | 95% Confidence Interval 0.4890 to 0.5816 | pg/ml | |
| Number of Patients With Incidences of Symptomatic Hypotension | Enalapril | 56 | participants | ||
| Number of Patients With Incidences of Symptomatic Hypotension | Sacubitril/Valsartan (LCZ696) | 66 | participants | ||
| Number of Patients With Incidences of Hyperkalemia | Enalapril | 41 | Participants | ||
| Number of Patients With Incidences of Hyperkalemia | Sacubitril/Valsartan (LCZ696) | 51 | Participants | ||
| Number of Patients With Incidences of Angioedema | Enalapril | 11 | Participants | ||
| Number of Patients With Incidences of Angioedema | Sacubitril/Valsartan (LCZ696) | 1 | Participants | ||
| Change From Baseline in High Sensitivity Troponin (Hs-Troponin) | Enalapril | 0.7477 | 95% Confidence Interval 0.6979 to 0.8010 | Ratio | |
| Change From Baseline in High Sensitivity Troponin (Hs-Troponin) | Sacubitril/Valsartan (LCZ696) | 0.6345 | 95% Confidence Interval 0.5920 to 0.6801 | Ratio |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow14
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Double-blind | STARTED | Enalapril | 444 | |
| Double-blind | STARTED | Sacubitril/Valsartan (LCZ696) | 443 | |
| Double-blind | Treated Patients | Enalapril | 436 | |
| Double-blind | Treated Patients | Sacubitril/Valsartan (LCZ696) | 439 | |
| Double-blind | COMPLETED | Enalapril | 348 | |
| Double-blind | COMPLETED | Sacubitril/Valsartan (LCZ696) | 352 | |
| Double-blind | NOT COMPLETED | Enalapril | 96 | |
| Double-blind | NOT COMPLETED | Sacubitril/Valsartan (LCZ696) | 91 | |
| Open-label | STARTED | Enalapril | 0 | |
| Open-label | STARTED | Sacubitril/Valsartan (LCZ696) | 887 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 participant flowAdverse events816
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Blood creatinine increased | Investigations | Double Blind Phase Enalapril | 19 | 436 | |
| other | Blood creatinine increased | Investigations | Double Blind Phase Sacubitril/Valsartan | 30 | 439 | |
| other | Blood creatinine increased | Investigations | Open-Label Phase Sacubitril/Valsartan | 7 | 828 | |
| other | Blood creatinine increased | Investigations | Pooled Phase Sacubitril/Valsartan | 36 | 851 | |
| other | Hyperkalaemia | Metabolism and nutrition disorders | Double Blind Phase Enalapril | 39 | 436 | |
| other | Hyperkalaemia | Metabolism and nutrition disorders | Double Blind Phase Sacubitril/Valsartan | 47 | 439 | |
| other | Hyperkalaemia | Metabolism and nutrition disorders | Open-Label Phase Sacubitril/Valsartan | 11 | 828 | |
| other | Hyperkalaemia | Metabolism and nutrition disorders | Pooled Phase Sacubitril/Valsartan | 57 | 851 | |
| other | Dizziness | Nervous system disorders | Double Blind Phase Enalapril | 33 | 436 | |
| other | Dizziness | Nervous system disorders | Double Blind Phase Sacubitril/Valsartan | 38 | 439 |
1 to 10 of 816Source ClinicalTrials.gov
See all 816 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Double Blind Phase Enalapril | 15 | 436 |
| Total, all-cause mortality | Double Blind Phase Sacubitril/Valsartan | 10 | 439 |
| Total, all-cause mortality | Open-Label Phase Sacubitril/Valsartan | 6 | 828 |
| Total, all-cause mortality | Pooled Phase Sacubitril/Valsartan | 16 | 851 |
| Total, other adverse events | Double Blind Phase Enalapril | 139 | 436 |
| Total, other adverse events | Double Blind Phase Sacubitril/Valsartan | 153 | 439 |
| Total, other adverse events | Open-Label Phase Sacubitril/Valsartan | 65 | 828 |
| Total, other adverse events | Pooled Phase Sacubitril/Valsartan | 199 | 851 |
| Total, serious adverse events | Double Blind Phase Enalapril | 132 | 436 |
| Total, serious adverse events | Double Blind Phase Sacubitril/Valsartan | 117 | 439 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers8
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Enalapril vs Sacubitril/Valsartan (LCZ696): Number of Patients With Incidences of Symptomatic Hypotension | Trial comparisons |
| Enalapril vs Sacubitril/Valsartan (LCZ696): Number of Patients With Incidences of Angioedema | Trial comparisons |
| Enalapril vs Sacubitril/Valsartan (LCZ696): Number of Patients With Incidences of Hyperkalemia | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02554890
GET https://conductscience.org/api/trials/v1/NCT02554890/events?page=2