Trial · NCT01920711
Efficacy and Safety of LCZ696 Compared to Valsartan, on Morbidity and Mortality in Heart Failure Patients With Preserved Ejection Fraction
NCT01920711, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2020-09-29
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety of LCZ696 Compared to Valsartan, on Morbidity and Mortality in Heart Failure Patients With Preserved Ejection Fraction. Trials, record NCT01920711. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01920711
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of LCZ696 Compared to Valsartan, on Morbidity and Mortality in Heart Failure Patients With Preserved Ejection Fraction
- NCT number
- NCT01920711
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 4,822 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Heart Failure With Preserved Ejection Fraction
- Interventions
- LCZ696, Valsartan
- First posted
- 2013-08-12
- Last updated
- 2020-09-29
- Other registries' IDs
- eudract:2013-001747-31
- Results first posted
- 2020-09-29
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Cumulative Number of Primary Composite Events of Cardiovascular (CV) Death and Total (First and Recurrent) HF Hospitalizations. | Total follow up time (up to 57 months) | The primary objective of this study is to compare LCZ696 to valsartan in reducing the rate of the composite endpoint of CV death and total (first and recurrent) HF hospitalizations, in HF patients (New York Heart Association \[NYHA\] Class II-IV) with preserved ejection fraction (left ventricular ejection fraction \[LVEF\] ≥45%). The treatment arm with the lower rate of events will be deemed as having a successful response. |
| Secondary | Change in the Clinical Summary Score From Baseline to Month 8 by Kansas City Cardiomyopathy Questionnaire (KCCQ) | Baseline, 8 months | The KCCQ is a validated instrument for self-assessment of quality of life and health status in heart failure (HF) patients. The clinical summary score, which is derived from the physical limitations and heart failure (HF) symptoms domains of the KCCQ is a valid measure for assessing the patient's health aspects that may be influenced by CV medications. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. Evaluation of change from baseline to month 8 in KCCQ a most sensitive, specific, and responsive health-related quality of life measure for heart failure symptoms and physical limitations. |
| Secondary | Change From Baseline to Month 8 in New York Heart Association (NYHA) Functional Class | Baseline, 8 months | Evaluation of change from baseline to Month 8 in NYHA functional class, a well established grading scale used to classify a heart failure's (HF) patients' level of functionality based on the signs and symptoms of HF exhibited by the patient. |
| Secondary | Participants With First Occurrence of a Composite Renal Endpoint | Randomization to total follow-up time (up to 57 months) | Analyis of composite renal endpoint defined as renal death, or reaching ESRD, or ≥50% decline in eGFR relative to baseline, using Cox's proportional hazards model. |
| Secondary | All-cause Mortality | Randomization to total follow up time (up to 57 months) | Analysis for all-cause mortality using Cox's proportional hazards model. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Cumulative Number of Primary Composite Events of Cardiovascular (CV) Death and Total (First and Recurrent) HF Hospitalizations. | Total follow up time (up to 57 months) | Full Analysis Set - This was the primary efficacy population applied in efficacy analyses for all efficacy endpoints. | Events | NUMBER |
| SECONDARY | Change in the Clinical Summary Score From Baseline to Month 8 by Kansas City Cardiomyopathy Questionnaire (KCCQ) | Baseline, 8 months | Full Analysis Set-This was the primary efficacy population applied in efficacy analyses for all efficacy endpoints. | Points on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Month 8 in New York Heart Association (NYHA) Functional Class | Baseline, 8 months | Full Analysis Set - This was the primary efficacy population applied in efficacy analyses for all efficacy endpoints. However, this endpoint only includes those participants who had assessments completed for both Baseline and Month 8 visits; as that is the only way a change could be calculated and analyzed. | Number of Participants | NUMBER |
| SECONDARY | Participants With First Occurrence of a Composite Renal Endpoint | Randomization to total follow-up time (up to 57 months) | Full Analysis Set -This was the primary efficacy population applied in efficacy analyses for all efficacy endpoints. | Participants | NUMBER |
| SECONDARY | All-cause Mortality | Randomization to total follow up time (up to 57 months) | Full Analysis Set -This was the primary efficacy population applied in efficacy analyses for all efficacy endpoints. | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Cumulative Number of Primary Composite Events of Cardiovascular (CV) Death and Total (First and Recurrent) HF Hospitalizations. | LCZ696 | Primary Composite Events | 894 | Events | |
| Cumulative Number of Primary Composite Events of Cardiovascular (CV) Death and Total (First and Recurrent) HF Hospitalizations. | Valsartan | Primary Composite Events | 1009 | Events | |
| Cumulative Number of Primary Composite Events of Cardiovascular (CV) Death and Total (First and Recurrent) HF Hospitalizations. | LCZ696 | Total Hospitalizations for heart failure | 690 | Events | |
| Cumulative Number of Primary Composite Events of Cardiovascular (CV) Death and Total (First and Recurrent) HF Hospitalizations. | Valsartan | Total Hospitalizations for heart failure | 797 | Events | |
| Cumulative Number of Primary Composite Events of Cardiovascular (CV) Death and Total (First and Recurrent) HF Hospitalizations. | LCZ696 | Cardiovascular death | 204 | Events | |
| Cumulative Number of Primary Composite Events of Cardiovascular (CV) Death and Total (First and Recurrent) HF Hospitalizations. | Valsartan | Cardiovascular death | 212 | Events | |
| Change in the Clinical Summary Score From Baseline to Month 8 by Kansas City Cardiomyopathy Questionnaire (KCCQ) | LCZ696 | -1.5073 | Standard Error 0.3709 | Points on a scale | |
| Change in the Clinical Summary Score From Baseline to Month 8 by Kansas City Cardiomyopathy Questionnaire (KCCQ) | Valsartan | -2.5338 | Standard Error 0.3729 | Points on a scale | |
| Change From Baseline to Month 8 in New York Heart Association (NYHA) Functional Class | LCZ696 | Improved (n=2316, 2302) | 347 | Number of Participants | |
| Change From Baseline to Month 8 in New York Heart Association (NYHA) Functional Class | Valsartan | Improved (n=2316, 2302) | 289 | Number of Participants |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | LCZ696 | 2,419 | |
| Overall Study | STARTED | Valsartan | 2,403 | |
| Overall Study | COMPLETED | LCZ696 | 2,055 | |
| Overall Study | COMPLETED | Valsartan | 2,030 | |
| Overall Study | NOT COMPLETED | LCZ696 | 364 | |
| Overall Study | NOT COMPLETED | Valsartan | 373 |
Source ClinicalTrials.gov
Adverse events3,999
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 | Anaemia | Blood and lymphatic system disorders | LCZ696 | 166 | 2,419 | |
| other | Anaemia | Blood and lymphatic system disorders | Valsartan | 214 | 2,402 | |
| other | Anaemia | Blood and lymphatic system disorders | All Patients | 380 | 4,821 | |
| other | Angina pectoris | Cardiac disorders | LCZ696 | 87 | 2,419 | |
| other | Angina pectoris | Cardiac disorders | Valsartan | 82 | 2,402 | |
| other | Angina pectoris | Cardiac disorders | All Patients | 169 | 4,821 | |
| other | Atrial fibrillation | Cardiac disorders | LCZ696 | 248 | 2,419 | |
| other | Atrial fibrillation | Cardiac disorders | Valsartan | 239 | 2,402 | |
| other | Atrial fibrillation | Cardiac disorders | All Patients | 487 | 4,821 | |
| other | Bradycardia | Cardiac disorders | LCZ696 | 53 | 2,419 |
1 to 10 of 3,999Source ClinicalTrials.gov
See all 3,999 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | LCZ696 | 347 | 2,419 |
| Total, all-cause mortality | Valsartan | 357 | 2,402 |
| Total, all-cause mortality | All Patients | 704 | 4,821 |
| Total, other adverse events | LCZ696 | 2,005 | 2,419 |
| Total, other adverse events | Valsartan | 1,995 | 2,402 |
| Total, other adverse events | All Patients | 4,000 | 4,821 |
| Total, serious adverse events | LCZ696 | 1,424 | 2,419 |
| Total, serious adverse events | Valsartan | 1,416 | 2,402 |
| Total, serious adverse events | All Patients | 2,840 | 4,821 |
Source ClinicalTrials.gov
Papers56
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| LCZ696 vs Valsartan: All-cause Mortality |
Source 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/NCT01920711
GET https://conductscience.org/api/trials/v1/NCT01920711/results?page=2