Trial · NCT03066804
A Randomized, Double-blind Controlled Study Comparing LCZ696 to Medical Therapy for Comorbidities in HFpEF Patients
NCT03066804, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2021-02-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Randomized, Double-blind Controlled Study Comparing LCZ696 to Medical Therapy for Comorbidities in HFpEF Patients. Trials, record NCT03066804. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03066804
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Randomized, Double-blind Controlled Study Comparing LCZ696 to Medical Therapy for Comorbidities in HFpEF Patients
- NCT number
- NCT03066804
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 2,572 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Heart Failure With Preserved Ejection Fraction
- Interventions
- sacubitril/valsartan, Enalapril, Valsartan, Placebo to match sacubitril/valsartan, Placebo to match enalapril, Placebo to match valsartan
- First posted
- 2017-02-28
- Last updated
- 2021-10-11
- Other registries' IDs
- eudract:2016-003410-28
- Results first posted
- 2021-02-08
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) at Week 12 | Baseline, week 12 | To demonstrate that LCZ696 is superior to individualized medical therapy for comorbidities in reducing NT-proBNP from baseline at Week 12 in patients with HFpEF |
| Primary | Change From Baseline in 6 Minute Walk Distance (6MWD) at Week 24 | Baseline, week 24 | Change from baseline in 6-minute walk distance (6MWD) will be reported at Week 24. The 6 MWT will be performed in accordance with the guidelines of the American Thoracic Society 2002. |
| Secondary | Mean Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score (CSS) at Week 24 | Baseline, Week 24 | The KCCQ is a self-administered questionnaire that requires 4 to 6 minutes to complete. It contains 23 items, covering physical function, clinical symptoms, social function, self-efficacy and knowledge, and Quality of Life (QoL). The CSS is a combined score based upon the clinical symptoms and physical function domains of the questionnaire. Scores are transformed to a range of 0 - 100, in which higher scores reflect better health status. |
| Secondary | Percentage of Patients With ≥ 5-points Deterioration in KCCQ Clinical Symptom Score(CSS) at Week 24 | Baseline, Week 24 | Percentage of patients with KCCQ CSS deterioration ≥ 5-points will be reported at Week 24. The KCCQ is a self-administered questionnaire that requires 4 to 6 minutes to complete. It contains 23 items, covering physical function, clinical symptoms, social function, self-efficacy and knowledge, and Quality of Life (QoL). The CSS is a combined score based upon the clinical symptoms and physical function domains of the questionnaire. Scores are transformed to a range of 0 - 100, in which higher scores reflect better health status. |
| Secondary | Percentage of Patients With ≥ 5-points Improvement in KCCQ Clinical Symptom Score(CSS) at Week 24 | Baseline, Week 24 | Percentage of patients with KCCQ CSS improvement ≥ 5-points will be reported at Week 24. The KCCQ is a self-administered questionnaire that requires 4 to 6 minutes to complete. It contains 23 items, covering physical function, clinical symptoms, social function, self-efficacy and knowledge, and Quality of Life (QoL). The CSS is a combined score based upon the clinical symptoms and physical function domains of the questionnaire. Scores are transformed to a range of 0 - 100, in which higher scores reflect better health status. |
| Secondary | Change From Baseline in NYHA Functional Class at Week 24 | Baseline, week 24 | NYHA classification is a subjective physician's assessment of patient's functional capacity and symptomatic status and can change frequently over time. Class I - No limitation of physical activity. Ordinary physical activity does not cause symptoms of HF Class II - Slight limitation of physical activity. Comfortable at rest, but ordinary physical activity results in symptoms of HF Class III - Marked limitation of physical activity. Comfortable at rest, but less than ordinary activity causes symptoms of HF Class IV - Unable to carry on any physical activity without symptoms of HF, or symptoms of HF at rest The NYHA class change will be analyzed as a three category ordinal variable with levels: "improved", "unchanged", and "worsened", defined by at least one class improvement, no change, at least one class worsening, in NYHA class, respectively. |
| Secondary | Change From Baseline in The Short Form 36 Health Survey (SF-36) Physical Component Summary (PCS) Score at Week 24 | Baseline, Week 24 | The SF-36 PCS score reflects the measure of quality of life based on the 36 questions which evaluate the person's physical, emotional, and mental status, including general health. Specifically, the SF-36 PCS score focuses on assessing the person's physical status. The score ranges from 0 to 100 with a higher score indicating a better status of physical wellbeing (range = 0 "worst"-100 "best"). |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) at Week 12 | Baseline, week 12 | Full Analysis Set: This outcome measure represents patients with non-missing change from baseline in log transformed NT-proBNP at Week 12. The model was fitting using change from baseline in log transformed NT-proBNP, and produced a difference in mean change from baseline in log transformed NT-proBNP, which was then transformed back to geometric mean ratio to baseline using an exponential transformation. | Ratio | GEOMETRIC_MEAN |
| PRIMARY | Change From Baseline in 6 Minute Walk Distance (6MWD) at Week 24 | Baseline, week 24 | Subset of Full Analysis Set: This outcome measure was analyzed on patients with a Baseline 6MWD from 100 meters to 450 meters. | Meters | MEAN |
| SECONDARY | Mean Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score (CSS) at Week 24 | Baseline, Week 24 | Full Analysis Set: This outcome measure represents patients with both baseline KCCQ Clinical Symptom Scores (CSS) and Week 24 KCCQ CSS observed and non-missing covariates. | Scores on a scale | MEAN |
| SECONDARY | Percentage of Patients With ≥ 5-points Deterioration in KCCQ Clinical Symptom Score(CSS) at Week 24 | Baseline, Week 24 | Full Analysis Set: This outcome measure represents patients with both baseline KCCQ Clinical Symptom Scores (CSS) and Week 24 KCCQ CSS observed and non-missing covariates. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Patients With ≥ 5-points Improvement in KCCQ Clinical Symptom Score(CSS) at Week 24 | Baseline, Week 24 | Full Analysis Set: This outcome measure represents patients with both baseline KCCQ Clinical Symptom Scores (CSS) and Week 24 KCCQ CSS observed and non-missing covariates. | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in NYHA Functional Class at Week 24 | Baseline, week 24 | Full Analysis Set: This outcome measure represents patients with both a baseline NYHA class and NYHA class at the visit observed. | Percentage of Participants | NUMBER |
| SECONDARY | Change From Baseline in The Short Form 36 Health Survey (SF-36) Physical Component Summary (PCS) Score at Week 24 | Baseline, Week 24 | Full Analysis Set: This outcome measure represents patients with non-missing change from baseline in SF-36 PCS at Week 24. | Scores on a scale | 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 |
|---|---|---|---|---|---|
| Change From Baseline in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) at Week 12 | Sacubitril/Valsartan (LCZ696) | 0.8218 | 95% Confidence Interval 0.7955 to 0.8489 | Ratio | |
| Change From Baseline in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) at Week 12 | Individualized Medical Therapy (IMT) Comparator | 0.9828 | 95% Confidence Interval 0.9515 to 1.0151 | Ratio | |
| Change From Baseline in 6 Minute Walk Distance (6MWD) at Week 24 | Sacubitril/Valsartan (LCZ696) | 9.6935 | 95% Confidence Interval 5.4310 to 13.9559 | Meters | |
| Change From Baseline in 6 Minute Walk Distance (6MWD) at Week 24 | Individualized Medical Therapy (IMT) Comparator | 12.1920 | 95% Confidence Interval 7.9202 to 16.4638 | Meters | |
| Mean Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score (CSS) at Week 24 | Sacubitril/Valsartan (LCZ696) | 12.3399 | 95% Confidence Interval 11.3151 to 13.3647 | Scores on a scale | |
| Mean Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score (CSS) at Week 24 | Individualized Medical Therapy (IMT) Comparator | 11.8168 | 95% Confidence Interval 10.7922 to 12.8415 | Scores on a scale | |
| Percentage of Patients With ≥ 5-points Deterioration in KCCQ Clinical Symptom Score(CSS) at Week 24 | Sacubitril/Valsartan (LCZ696) | 15.49 | Percentage of participants | ||
| Percentage of Patients With ≥ 5-points Deterioration in KCCQ Clinical Symptom Score(CSS) at Week 24 | Individualized Medical Therapy (IMT) Comparator | 16.69 | Percentage of participants | ||
| Percentage of Patients With ≥ 5-points Improvement in KCCQ Clinical Symptom Score(CSS) at Week 24 | Sacubitril/Valsartan (LCZ696) | 67.94 | Percentage of participants | ||
| Percentage of Patients With ≥ 5-points Improvement in KCCQ Clinical Symptom Score(CSS) at Week 24 | Individualized Medical Therapy (IMT) Comparator | 65.70 | Percentage of participants |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sacubitril/Valsartan (LCZ696) | 1,286 | |
| Overall Study | STARTED | Individualized Medical Therapy (IMT) Comparator | 1,286 | |
| Overall Study | COMPLETED | Sacubitril/Valsartan (LCZ696) | 1,235 | |
| Overall Study | COMPLETED | Individualized Medical Therapy (IMT) Comparator | 1,236 | |
| Overall Study | NOT COMPLETED | Sacubitril/Valsartan (LCZ696) | 51 | |
| Overall Study | NOT COMPLETED | Individualized Medical Therapy (IMT) Comparator | 50 |
Source ClinicalTrials.gov
Adverse events840
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 | Sacubitril/Valsartan (LCZ696) | 17 | 1,280 | |
| other | Anaemia | Blood and lymphatic system disorders | Individualized Medical Therapy (IMT) | 28 | 1,284 | |
| other | Anaemia | Blood and lymphatic system disorders | Total | 45 | 2,564 | |
| other | Atrial fibrillation | Cardiac disorders | Sacubitril/Valsartan (LCZ696) | 44 | 1,280 | |
| other | Atrial fibrillation | Cardiac disorders | Individualized Medical Therapy (IMT) | 43 | 1,284 | |
| other | Atrial fibrillation | Cardiac disorders | Total | 87 | 2,564 | |
| other | Cardiac failure | Cardiac disorders | Sacubitril/Valsartan (LCZ696) | 34 | 1,280 | |
| other | Cardiac failure | Cardiac disorders | Individualized Medical Therapy (IMT) | 43 | 1,284 | |
| other | Cardiac failure | Cardiac disorders | Total | 77 | 2,564 | |
| other | Diarrhoea | Gastrointestinal disorders | Sacubitril/Valsartan (LCZ696) | 43 | 1,280 |
1 to 10 of 840Source ClinicalTrials.gov
See all 840 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sacubitril/Valsartan (LCZ696) | 23 | 1,280 |
| Total, all-cause mortality | Individualized Medical Therapy (IMT) | 17 | 1,284 |
| Total, all-cause mortality | Total | 40 | 2,564 |
| Total, other adverse events | Sacubitril/Valsartan (LCZ696) | 964 | 1,280 |
| Total, other adverse events | Individualized Medical Therapy (IMT) | 832 | 1,284 |
| Total, other adverse events | Total | 1,796 | 2,564 |
| Total, serious adverse events | Sacubitril/Valsartan (LCZ696) | 186 | 1,280 |
| Total, serious adverse events | Individualized Medical Therapy (IMT) | 191 | 1,284 |
| Total, serious adverse events | Total | 377 | 2,564 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 34783839 | DERIVED |
Source PubMed
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT03066804
GET https://conductscience.org/api/trials/v1/NCT03066804/events?page=2