Trial · NCT02468232
Registered outcomes27
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 27
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Who Had CEC (Clinical Endpoint Committee) Confirmed Composite Endpoints | up to 40 months | Composite endpoint is defined as either cardiovascular (CV) death or heart failure (HF) hospitalization in Japanese patients with chronic heart failure (CHF) and reduced ejection fraction. The composite endpoint events occurred on and after End-of-study (EOS) declaration were reported by investigators but those events were not required to be adjudicated by Clinical Endpoint Committee (CEC) and not included in the efficacy analysis. |
| Primary | Exposure-adjusted Incident Rate (EAIR) of CEC Confirmed Composite Endpoints | up to 40 months | Composite endpoint is defined as either cardiovascular (CV) death or heart failure (HF) hospitalization in Japanese patients with chronic heart failure (CHF) and reduced ejection fraction. EAIR = n/T where n = Total number of events included in the analysis. T (100 patient years) = total up-to-event/censoring duration-time summarized over participants in the respective treatment group. The composite endpoint events occurred on and after EOS declaration were reported by investigators but those events were not required to be adjudicated by CEC and not included in the efficacy analysis. |
| Secondary | Key Secondary: Change From Baseline to the Pre-defined Time-points in Log-transformed Concentration of N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) | Baseline, Weeks 4, 8 and Month 6 | NT-proBNP is small protein produced in large amounts when the heart senses it needs to work harder, such as in heart failure. Change from baseline to the pre-defined time-points in logarithmic scale were analyzed using a repeated measures ANCOVA model with treatment, the stratification factor screening NT-proBNP classification recorded in the Interactive Web Response System (IWRS), visit and treatment-by-visit interaction as fixed effect factors and the logarithmic baseline biomarker value as a covariate, with a common unstructured covariance matrix among visits for each treatment. The analysis is using all available data up to month 6 based on likelihood method with an assumption of missing at random (MAR) for missing data. This record summarizes the estimates of ratio Post-baseline /Baseline NT-proBNP. |
| Secondary | Key Secondary: Number of Participants With CEC-confirmed First Triple Composite Endpoint (Cardiovascular (CV) Death, Heart Failure (HF) Hospitalization, or Worsening of HF in Outpatients) | up to 40 months | Composite endpoint is defined as either cardiovascular (CV) death or heart failure (HF) hospitalization in Japanese patients with chronic heart failure (CHF) and reduced ejection fraction. Worsening HF defined as: worsening signs and symptoms of HF requiring addition of a new drug for HF treatment, initiation of IV treatment, increase of diuretic dose for persistent use for ≥4 consecutive weeks, or institution of mechanical or circulatory support such as mechanical ventilation, ultrafiltration, hemodialysis, intra-aortic balloon pump or ventricular assist device. The composite endpoint events occurred on and after EOS declaration were reported by investigators but those events were not required to be adjudicated by CEC and not included in the efficacy analysis. |
| Secondary | Key Secondary: EAIR of CEC-confirmed First Triple Composite Endpoint (Cardiovascular (CV) Death, Heart Failure (HF) Hospitalization, or Worsening of HF in Outpatients) | up to 40 months | Worsening HF defined as: worsening signs and symptoms of HF requiring addition of a new drug for HF treatment, initiation of IV treatment, increase of diuretic dose for persistent use for ≥4 consecutive weeks, or institution of mechanical or circulatory support such as mechanical ventilation, ultrafiltration, hemodialysis, intra-aortic balloon pump or ventricular assist device. EAIR(Exposure-adjusted incidence rate per 100 patient years)= n/T: n: Total number of events included in the analysis. T(100 patient years): total up-to-event/censoring duration-time summarized over patients in the respective treatment group. The composite endpoint events occurred on and after EOS declaration were reported by investigators but those events were not required to be adjudicated by CEC and not included in the efficacy analysis. |
| Secondary | Key Secondary: Number of Participants by Changes in New York Heart Association (NYHA) Classification From Baseline at Predefined Timepoints | Baseline, Weeks 4, 8 and Month 6 | NYHA classification is a subjective physician's assessment of heart failure patient's functional capacity and symptomatic status. Class I - No limitation of physical activity. Class II - Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath). Class III - Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea. Class IV - Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases. The NYHA class change was 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. NYHA class after patients who died was categorized into "worsened". |
| Secondary | Key Secondary: Change From Baseline in Clinical Summary Score for Heart Failure Symptoms and Physical Limitations Assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ). | Baseline, Week 8 and Month 6 | The KCCQ is a self-administered questionnaire and requires, on average, 4-6 minutes to complete. It contains 23 items, covering physical function, clinical symptoms, social function, self-efficacy and knowledge, and Quality of Life (QoL), each with different Likert scaling wording, including limitations, frequency, bother, change in condition, understanding, etc. The clinical summary score is a mean of the physical limitation and total symptom scores. The total symptom score is the mean of the symptom frequency and symptom burden scores. Each scale score (the physical limitation, symptom frequency or symptom burden) is calculated as the mean of its item scores and transformed to a 0-100 scale, with higher score indicating higher level of functioning. A score of 100 represents perfect health whereas a score of 0 represents dead. A change of 5 points on the scale scores, either as a group mean difference or an intra-individual change appears to be clinically significant. |
| Secondary | Total Number of CEC Confirmed Composite of CV Death and Total (First and Recurrent) HF Hospitalizations for Heart Failure | up tp 40 months | Total number of CEC-confirmed CV death and total (first and recurrent) HF hospitalizations per patient was analyzed using the negative binomial regression model. CV deaths and HF hospitalizations occurred on and after EOS declaration were reported by investigators but those events were not required to be adjudicated by CEC and not included in the efficacy analysis. |
| Secondary | Number of Participants by Changes in Clinical Composite Score (as Assessed by NYHA Classification and Patient Global Assessment) at Predefined Timepoints | Baseline, Month 6 | The global assessment was derived from the 7-category classification of the global assessment of disease activity to a three-category classification: Improved (Markedly improved; moderately improved), Unchanged (Slightly improved, unchanged, slightly worsened), and Worsened (Moderately worsened, markedly worsened). The clinical composite assessment was defined as follows: * Improved: 1) If NYHA class decreased at least one level and Global Assessment was not worse at the selected visit and there was no major AE up to the selected visit; or 2) Global assessment was improved and NYHA class did not increase at the selected visit, and there was no major AE up to the selected visit. * Worsened: 1) If NYHA class increased at the selected visit; or 2) Global Assessment was worse at the selected visit; or 3) experienced a major AE up to the selected visit. * Unchanged: If neither "Improved" nor "Worsened". |
| Secondary | Number of Participants With All-cause Mortality | up to 40 months | The number of participants who died due to any cause. Deaths occurred on and after EOS declaration were reported by investigators but those events were not required to be adjudicated by CEC and not included in the efficacy analysis. |
| Secondary | EAIR of All-cause Mortality | up to 40 months | EAIR (Exposure-adjusted incidence rate per 100 patient years)= n/T: n: Total number of events included in the analysis. T(100 patient years): total up-to-event/censoring duration-time summarized over patients in the respective treatment group. Deaths occurred on and after EOS declaration were reported by investigators but those events were not required to be adjudicated by CEC and not included in the efficacy analysis. |
| Secondary | Percentage of Participants Hospitalized | up to 40 months | Percentage of participants with hospitalized admissions |
| Secondary | Hospitalization Admissions Events Per-participant Per Year | up to 40 months | The number of hospital admission events per-participant per year was calculated as total number of hospital admission divided by total up-to-event/censoring duration-time summarized over patients. |
| Secondary | Days in Intensive Care Unit (ICU) Per Participant Per Year | up to 40 months | The number of days in ICU per participant per year was calculated as total number of days in ICU divided by total up-to-event/censoring duration-time summarized over patients. |
| Secondary | Percentage of Re-hospitalizations | up to 40 months | The percentage of participants who had re-hospitalizations. |
| Secondary | Emergency Department/Urgent Care Facility Visits for HF Per Patient Per Year | up to 40 months | The number of emergency department/urgent care facility visits for HF per patient per year was calculated as total number of emergency department/urgent care facility visits for HF divided by total up-to-event/censoring duration-time summarized over patients. |
| Secondary | Change in Blood NT-proBNP From Baseline | Baseline, Weeks 2, 4, 8 and Month 6 | NT-proBNP is small protein produced in large amounts when the heart senses it needs to work harder, such as in heart failure. Mean change from baseline (post-baseline value - baseline value) in plasma NT-proBNP was caluculated. |
| Secondary | Change in Procollagen Type III N-Terminal Propeptide From Baseline | Baseline and Month 18 | Procollagen Type III N-Terminal Propeptide (PIIINP) is a serum marker of collagen turnover, generated during the synthesis of type III collagen. Increased circulating PIIINP is a marker not only of muscle growth, but also of muscle repair and fibrosis. Mean change from baseline (post-baseline value - baseline value) in serum PIIINP was calculated. |
| Secondary | Changes in Urine Cyclic Guanosine 3',5'-Monophosphate (cGMP) From Baseline | Baseline, Weeks 4, 8 and Month 6 | Urinary Cyclic GMP (cGMP) is a biomarker measured in the urine that reflects the activity of biomarkers such as BNP (Brain Natriuretic Peptide). First morning void (FMV) urine samples were collected. Mean change from baseline (post-baseline value - baseline value) in urine cGMP was calculated. |
| Secondary | Percentage of Participants Reaching Target Dose Level 3 at Week 8 and Maintained at Month 4 (Open Label Extension (OLE)) | Month 4 of OLE | The percentage of participants who reached target dose level (200 mg b.i.d.) at Week 8 and maintained at Month 4(OLE). This indicates how tolerabile to LCZ696 at target dose. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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