Outcomes25

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

1 to 20 of 25

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Composite Outcome of Cardiovascular Mortality, Aborted Cardiac Arrest, or Hospitalization for the Management of Heart Failure, Whichever Occurred First	Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.	All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.	Events per 100 person-years	NUMBER
SECONDARY	Cardiovascular Mortality	Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.	All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.	Events per 100 person-years	NUMBER
SECONDARY	Aborted Cardiac Arrest	Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.	All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.	Events per 100 person-years	NUMBER
SECONDARY	Hospitalization for the Management of Heart Failure	Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.	All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.	Events per 100 person-years	NUMBER
SECONDARY	All-cause Mortality	Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.	All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.	Events per 100 person-years	NUMBER
SECONDARY	Composite Outcome of Cardiovascular Mortality or Cardiovascular-related Hospitalization (i.e., Hospitalization for Myocardial Infarction(MI), Stroke, or the Management of Heart Failure), Whichever Occurred First	Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.	All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.	Events per 100 person-years	NUMBER
SECONDARY	Cardiovascular-related Hospitalization	Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.	All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.	Events per 100 person-years	NUMBER
SECONDARY	Total Hospitalizations (Including Repeat Hospitalizations) for the Management of Heart Failure	Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.	All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.	Events per 100 person-years	NUMBER
SECONDARY	Composite Outcome of Sudden Death or Aborted Cardiac Arrest, Whichever Occurred First	Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.	All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.	Events per 100 person-years	NUMBER
SECONDARY	New Onset Diabetes Mellitus, Among Subjects Without a History of Diabetes Mellitus at Baseline.	Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.	All Participants who were randomized and did not have a history of diabetes mellitus at baseline were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.	Events per 100 person-years	NUMBER
SECONDARY	Development of Atrial Fibrillation, Among Subjects Without a History of Atrial Fibrillation at Baseline.	Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.	All Participants who were randomized and did not have a history of atrial fibrillation at baseline were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.	Events per 100 person-years	NUMBER
SECONDARY	Myocardial Infarction	Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.	All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.	Events per 100 person-years	NUMBER
SECONDARY	Stroke	Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.	All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.	Events per 100 person-years	NUMBER
SECONDARY	Deterioration of Renal Function	Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.	All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.	Events per 100 person-years	NUMBER
SECONDARY	Composite Outcome of Sudden Death, Aborted Cardiac Arrest, or Hospitalization for the Management of Ventricular Tachycardia, Whichever Occurred First	Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.	All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.	Events per 100 person-years	NUMBER
SECONDARY	Quality of Life, as Measured by the Kansas City Cardiomyopathy Questionnaire.	Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.	All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Quality of Life, as Measured by the EuroQOL Visual Analog Scale.	Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.	All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Quality of Life, as Measured by McMaster Overall Treatment Evaluation Questionnaire.	Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.	All Participants from United States, Canada and Argentina who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Depression Symptoms, as Measured by Patient Health Questionnaire.	Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.	All Participants from the United States and Canada who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Hospitalization for Any Reason	Randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.	All Participants who were randomized were included in the analysis. The analysis was Intention to Treat, meaning all participants were analyzed based on their initial treatment assignment and not on the treatment eventually received.	Events per 100 person-years	NUMBER

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

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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Outcomes25

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