Registered outcomes16

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

1 to 16 of 16

List	Outcome	Time frame	Description
Primary	To demonstrate whether low-dose digoxin compared to placebo reduces the rate of the composite CV outcome	Median of 3 years	The composite of total worsening heart failure events (with an event defined as a first or recurrent unplanned hospitalization or urgent visit for heart failure) and death from cardiovascular causes (amount of events)
Secondary	To determine whether low-dose digoxin compared to placebo reduces the rate of the ranked clinical outcomes: composite of all repeated HF hospitalizations and repeated urgent HF visits	Median of 3 years	composite of all repeated HF hospitalizations and repeated urgent HF visits (amount)
Secondary	To determine whether low-dose digoxin compared to placebo reduces the rate of the ranked clinical outcomes: composite of all repeated CV hospitalizations and repeated urgent CV hospital visits	Median of 3 years	composite of all repeated CV hospitalizations and repeated urgent CV hospital visits (amount)
Secondary	To determine whether low-dose digoxin compared to placebo reduces the rate of the ranked clinical outcomes: first-time occurrence of any of the composite of CV-mortality, HF hospitalization or urgent HF hospital visit	Median of 3 years	first-time occurrence of any of the composite of CV-mortality, HF hospitalization or urgent HF hospital visit
Secondary	To determine whether low-dose digoxin compared to placebo reduces the rate of the ranked clinical outcomes: first-time occurrence of any of the composite of all-cause mortality, HF hospitalization or urgent HF hospital visit	Median of 3 years	first-time occurrence of any of the composite of all-cause mortality, HF hospitalization or urgent HF hospital visit
Secondary	To determine whether low-dose digoxin compared to placebo reduces the rate of the ranked clinical outcomes: first-time occurrence of any of the composite of HF hospitalization or urgent HF hospital visit	Median of 3 years	first-time occurrence of any of the composite of HF hospitalization or urgent HF hospital visit
Secondary	To determine whether low-dose digoxin compared to placebo reduces the rate of the ranked clinical outcomes: first time event to CV mortality	Median of 3 years	first time event to CV mortality
Secondary	To determine whether low-dose digoxin compared to placebo reduces the rate of the ranked clinical outcomes: first-time event to all-cause mortality	Median of 3 years	first-time event to all-cause mortality
Other	To determine whether low-dose digoxin compared to placebo improves the exploratory outcomes: all-cause hospitalizations and urgent hospital visits	Median of 3 years	Amount of events per patient years, incidence rate
Other	To determine whether low-dose digoxin compared to placebo improves the exploratory outcomes: days alive and out of hospital	Median of 3 years	amount of days alive and out of hospital
Other	To determine whether low-dose digoxin compared to placebo improves the exploratory outcomes: Quality of Life assessed by the EUROQOL-5D-5L questionnaire	Median of 3 years	Quality of Life is assessed by questions about mobility, selfcare, daily activity, pain and anxiety. The questions about mobility, selfcare and daily activity range from 'no problem doing activity' to 'not able to do activity'. The questions about pain and anxiety range from 'not at all present' to 'extremely present'. The last question in the questionnaire asks how a person rates his or her health in the present day, ranging from 0-100, where 0 is the worst health imaginable, and 100 is the best health imaginable. EQ5DL index value and EQ5DL VAS score (0-100). The EQ-5D-5L is a 2-part instrument, if only one part is used you cannot claim to have used EQ-5D-5L in your publications, therefore this outcome is listed as 1 outcome measure.
Other	To determine whether low-dose digoxin compared to placebo improves the exploratory outcomes: Reported Suspected Unexpected Serious Adverse Reactions (SUSARs)	Median of 3 years	incidence rate (IR) amount of events per patient years
Other	To determine whether low-dose digoxin compared to placebo improves the exploratory outcomes: Heart rate in both AF and sinus rhythm	Median of 3 years	in beats per minute
Other	To determine whether low-dose digoxin compared to placebo improves the exploratory outcomes: Initiation of (and/of recurrence of) AF in patients with sinus rhythm at baseline	Median of 3 years	Amount of events per patient years, incidence rate (IR)
Other	To determine whether low-dose digoxin compared to placebo improves the exploratory outcomes: Conversion to sinus rhythm and maintenance of sinus rhythm in patients with AF at baseline	Median of 3 years	Amount of events per patient years, incidence rate (IR)
Other	To determine whether low-dose digoxin compared to placebo improves the exploratory outcomes: Implantation of pacemaker, ICD, CRT or LVAD	Median of 3 years	Amount of events per patient years, incidence rate (IR)

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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