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Trial · NCT03718273

Registered outcomes16

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

ListOutcomeTime frameDescription
PrimaryHeart rate reduction.3 monthsReduction of the mean daytime heart rate registered in Holter- electrocardiogram (ECG) after treatment with Ivabradine or Digoxin.
PrimarySerious adverse events3 months
Proportion of patients experiencing syncope, severe bradycardia or any serious adverse reaction requiring hospitalization, emergency visit or death of the patient during treatment with Ivabradine or Digoxin.
SecondaryReduction in the scale of atrial fibrillation (AF) symptoms according to the European Hearth Rhythm Association (EHRA) Score modified.Months 1 and 3.Percentage of patients who experience a reduction in the scale of atrial fibrillation. symptoms according to the EHRA Score modified.
Secondary6 minute walk test (6MWT).Baseline and after 3 months.Increase in meters in the 6MWT.
SecondaryQuality-of-Life Short Form 36 (SF-36) Health Survey (QoL SF-36) Score.At baseline and 3 months.Increase in the score obtained in global quality of life parameters analyzed by the SF-36 questionnaire.
SecondaryThe Atrial Fibrillation Effect on Quality-of-Life (QoL AFEQT) score.At baseline and 3 monthsIncrease in the score obtained in parameters of quality of life quality of life associated with AF analyzed by the AFEQT questionnaire.
SecondaryReduction of the daytime Health rate.1 monthReduction of the average daytime Heart Rate (HR) recorded in Holter-ECG
SecondaryReduction of resting Health Rate.1 and 3 monthsReduction of resting heart rate (HR) recorded on one electrocardiogram (ECG).
SecondaryReduction of the maximum heart rate (HR) recorded.1 and 3 monthsReduction of the maximum HR recorded in Holter-ECG
SecondaryReduction of the mean HR recorded.1 and 3 monthsReduction of the mean HR in 24 hours recorded in Holter-ECG .
SecondaryReduction of the HR delta.1 and 3 monthsReduction of the HR delta (difference between maximum HR and mean HR in 24 hours) recorded in Holter-ECG.
SecondaryReduction of HR in moderate exercise.3 monthsReduction of HR in moderate exercise (maximum HR measured by Holter-ECG during the 6-minute walk test.
SecondaryPercentage of patients with non-severe bradycardia.1 and 3 monthsPercentage of patients who experience non-severe bradycardia during the study treatment.
SecondaryPercentage of patients who experience any adverse reaction.1 and 3 monthsPercentage of patients who experience any adverse reaction to the study drugs.
SecondaryPercentage of patients who voluntarily abandon the study drugs.3 monthsPercentage of patients who voluntarily abandon the study drugs.
SecondaryProportion of hospitalizations, emergency visits and mortality due to a major cardiovascular event.3 monthsProportion of patients experiencing hospitalizations, emergency visits and mortality due to a major cardiovascular event during treatment with the study drug.

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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