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Trial · NCT04405804

Registered outcomes15

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

ListOutcomeTime frameDescription
PrimaryHeart rate in b.p.m. (mean (±SD) difference from baseline) at the end of maintenanceAt the end of the two weeks maintenance period (17-29 days from enrollment)To assess the response to ivabradine on heart rate after 14 days of stable therapy
SecondaryHeart rate in b.p.m. (mean (±SD) difference from baseline) at the end of follow-upAt the end of the 16 weeks follow-up period (129-141 days from enrollment)To assess the response to ivabradine on heart rate after 16 weeks of follow-up
SecondarySerum NT-proBNP in pg/mL (mean (±SD) difference from baseline) at the end of maintenanceAt the end of the two weeks maintenance period (17-29 days from enrollment)To assess the response to ivabradine on serum NT-proBNP levels after 14 days of stable therapy
SecondarySerum NT-proBNP in pg/mL (mean (±SD) difference from baseline) at the end of follow-upAt the end of the 16 weeks follow-up period (129-141 days from enrollment)To assess the response to ivabradine on serum NT-proBNP levels after 16 weeks of follow-up
SecondaryCorrelation between heart rate and NT-proBNP value (Pearson correlation) at the end of maintenanceAt the end of the two weeks maintenance period (17-29 days from enrollment)To assess the correlation between heart rate and serum NT-proBNP levels after 14 days of stable therapy
SecondaryCorrelation between heart rate and NT-proBNP value (Pearson correlation) at the end of follow-upAt the end of the 16 weeks follow-up period (129-141 days from enrollment)To assess the correlation between heart rate and serum NT-proBNP levels after 16 weeks of follow-up
SecondaryLeft ventricular function, calculated by 2D echocardiographic technique (calculation of left ventricular volume and ejection fraction - mean (±SD) difference from baseline) at the end of maintenanceAt the end of the two weeks maintenance period (17-29 days from enrollment)To assess EF, Left Ventricular End Diastolic Volume (LVEDV), Left Ventricular End Systolic Volume (LVESV) after 14 days of stable therapy
SecondaryLeft ventricular function, calculated by 2D echocardiographic technique (calculation of left ventricular volume and ejection fraction - mean (±SD) difference from baseline) at the end of follow-upAt the end of the 16 weeks follow-up period (129-141 days from enrollment)To assess EF, LVSV, LVDV after 16 weeks of follow-up
SecondarySystolic blood pressure in mmHg (mean (±SD) difference from baseline) at the end of maintenanceAt the end of the two weeks maintenance period (17-29 days from enrollment)To assess the response to ivabradine on systolic blood pressure after 14 days of stable therapy
SecondarySystolic blood pressure in mmHg (mean (±SD) difference from baseline) at the end of follow-upAt the end of the 16 weeks follow-up period (129-141 days from enrollment)To assess the response to ivabradine on systolic blood pressure after 16 weeks of follow-up
SecondaryUse of inotropic drugs (number and % of patients who had to use inotropes at the end of maintenance)At the end of the two weeks maintenance period (17-29 days from enrollment)To assess the need to resort to inotropic drugs within 14 days of stable ivabradine therapy
SecondaryUse of inotropic drugs (number and % of patients who had to use inotropes at the end of follow-up)At the end of the 16 weeks follow-up period (129-141 days from enrollment)To assess the need to resort to inotropic drugs within 16 weeks of follow-up
SecondaryNumber and % of dropouts at the end of maintenanceAt the end of the two weeks maintenance period (17-29 days from enrollment)To assess the frequency of patients who exit from the study within 14 days of stable ivabradine therapy
SecondaryNumber and % of dropouts at the end of follow-upAt the end of the 16 weeks follow-up period (129-141 days from enrollment)To assess the frequency of patients who exit from the study within 16 weeks of follow-up
SecondaryTime (days) from start of ivabradine therapy and new episode of acute heart failure, and/or implantation of mechanical assist device at the end of follow upAt the end of the 16 weeks follow-up period (129-141 days from enrollment)To assess the period within main cardiological events would occur after the start of ivabradine therapy

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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