Trial · NCT04405804
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Heart rate in b.p.m. (mean (±SD) difference from baseline) at the end of maintenance | At 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 |
| Secondary | Heart rate in b.p.m. (mean (±SD) difference from baseline) at the end of follow-up | At 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 |
| Secondary | Serum NT-proBNP in pg/mL (mean (±SD) difference from baseline) at the end of maintenance | At 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 |
| Secondary | Serum NT-proBNP in pg/mL (mean (±SD) difference from baseline) at the end of follow-up | At 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 |
| Secondary | Correlation between heart rate and NT-proBNP value (Pearson correlation) at the end of maintenance | At 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 |
| Secondary | Correlation between heart rate and NT-proBNP value (Pearson correlation) at the end of follow-up | At 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 |
| Secondary | Left ventricular function, calculated by 2D echocardiographic technique (calculation of left ventricular volume and ejection fraction - mean (±SD) difference from baseline) at the end of maintenance | At 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 |
| Secondary | Left 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-up | At 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 |
| Secondary | Systolic blood pressure in mmHg (mean (±SD) difference from baseline) at the end of maintenance | At 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 |
| Secondary | Systolic blood pressure in mmHg (mean (±SD) difference from baseline) at the end of follow-up | At 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 |
| Secondary | Use 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 |
| Secondary | Use 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 |
| Secondary | Number and % of dropouts at the end of maintenance | At 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 |
| Secondary | Number and % of dropouts at the end of follow-up | At 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 |
| Secondary | Time (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 up | At 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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