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Trial · NCT02617446

Registered outcomes26

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

ListOutcomeTime frameDescription
PrimaryChange in E/Ea Ratio24 hours
Change from baseline at 24 hours in the unitless ratio of E (cm/sec) to Ea (or e') (cm/sec) as measured by echocardiogram. The endpoint is the Tissue Doppler echocardiography showing measurement of mitral E/Ea ratio for assessment of diastolic dysfunction. Initially mitral E wave is measured. After that, color Tissue Doppler (tissue velocity imaging or TVI) mode is switched on to assess tissue Doppler. The cursor is placed over the medial mitral annulus and tissue Doppler tracing obtained. This allows Ea velocity to be measured. Higher values are suggestive of a worse outcome; less than 8 is normal.
SecondaryChange in LVEF24 hoursChange from baseline at 24 hours in LV ejection fraction (LVEF) by tissue Doppler
SecondaryChange in SVI24 hoursChange from baseline at 24 hours in stroke volume index (SVI) by tissue Doppler
SecondaryChange in E/A Ratio24 hoursChange from baseline at 24 hours in E/A ratio by tissue Doppler
SecondaryChange in LV End Systolic Volume24 hoursChange from baseline in left ventricular end systolic volume (LVESV) by tissue Doppler
SecondaryChange in LV End Diastolic Volume24 hoursChange from baseline in left ventricular end diastolic volume (LVEDV) by tissue Doppler
SecondaryChange in Dyspnea24 hoursMeasured using a visual analog scale (0 to 100). Higher scores indicate less dyspnea.
OtherChange in cTnT24 hoursSafety endpoint: Changes in troponin (cTnT)
OtherChange in eGFR24 HoursSafety endpoint: Change from baseline in estimated glomerular filtration rate (eGFR)
OtherParticipants With Clinically or Hemodynamically Significant Episodes of Arrhythmias24 hours
Safety endpoint: Number of participants with incidence of clinically or hemodynamically significant episodes of supraventricular or ventricular arrhythmias detected by continuous ECG dynamic monitoring
OtherPR Interval24 Hours
Safety Endpoint: The PR interval, measured in milliseconds, extends from the beginning of the P wave (the onset of atrial depolarization) until the beginning of the QRS complex (the onset of ventricular depolarization).
OtherQRS Duration24 hoursSafety endpoint: The quasi-random signal (QRS) duration represents the time for ventricular depolarization, normally 0.06 to 0.10 seconds.
OtherQTc Interval24 Hours
Safety Endpoint: The corrected QT interval (QTc) on an ECG represents the duration in milliseconds of the ventricular action potential, which physiologically correlates with the duration of the ventricular depolarization and repolarization.
OtherAll-Cause Mortality at Day 3030 daysSafety endpoint: Mortality at Day 30
OtherRBC - ShiftDay 3Safety endpoint: Baseline normal/abnormal to Day 3 normal/abnormal in red blood cells (RBC)
OtherHematocrit - ShiftDay 3Safety endpoint: Baseline normal/abnormal to Day 3 normal/abnormal in hematocrit
OtherHemoglobin - ShiftDay 3Safety endpoint: Baseline normal/abnormal to Day 3 normal/abnormal in hemoglobin
OtherWhite Blood Cells (WBC) - ShiftDay 3Safety endpoint: Baseline normal/abnormal to Day 3 normal/abnormal in WBC
OtherPlatelets - ShiftDay 3Safety endpoint: Baseline normal/abnormal to Day 3 normal/abnormal in platelets
OtherPotassium - ShiftDay 3Safety endpoint: Baseline normal/abnormal to Day 3 normal/abnormal in potassium

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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