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December 1, 2004Pacing and Clinical Electrophysiology

Sample Size, Power Calculations, and Their Implications for the Cost of Thorough Studies of Drug Induced QT Interval Prolongation

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Population

57 healthy subjects (26 women, age range 19-42 years)

Comparison

Seven different levels of QT/RR data quality… vs Simple measurement approaches with ad-hoc heart…

Design

Other

Authors

MMMarek MalikElectrophysiologyKHKaterina HnatkovaElectrophysiologyVBVelislav N. BatchvarovElectrophysiology

Discussion

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Implication

May reduce QTc study sample sizes and costs; extends methods but leaves open adoption without prospective validation.

Structured PICO

P
Population
57 healthy subjects (26 women, age range 19-42 years)
I
Intervention
Seven different levels of QT/RR data quality combined with eight different heart rate corrections (ranging from Bazett/Fridericia to individual QT/RR regression modelling)
C
Comparator
Simple measurement approaches with ad-hoc heart rate correction (e.g., measuring 3 beats in one ECG lead)
O
Outcome
Standard deviation of individual mean QTc values and mean of individual standard deviations of QTc values, used to derive the required sample size to detect 5 ms QTc changes with 80% powersurrogate

Employing stringent ECG measurement and individualized heart rate correction can substantially reduce the required sample size and cost of thorough QT/QTc studies.

Cite This Study

Malik et al. (2004) studied this question.

synapsesocial.com/papers/6a73b1d6d3d4e530dbfb792chttps://doi.org/10.1111/j.1540-8159.2004.00701.x
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Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

  1. 1Differences Between Study‐Specific and Subject‐Specific Heart Rate Corrections of the QT Interval in Investigations of Drug Induced QTc Prolongation2004 · 65 citations
  2. 2Linearly Scaled, Rate‐Invariant Normal Limits for QT Interval: Eight Decades of Incorrect Application of Power Functions2002 · 117 citations
  3. 3Drug‐Induced Torsades de Pointes and Implications for Drug Development2004 · 347 citations
  4. 4Problems of Heart Rate Correction in Assessment of Drug‐Induced QT Interval Prolongation2001 · 279 citations
  5. 5QT-RR relationship in healthy subjects exhibits substantial intersubject variability and high intrasubject stability2002 · 223 citations