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June 13, 2012CirculationOpen Access

Validation of 6-Minute Walk Distance as a Surrogate End Point in Pulmonary Arterial Hypertension Trials

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Why the study?

Is the change in 6-minute walk distance a valid surrogate endpoint for clinical events in pulmonary arterial hypertension trials?

Population

Patients in Pulmonary Arterial Hypertension trials

Design

Other

Authors

NGNicole B. GablerBFBenjamin FrenchBSBrian L. Strom

Discussion

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Overview

May limit reliance on 6MWD for PAH treatment decisions; challenges its surrogate validity in future trials.

Structured PICO

Is the change in 6-minute walk distance a valid surrogate endpoint for clinical events in pulmonary arterial hypertension trials?

P
Population
Patients in Pulmonary Arterial Hypertension trials
I
Intervention
Change in 6-Minute Walk Distance (Δ6MWD) as a surrogate endpoint
O
Outcome
Validity of Δ6MWD as a surrogate end point for clinical eventssurrogate

Change in 6-minute walk distance has only modest validity and may not be a sufficient surrogate endpoint for clinical events in pulmonary arterial hypertension trials.

Limitations

  • Unclear if the threshold value of 41.8 m is valid for long-term outcomes
  • Unclear if validity differs among trials using background therapy or lacking placebo controls entirely

Cite This Study

Gabler et al. (2012) studied this question.

synapsesocial.com/papers/69d76209ef4aa71f97f31103https://doi.org/10.1161/circulationaha.112.105890
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