Minimal Clinically Important Differences in 6-Minute Walk Test in Patients With HFrEF and Iron Deficiency |
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| Affiliation: | 1. Division of Cardiology, Duke University Medical Center, Durham, North Carolina, USA;2. Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin Berlin, Berlin, Germany;3. Department of Medical Statistics, University Medical Center Göttingen, Göttingen, Germany; German Center for Cardiovascular Research, Göttingen, Germany;4. Institute of Heart Diseases, Wroclaw Medical University Poland and Institute of Heart Diseases, University Hospital, Wroclaw, Poland;5. Cardiology, ASST Spedali Civili and Department of Medical and Surgical Specialties, Radiological Sciences, and Public Health, Civil Hospitals and University of Brescia, Brescia, Italy;6. Kimmel College of Medicine, Thomas Jefferson University, Philadelphia, Pennsylvania, USA;7. Heart Research Institute, Sydney, Australia;8. Centre for Clinical and Basic Research, Department of Medical Sciences, IRCCS San Raffaele Pisana, Rome, Italy;9. Vifor Pharma, Glattbrugg, Switzerland;10. Department of Cardiology, Bellvitge University Hospital and IDIBELL, University of Barcelona, Hospitalet de Llobregat, Barcelona, Spain;11. Department of Cardiology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands;12. University of Cyprus, Nicosia, Cyprus;13. National and Kapodistrian University of Athens, Athens University Hospital Attikon, Athens, Greece;14. Baylor Scott and White Research Institute, Dallas, Texas, USA;15. Department of Medicine, University of Mississippi Medical Center, Jackson, MS, USA |
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| Abstract: | BackgroundThe 6-minute walk test (6MWT) is widely used to measure exercise capacity; however, the magnitude of change that is clinically meaningful for individuals is not well established in heart failure with reduced ejection fraction (HFrEF).ObjectiveTo calculate the minimal clinically important difference (MCID) for change in exercise capacity in the 6MWT in iron-deficient populations with HFrEF.MethodsIn this pooled secondary analysis of the FAIR-HF and CONFIRM-HF trials, mean changes in the 6MWT from baseline to weeks 12 and 24 were calculated and calibrated against the Patient Global Assessment (PGA) tool (clinical anchor) to derive MCIDs in improvement and deterioration.ResultsOf 760 patients included in the 2 trials, 6MWT and PGA data were available for 680 (89%) and 656 (86%) patients at weeks 12 and 24, respectively. The mean 6MWT distance at baseline was 281 ± 103 meters. There was a modest correlation between changes in 6MWT and PGA from baseline to week 12 (r = 0.31; P < 0.0001) and week 24 (r = 0.43; P < 0.0001). Respective estimates (95% confidence intervals) of MCID in 6MWT at weeks 12 and 24 were 14 meters (5;23) and 15 meters (3;27) for a “little improvement” (vs no change), 20 meters (10;30) and 24 meters (12;36) for moderate improvement vs a “little improvement,”, -11 meters (-32;9.2) and -31 meters (-53;-8) for a “little deterioration” (vs no change), and -84 meters (-144;-24) and -69 meters (-118;-20) for “moderate deterioration” vs a “little deterioration”.ConclusionsThe MCID for improvement in exercise capacity in the 6MWT was 14 meters–15 meters in patients with HFrEF and iron deficiency. These MCIDs can aid clinical interpretation of study data. |
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