Left Ventricular Assist Device Outcomes In Patients With Chronic Kidney Disease And End-stage Renal Disease
HFSA ePoster Library. Dalia T. 09/10/21; 343375; 150
Tarun Dalia
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Abstract
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Background: We aimed to determine the placebo effect in patients with heart failure (HF) on 6-minute walk test distance (6MWT) and peak oxygen consumption (Peak VO2).
Methods: A systematic search of the MEDLINE database identified randomized controlled trials (RCTs) that evaluated 6MWT and peak VO2 in patients with HF in the contemporary era, between January 2015 and December 2020.
Results: A review of 173 studies from a MEDLINE search, with full text review, yielded 38 double-blind placebo controlled RCTs with availability of either raw or percent change in 6MWT across the trial. There were 2,713 patients (63% male, average age 66 years) with HF (NYHA class I - 2%, class II - 52%, class III - 43%, class IV - 3 %) randomized to the placebo arm. At the completion of the trials (median duration 24.5 weeks, range 5 days to 108 weeks) the mean 6MWT % change was + 4.2 +/- 12.9 %. 28 of 38 studies reported a 6MWT increase, and 10 reported a decrease. Mean 6MWT % change in trials of duration < 24.5 weeks (n=19) was 7.8 +/- 12.9 %, whereas mean 6MWT % change in trials > 24.5 weeks (n=19) was 0.7 +/- 12.5 % (p < 0.001 vs. < 24.5 weeks). 12 trials included only patients with HF with preserved ejection fraction (HFpEF), 18 included only patients with HF with reduced ejection fraction (HFrEF), and 8 included both. The 12 trials with HFpEF patients had a total of 894 patients and had a mean 6MWT % change of 6.9 +/- 6.2%. The 18 trials with HFrEF patients had a total of 1203 patients and had a mean 6MWT % change of 5.5 +/- 11.5 % (p<0.001 vs. HFpEF)
Also identified were 22 double-blind placebo controlled RCTs with changes in peak VO2. There were 1,092 patients (51% male, average age of 65 years) with HF (NYHA class II - 62%, NYHA class III - 38%) randomized to the placebo arm. At trial completion (median duration 12 weeks, range 1-104 weeks) the mean Peak VO2 % change was -0.6 +/- 5.2%. 13 of 22 studies reported a Peak VO2 increase, and 9 reported a decrease. Mean Peak VO2 change in trials of duration ≤ 12 weeks (n=12) was 1.3 +/- 4%, whereas in trials that lasted > 12 weeks (n = 10) it was -1.7 +/- 5.9 % (p < 0.001 vs. ≤ 12 weeks). 14 trials included only patients with HFpEF, 7 included only patients with HFrEF, and 1 included both. The 14 trials with HFpEF patients had a total of 734 patients and had a mean Peak VO2 % change of 0.83 +/- 3.2%. The 12 trials with HFrEF patients had a total of 334 patients and had a mean Peak VO2 % change of -4.4 +/- 6.5 % (p<0.001 vs. HFpEF)
Conclusion: In contemporary RCTs in patients with HF, 6MWT and Peak VO2 responses in the placebo-group arm have wide variability, may increase or decrease, are different in patients with HFpEF or HFrEF, and are associated with the duration of the trial. These results can inform a more quantitative approach to sample size and trial duration determination for trials involving functional and exercise capacity endpoints.
Methods: A systematic search of the MEDLINE database identified randomized controlled trials (RCTs) that evaluated 6MWT and peak VO2 in patients with HF in the contemporary era, between January 2015 and December 2020.
Results: A review of 173 studies from a MEDLINE search, with full text review, yielded 38 double-blind placebo controlled RCTs with availability of either raw or percent change in 6MWT across the trial. There were 2,713 patients (63% male, average age 66 years) with HF (NYHA class I - 2%, class II - 52%, class III - 43%, class IV - 3 %) randomized to the placebo arm. At the completion of the trials (median duration 24.5 weeks, range 5 days to 108 weeks) the mean 6MWT % change was + 4.2 +/- 12.9 %. 28 of 38 studies reported a 6MWT increase, and 10 reported a decrease. Mean 6MWT % change in trials of duration < 24.5 weeks (n=19) was 7.8 +/- 12.9 %, whereas mean 6MWT % change in trials > 24.5 weeks (n=19) was 0.7 +/- 12.5 % (p < 0.001 vs. < 24.5 weeks). 12 trials included only patients with HF with preserved ejection fraction (HFpEF), 18 included only patients with HF with reduced ejection fraction (HFrEF), and 8 included both. The 12 trials with HFpEF patients had a total of 894 patients and had a mean 6MWT % change of 6.9 +/- 6.2%. The 18 trials with HFrEF patients had a total of 1203 patients and had a mean 6MWT % change of 5.5 +/- 11.5 % (p<0.001 vs. HFpEF)
Also identified were 22 double-blind placebo controlled RCTs with changes in peak VO2. There were 1,092 patients (51% male, average age of 65 years) with HF (NYHA class II - 62%, NYHA class III - 38%) randomized to the placebo arm. At trial completion (median duration 12 weeks, range 1-104 weeks) the mean Peak VO2 % change was -0.6 +/- 5.2%. 13 of 22 studies reported a Peak VO2 increase, and 9 reported a decrease. Mean Peak VO2 change in trials of duration ≤ 12 weeks (n=12) was 1.3 +/- 4%, whereas in trials that lasted > 12 weeks (n = 10) it was -1.7 +/- 5.9 % (p < 0.001 vs. ≤ 12 weeks). 14 trials included only patients with HFpEF, 7 included only patients with HFrEF, and 1 included both. The 14 trials with HFpEF patients had a total of 734 patients and had a mean Peak VO2 % change of 0.83 +/- 3.2%. The 12 trials with HFrEF patients had a total of 334 patients and had a mean Peak VO2 % change of -4.4 +/- 6.5 % (p<0.001 vs. HFpEF)
Conclusion: In contemporary RCTs in patients with HF, 6MWT and Peak VO2 responses in the placebo-group arm have wide variability, may increase or decrease, are different in patients with HFpEF or HFrEF, and are associated with the duration of the trial. These results can inform a more quantitative approach to sample size and trial duration determination for trials involving functional and exercise capacity endpoints.
Background: We aimed to determine the placebo effect in patients with heart failure (HF) on 6-minute walk test distance (6MWT) and peak oxygen consumption (Peak VO2).
Methods: A systematic search of the MEDLINE database identified randomized controlled trials (RCTs) that evaluated 6MWT and peak VO2 in patients with HF in the contemporary era, between January 2015 and December 2020.
Results: A review of 173 studies from a MEDLINE search, with full text review, yielded 38 double-blind placebo controlled RCTs with availability of either raw or percent change in 6MWT across the trial. There were 2,713 patients (63% male, average age 66 years) with HF (NYHA class I - 2%, class II - 52%, class III - 43%, class IV - 3 %) randomized to the placebo arm. At the completion of the trials (median duration 24.5 weeks, range 5 days to 108 weeks) the mean 6MWT % change was + 4.2 +/- 12.9 %. 28 of 38 studies reported a 6MWT increase, and 10 reported a decrease. Mean 6MWT % change in trials of duration < 24.5 weeks (n=19) was 7.8 +/- 12.9 %, whereas mean 6MWT % change in trials > 24.5 weeks (n=19) was 0.7 +/- 12.5 % (p < 0.001 vs. < 24.5 weeks). 12 trials included only patients with HF with preserved ejection fraction (HFpEF), 18 included only patients with HF with reduced ejection fraction (HFrEF), and 8 included both. The 12 trials with HFpEF patients had a total of 894 patients and had a mean 6MWT % change of 6.9 +/- 6.2%. The 18 trials with HFrEF patients had a total of 1203 patients and had a mean 6MWT % change of 5.5 +/- 11.5 % (p<0.001 vs. HFpEF)
Also identified were 22 double-blind placebo controlled RCTs with changes in peak VO2. There were 1,092 patients (51% male, average age of 65 years) with HF (NYHA class II - 62%, NYHA class III - 38%) randomized to the placebo arm. At trial completion (median duration 12 weeks, range 1-104 weeks) the mean Peak VO2 % change was -0.6 +/- 5.2%. 13 of 22 studies reported a Peak VO2 increase, and 9 reported a decrease. Mean Peak VO2 change in trials of duration ≤ 12 weeks (n=12) was 1.3 +/- 4%, whereas in trials that lasted > 12 weeks (n = 10) it was -1.7 +/- 5.9 % (p < 0.001 vs. ≤ 12 weeks). 14 trials included only patients with HFpEF, 7 included only patients with HFrEF, and 1 included both. The 14 trials with HFpEF patients had a total of 734 patients and had a mean Peak VO2 % change of 0.83 +/- 3.2%. The 12 trials with HFrEF patients had a total of 334 patients and had a mean Peak VO2 % change of -4.4 +/- 6.5 % (p<0.001 vs. HFpEF)
Conclusion: In contemporary RCTs in patients with HF, 6MWT and Peak VO2 responses in the placebo-group arm have wide variability, may increase or decrease, are different in patients with HFpEF or HFrEF, and are associated with the duration of the trial. These results can inform a more quantitative approach to sample size and trial duration determination for trials involving functional and exercise capacity endpoints.
Methods: A systematic search of the MEDLINE database identified randomized controlled trials (RCTs) that evaluated 6MWT and peak VO2 in patients with HF in the contemporary era, between January 2015 and December 2020.
Results: A review of 173 studies from a MEDLINE search, with full text review, yielded 38 double-blind placebo controlled RCTs with availability of either raw or percent change in 6MWT across the trial. There were 2,713 patients (63% male, average age 66 years) with HF (NYHA class I - 2%, class II - 52%, class III - 43%, class IV - 3 %) randomized to the placebo arm. At the completion of the trials (median duration 24.5 weeks, range 5 days to 108 weeks) the mean 6MWT % change was + 4.2 +/- 12.9 %. 28 of 38 studies reported a 6MWT increase, and 10 reported a decrease. Mean 6MWT % change in trials of duration < 24.5 weeks (n=19) was 7.8 +/- 12.9 %, whereas mean 6MWT % change in trials > 24.5 weeks (n=19) was 0.7 +/- 12.5 % (p < 0.001 vs. < 24.5 weeks). 12 trials included only patients with HF with preserved ejection fraction (HFpEF), 18 included only patients with HF with reduced ejection fraction (HFrEF), and 8 included both. The 12 trials with HFpEF patients had a total of 894 patients and had a mean 6MWT % change of 6.9 +/- 6.2%. The 18 trials with HFrEF patients had a total of 1203 patients and had a mean 6MWT % change of 5.5 +/- 11.5 % (p<0.001 vs. HFpEF)
Also identified were 22 double-blind placebo controlled RCTs with changes in peak VO2. There were 1,092 patients (51% male, average age of 65 years) with HF (NYHA class II - 62%, NYHA class III - 38%) randomized to the placebo arm. At trial completion (median duration 12 weeks, range 1-104 weeks) the mean Peak VO2 % change was -0.6 +/- 5.2%. 13 of 22 studies reported a Peak VO2 increase, and 9 reported a decrease. Mean Peak VO2 change in trials of duration ≤ 12 weeks (n=12) was 1.3 +/- 4%, whereas in trials that lasted > 12 weeks (n = 10) it was -1.7 +/- 5.9 % (p < 0.001 vs. ≤ 12 weeks). 14 trials included only patients with HFpEF, 7 included only patients with HFrEF, and 1 included both. The 14 trials with HFpEF patients had a total of 734 patients and had a mean Peak VO2 % change of 0.83 +/- 3.2%. The 12 trials with HFrEF patients had a total of 334 patients and had a mean Peak VO2 % change of -4.4 +/- 6.5 % (p<0.001 vs. HFpEF)
Conclusion: In contemporary RCTs in patients with HF, 6MWT and Peak VO2 responses in the placebo-group arm have wide variability, may increase or decrease, are different in patients with HFpEF or HFrEF, and are associated with the duration of the trial. These results can inform a more quantitative approach to sample size and trial duration determination for trials involving functional and exercise capacity endpoints.
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