Heart Failure with Preserved Ejection Fraction Trials Have Heterogeneous Control Groups: a Comparison of Kaplan-Meier Curves.
Cardiovasc Drugs Ther
; 32(6): 577-580, 2018 12.
Article
in En
| MEDLINE
| ID: mdl-30187346
ABSTRACT
PURPOSE:
Previous studies have evaluated intra-study heterogeneities of heart failure with preserved ejection fraction (HFpEF), but inter-study heterogeneities remain poorly understood. We investigate the heterogeneities of outcomes among control groups of HFpEF trials.METHODS:
We included randomized controlled trials recruiting HFpEF patients with ejection fraction ≥ 40% and reporting Kaplan-Meier curves for at least 36 months. The Kaplan-Meier curves of control groups were extracted and calculated for hazard ratios and 95% confidence intervals. Two virtual trials were developed to validate the reliability and accuracy of our method.RESULTS:
Of 4161 studies, we included six trials containing 7682 HFpEF patients in control groups. The DIG trial had the highest all-cause mortality, cardiovascular mortality, heart failure mortality, and composite endpoints of cardiovascular mortality and heart failure hospitalization (all p < 0.001). The TOPCAT trial had the lowest all-cause mortality, cardiovascular mortality, heart failure hospitalization, and composite of cardiovascular mortality and heart failure hospitalization (all p < 0.001). Adoption of different ejection fraction cut-off values for HFpEF diagnosis did not significantly change the outcomes of control groups in the DIG trial (45% vs. 50% hazard ratio, 1.05, 95% confidence interval, 0.97-1.13, p = 0.271), or in the CHARM-Preserved trial (40% vs. 50% hazard ratio, 1.01, 95% confidence interval, 0.93-1.09, p = 0.864) during 36-month follow-up.CONCLUSIONS:
The control groups of HFpEF trials have heterogeneous outcomes. Future trials should consider these heterogeneities when designing protocols.Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Research Design
/
Stroke Volume
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Randomized Controlled Trials as Topic
/
Ventricular Function, Left
/
Heart Failure
Type of study:
Clinical_trials
/
Diagnostic_studies
/
Etiology_studies
/
Guideline
/
Risk_factors_studies
Limits:
Aged
/
Female
/
Humans
/
Male
Language:
En
Journal:
Cardiovasc Drugs Ther
Journal subject:
ANGIOLOGIA
/
CARDIOLOGIA
/
TERAPIA POR MEDICAMENTOS
Year:
2018
Document type:
Article
Affiliation country:
China