Mismatch between heart failure patients in clinical trials and the real world

Niederseer, David; Thaler, Christoph; Niederseer, Michaela C.; Niebauer, Josef

doi:10.1016/j.ijcard.2012.12.069

Cited by 22 publications

(17 citation statements)

References 29 publications

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“…Coca et al [5] found that individuals with renal disease were excluded in 56% of cardiovascular RCTs. Furthermore, only 13-25% of individuals from observational studies were estimated to be eligible for HF RCTs [22]. Patients included in our study were unselected patients treated in Norwegian outpatient HF clinics.…”

Section: Discussionmentioning

confidence: 99%

Spironolactone Treatment and Effect on Survival in Chronic Heart Failure Patients with Reduced Renal Function: A Propensity-Matched Study

Stubnova

Grundtvig

et al. 2017

Cardiorenal Med

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Background/Aims: Spironolactone may be hazardous in heart failure (HF) patients with renal dysfunction due to risk of hyperkalemia and worsened renal function. We aimed to evaluate the effect of spironolactone on all-cause mortality in HF outpatients with renal dysfunction in a propensity-score-matched study. Methods: A total of 2,077 patients from the Norwegian Heart Failure Registry with renal dysfunction (eGFR <60 mL/min/1.73 m²) not treated with spironolactone at the first visit at the HF clinic were eligible for the study. Patients started on spironolactone at the outpatient HF clinics (n = 206) were propensity-score-matched 1:1 with patients not started on spironolactone, based on 16 measured baseline characteristics. Kaplan-Meier and Cox regression analyses were used to investigate the independent effect of spironolactone on 2-year all-cause mortality. Results: Propensity score matching identified 170 pairs of patients, one group receiving spironolactone and the other not. The two groups were well matched (mean age 76.7 ± 8.1 years, 66.4% males, and eGFR 46.2 ± 10.2 mL/min/1.73 m²). Treatment with spironolactone was associated with increased potassium (delta potassium 0.31 ± 0.55 vs. 0.05 ± 0.41 mmol/L, p < 0.001) and decreased eGFR (delta eGFR -4.12 ± 12.2 vs. -0.98 ± 7.88 mL/min/1.73 m², p = 0.006) compared to the non-spironolactone group. After 2 years, 84% of patients were alive in the spironolactone group and 73% of patients in the non-spironolactone group (HR 0.59, 95% CI 0.37-0.92, p = 0.020). Conclusion: In HF outpatients with renal dysfunction, treatment with spironolactone was associated with improved 2-year survival compared to well-matched patients not treated with spironolactone. Favorable survival was observed despite worsened renal function and increased potassium in the spironolactone group.

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Section: Discussionmentioning

confidence: 99%

Spironolactone Treatment and Effect on Survival in Chronic Heart Failure Patients with Reduced Renal Function: A Propensity-Matched Study

Stubnova

Grundtvig

et al. 2017

Cardiorenal Med

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“…The reason for the conflicting results might be due to differences in the study populations and statistical methods. Randomized controlled trials include highly selected patients and also systematically exclude important subgroups of patients who are frequently seen in the daily practice [22]. It has been estimated that only 13-25% of HF patients from epidemiologic studies would be eligible for clinical HF trials [34,35].…”

Section: Discussionmentioning

confidence: 99%

“…However, such populations do not necessarily represent real-life patients because important subgroups are sometimes not included. Patients in clinical trials are often younger and have less comorbidity [22] than regular patients. Furthermore, there are less robust data with regard to the prognostic value of diabetes in HF patients with preserved ejection fraction, and the interaction between diabetes and ischemic etiology of HF remains under debate.…”

Section: Introductionmentioning

confidence: 99%

Prevalent Diabetes Mellitus: Mortality and Management in Norwegian Heart Failure Outpatients

Stubnova

Os²,

Grundtvig³

et al. 2016

Cardiology

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Objectives: Heart failure (HF) patients with diabetes mellitus experience poor prognosis. We assessed the independent predictive effect of prevalent diabetes mellitus on all-cause mortality in HF outpatients. Furthermore, we investigated if optimized HF medication differed in diabetic versus nondiabetic patients. Methods: From 6,289 patients included in the Norwegian HF registry during 2000-2012, 724 diabetic HF outpatients were propensity-score-matched with nondiabetic HF outpatients (1:1), based on 21 measured baseline variables. Baseline characteristics, measured comorbidities and medication were balanced in the matched sample. Results: Diabetes was not an independent predictor of all-cause mortality in the propensity-matched analyses (hazard ratio 1.041; 95% confidence interval 0.875-1.240). No interactions were found between the prognostic impact of diabetes and the strata renal function, systolic function or etiology of chronic HF. Diabetic HF outpatients were independently prescribed higher doses of β-blockers and loop diuretics (both p < 0.001) and were more prone to receive statins (p = 0.003) than nondiabetics. Conclusions: Prevalent diabetes mellitus was not an independent predictor of all-cause mortality in HF outpatients. Explanations other than tight glycemic control should be assessed to improve the prognosis of diabetic HF outpatients. The more intensive, optimized HF medication for diabetic HF outpatients may, to a certain degree, explain our results.

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“…A final limitation common to cardiac rehabilitation and ET trials was that a majority of HFrEF patients in this analysis were males (77%). 44,45 Thus, it is unclear if these findings extend to older female HFrEF patients. Despite these limitations, and unlike our 2007 meta-analysis using the same search strategy, 6 the majority of the subjects in the trials included in this updated analysis were on evidence-based HF therapy, and most of the investigators performing the outcome measure analysis were blinded to group allocation.…”

Section: Study Limitationsmentioning

confidence: 99%

Meta-analysis of Exercise Training on Left Ventricular Ejection Fraction in Heart Failure with Reduced Ejection Fraction: A 10-year Update

Tucker

Beaudry

Liang

et al. 2019

Progress in Cardiovascular Diseases

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Mismatch between heart failure patients in clinical trials and the real world

Cited by 22 publications

References 29 publications

Spironolactone Treatment and Effect on Survival in Chronic Heart Failure Patients with Reduced Renal Function: A Propensity-Matched Study

Spironolactone Treatment and Effect on Survival in Chronic Heart Failure Patients with Reduced Renal Function: A Propensity-Matched Study

Prevalent Diabetes Mellitus: Mortality and Management in Norwegian Heart Failure Outpatients

Meta-analysis of Exercise Training on Left Ventricular Ejection Fraction in Heart Failure with Reduced Ejection Fraction: A 10-year Update

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