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April 29, 2016European Journal of Heart Failure205 citationsOpen Access

A Systems BIOlogy Study to TAilored Treatment in Chronic Heart Failure: Rationale, Design, and Baseline Characteristics of BIOSTAT-CHF

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AVAdriaan A. VoorsSAStefan D. AnkerJCJohn G.F. Cleland

Key Result

The BIOSTAT-CHF study successfully recruited 4,254 patients with worsening heart failure to develop a systems biology model predicting individualized response to guideline-recommended therapies.

Study Design

Type

Observational (n=4,254)

Multicenter

Yes

Structured PICO

Can a systems biology approach predict response to therapy in patients with worsening heart failure on suboptimal medical treatment?

P
Population
4,254 patients with worsening signs and/or symptoms of heart failure considered to be on suboptimal medical treatment (2,516 in the index cohort from 11 European countries and 1,738 in the validation cohort from Scotland). Approximately half were in NYHA class III.
I
Intervention
Uptitration to guideline-recommended doses of heart failure therapy combined with a systems biology approach incorporating demographics, biomarkers, genome-wide analysis, and proteomics.
O
Outcome
Development of a model that predicts response to therapy

The BIOSTAT-CHF study aims to use a systems biology approach to develop a model predicting response to heart failure therapy in patients with worsening symptoms on suboptimal treatment.

Limitations

  • ACE inhibitors, ARBs, and beta-blockers are not guideline-recommended therapies in patients with heart failure with preserved ejection fraction (HFpEF), who were included in the study.

Abstract

AIMS: Despite major improvements in pharmacological and device treatments, heart failure remains a syndrome with high morbidity and mortality, poor quality of life, and high health-care costs. Given the extensive heterogeneity among patients with heart failure, substantial differences in the response to therapy can be expected. We hypothesize that individualized therapy is an essential next step to improve outcomes in patients with heart failure. METHODS: The BIOlogy Study to TAilored Treatment in Chronic Heart Failure (BIOSTAT-CHF) included 2516 patients with worsening signs and/or symptoms of heart failure from 11 European countries, who were considered to be on suboptimal medical treatment. Another 1738 patients from Scotland were included in a validation cohort. Overall, both patient cohorts were well matched. The majority of patients were hospitalized for acute heart failure, and the remainder presented with worsening signs and/or symptoms of heart failure at outpatient clinics. Approximately half of the patients were in New York Heart Association class III, and 7% vs 34% of patients of the index vs validation cohort had heart failure with preserved ejection fraction. According to study design, all patients used diuretics, but owing to the inclusion criteria of both cohorts, patients were not on optimal, evidence-based medical therapy. In the follow-up phase, uptitration to guideline-recommended doses was encouraged. CONCLUSION: By using a novel systems biology approach, incorporating demographics, biomarkers, genome-wide analysis, and proteomics, a model that predicts response to therapy will be developed, which should be instrumental in developing alternative therapies for patients with suboptimal response to currently recommended therapies and thus further improve care for patients with heart failure.

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Cite This Study

Voors et al. (2016) conducted an observational in Chronic Heart Failure (n=4,254). Guideline-recommended pharmacological therapy (ACE inhibitors/ARBs and beta-blockers) was evaluated on Time to a composite of death or unscheduled hospitalizations for heart failure. The BIOSTAT-CHF study successfully recruited 4,254 patients with worsening heart failure to develop a systems biology model predicting individualized response to guideline-recommended therapies.

synapsesocial.com/papers/6a09093abee8d5ab8a92dc74https://doi.org/10.1002/ejhf.531
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