The utility of heart failure registries: a descriptive and comparative study of two heart failure registries

Miró, Òscar; Martín‐Sánchez, Francisco Javier; Montero-Pérez-Barquero, Manuel; Jacob, Javier; Quirós-López, Raúl; Puente, Pablo Herrero; Llorens, Pere; Anarte, L.; Aramburu, Óscar; Arévalo‐Lorido, J.C.; Baş, Ferruh; Carrera, Margarita; Cerqueiro, J.M.; Conde, Alicia; Dávila, M.F.; Díez, José Miguel Baena; Formiga, Francesç; González, A.; Guisado, M.; Herrero, Agustín; Manzano, Luís; Martínez, Araceli Díaz; Montero, Manuel; Murado, I.; Oropesa, Roberto; Pérez, J I Garrido; Quesada, Miguel A.; Quirós, Raúl Guzmán; Ruiz, R; Salamanca, Patricia; Sánchez, Mónica Torres; Satué, J.A.; Serrado, A.; Suárez, Isabelle; Trullàs, Joan Carles; Fuentes, Marta; Valles, José Manuel González y Fernández; Gil, Víctor; Escoda, Rosa; Pavón, José; Álvarez, Antonia; Noval, Antonio; Torres, José Manuel; López‐Grima, María Luisa; Valero, Amparo; Aguirre, Alfons; Sancho, H; Ruiz, Paloma Gallar; Giménez, Antonio; Franco, Jonathan; Pardo, Sergio; Mecina, Ana Belén; Tost, Josep; Fabregat, Jordi; Epelde, Francisco; Sánchez, Susana; Piñera, Pascual; Garate, Raquel Torres; Alquézar, Aitor; Rizzi, Miguel Alberto; Richard, Fernando; Lucas, Javier; Cabello, Irene

doi:10.1136/postgradmedj-2015-133739

Cited by 24 publications

(8 citation statements)

References 24 publications

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“…In online supplementary , we describe the baseline characteristics of patients enrolled in Phase 2 and 3 trials 1–6,43 compared to registries in AHF 44–52 in which there was no eligibility restriction with reference to left ventricular ejection fraction or other requirement for ‘documented cardiac dysfunction’. As the table shows, some characteristics of patients in Phase 2 and Phase 3 trials showed lesser or greater degrees of similarity with those of registry patients (highlighted in green); however, there is no specific pattern showing that findings in Phase 3 trials are more similar to registry results than those in Phase 2 trials.…”

Section: Resultsmentioning

confidence: 99%

“…Overall proportions are presented for categorical variables; overall means for continuous variables were calculated by weighting each trial's mean by the trial's sample size. These overall characteristics were then compared with the characteristics of patients enrolled in AHF registries 44–52 …”

Section: Methodsmentioning

confidence: 99%

“…These overall characteristics were then compared with the characteristics of patients enrolled in AHF registries. [44][45][46][47][48][49][50][51][52] Assessing placebo event rates and treatment effects in chronic and acute heart failure trials…”

Section: Assessing the Similarity Of Clinical Trials And Registriesmentioning

confidence: 99%

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Mega‐trials in heart failure: effects of dilution in examination of new therapies

Davison

Takagi

Senger

et al. 2020

European J of Heart Fail

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Section: Resultsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

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Mega‐trials in heart failure: effects of dilution in examination of new therapies

Davison

Takagi

Senger

et al. 2020

European J of Heart Fail

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“…It should be noted that the definition of chronic CAD encompasses a wide spectrum of patients, and their outcomes are highly dependent on the clinical setting and entry criteria (hospitalized vs. ambulatory patients, inclusion of patients with HF, etc.). Trullas et al 27 showed that in the registry setting, even in patients with similar clinical characteristics, HF outcomes may significantly differ. Therefore, in the case of a complex and heterogeneous disease such as HF, the results of registries must be interpreted with caution.…”

Section: Discussionmentioning

confidence: 99%

Incident heart failure in outpatients with chronic coronary syndrome: results from the international prospective CLARIFY registry

Parma

Jasilek

Greenlaw

et al. 2020

European J of Heart Fail

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Aim The contemporary incidence of heart failure (HF) in patients with chronic coronary syndrome is unclear. We aimed to study the incidence and predictors of cardiovascular (CV) death, HF hospitalization or new‐onset HF not requiring hospitalization, in patients included in the CLARIFY registry. Methods and results CLARIFY is a contemporary, international registry of ambulatory patients with chronic coronary artery disease, conducted in 45 countries. At baseline, data on demographics, ethnicity, CV risk factors, medical history, cardiac parameters and medication were collected. Patients were followed up yearly up to 5 years. In this analysis, 26 769 patients with no HF history were included. At 5‐year follow‐up, 4393 patients (16.4%) reached the primary endpoint comprising CV death, HF hospitalization, or new‐onset HF. Only 16.7% of them (n = 732) required hospitalization for HF. All‐cause death occurred in 6.6% of patients (61.4% were CV). Age over 70 years, left ventricular ejection fraction <50%, Canadian Cardiovascular Society class ≥2 angina, atrial fibrillation or paced rhythm on the ECG, body mass index <20 kg/m2, and a history of stroke, were the most robust predictors of the primary outcome. Age <50 years, Asian ethnicity, and percutaneous revascularization were negative predictors of the outcome. Conclusion A sizeable proportion of patients with chronic coronary syndrome develop HF, which only infrequently requires hospitalization. Early identification of patients with HF may lead to early treatment, and help to further decrease mortality and morbidity. This concept needs confirmation in future studies.

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“…Despite the acknowledged value of RWD there is still a lack of understanding of its scope in generating evidence for treatments in addition to RCTs. To our knowledge current usage of RWD for HF has not yet been systematically evaluated [ [10] , [11] , [12] ]. Organisation for Economic Co-operation and Development (OECD) member countries have the world's highest level of adherence to evidence-based chronic HF therapies, primarily in North America, Western Europe, and Japan [ 13 ] and are pioneering access and implementation of RWD for decision-makers and various stakeholders in healthcare [ 14 ].…”

Section: Introductionmentioning

confidence: 99%

Utilisation of real-world data from heart failure registries in OECD countries - A systematic review

Khamitova

Kyhlstedt

et al. 2018

IJC Heart & Vasculature

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BackgroundHeart failure represents a major public health issue that impacts 26 million people globally. Currently, real-world data represents a key instrument for providing the verification of both internal and external validity, yet there is still a lack of understanding regarding its scope in complementing evidence of treatments for heart failure. This study aims to increase understanding of the utilisation of real-word data from heart failure registries in Organisation for Economic Co-operation and Development (OECD) countries.MethodThis was a systematic review of existing observational studies from heart failure registries in 35 OECD member countries. Studies from 2000 to March 2017 were identified through electronic databases (MEDLINE (Ovid), EMBASE, Web of Science Core Collection, CINAHL (Ebsco), Cochrane CENTRAL) and appraised according to eligibility criteria.ResultsTwo-hundred and two studies met the inclusion criteria, in which the majority were published from 2013 to 2016. All 202 studies were observational, among which 98% were cohort studies (198). The median sample size of all studies was 5152 (2417 to 32,890) and median study period 55 months (33.0 to 72.0). Swedish heart failure registry had the most publications (24, 12%).ConclusionSince 2000 there has been an upward trend in the number of published observational studies on heart failure registries in OECD countries with increasingly diverse outcomes and advanced statistical methods to improve their validity and reliability. This indicates that the utilisation of real-world data has experienced a significant upsurge in complementing the findings of clinical trials for improved research of heart failure treatments.

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The utility of heart failure registries: a descriptive and comparative study of two heart failure registries

Abstract: We found differences in the clinical characteristics of patients admitted to Spanish internal medicine wards for decompensated HF depending on inclusion in either the RICA or EAHFE registry.

Cited by 24 publications

References 24 publications

Mega‐trials in heart failure: effects of dilution in examination of new therapies

Mega‐trials in heart failure: effects of dilution in examination of new therapies

Incident heart failure in outpatients with chronic coronary syndrome: results from the international prospective CLARIFY registry

Utilisation of real-world data from heart failure registries in OECD countries - A systematic review

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