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Erschienen in: Clinical Research in Cardiology 10/2015

01.10.2015 | Original Paper

How does a clinical trial fit into the real world? The RELAX-AHF study population into the EAHFE registry

verfasst von: Òscar Miró, Víctor Gil, Christian Müller, Alexander Mebazaa, Héctor Bueno, Francisco Javier Martín-Sánchez, Pablo Herrero, Javier Jacob, Pere Llorens

Erschienen in: Clinical Research in Cardiology | Ausgabe 10/2015

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Abstract

Objective

To test how accurate the recently published RELAX-AHF trial was in recruiting real-world patients with acute-decompensated heart failure (ADHF).

Methods and results

We compared clinical and outcome data of patients receiving serelaxin in the RELAX-AHF trial (RELAX group, n = 581) with patients included in the EAHFE registry [5497 ADHF from 29 Spanish emergency departments (EDs)]. The EAHFE registry was split into two groups: EAHFE-non-RELAX (patients not fulfilling the RELAX-AHF inclusion criteria; n = 3205, 58.3 %) and EAHFE-RELAX A (patients fulfilling RELAX-AHF inclusion criteria; n = 2292, 41.7 %). The latter group was further refined by also applying exclusion criteria (EAHFE-RELAX B; n = 964, 17.4 %). Both EAHFE-RELAX groups differed from the EAHFE-non-RELAX group in multiple aspects, with the lower the proportion of patients with implantable cardiac defibrillator and with pulmonary diseases the greater the differences found. The RELAX group, compared with the EAHFE-RELAX groups, significantly included fewer females, younger patients, less in NYHA class I/II, less with implantable cardiac defibrillator and on beta-blocker treatment, and patients had lower systolic blood pressure and cardiac and respiratory rates at ED arrival. The EAHFE-RELAX groups had a significantly lower all-cause mortality than EAHFE-non-RELAX group, and qualitative analysis suggested that EAHFE-RELAX groups had a higher mortality than the RELAX group.

Conclusion

Patients included in the RELAX-AHF trial showed unanticipated differences when compared with a population from the EAHFE registry fulfilling very similar inclusion and exclusion criteria.
Literatur
1.
Zurück zum Zitat Akobeng AK (2008) Assessing the validity of clinical trials. J Pediatr Gastroenterol Nutr 47:277–282CrossRefPubMed Akobeng AK (2008) Assessing the validity of clinical trials. J Pediatr Gastroenterol Nutr 47:277–282CrossRefPubMed
2.
Zurück zum Zitat Niederseer D, Thaler CW, Niederseer M, Niebauer J (2013) Mismatch between heart failure patients in clinical trials and the real world. Int J Cardiol 168:1859–1865CrossRefPubMed Niederseer D, Thaler CW, Niederseer M, Niebauer J (2013) Mismatch between heart failure patients in clinical trials and the real world. Int J Cardiol 168:1859–1865CrossRefPubMed
3.
Zurück zum Zitat Westermann D, Kreutz R, Jacobshagen C (2014) Hotline update of clinical trials and registries presented at the American College of Cardiology Congress 2014. Clin Res Cardiol 103:591–597CrossRefPubMed Westermann D, Kreutz R, Jacobshagen C (2014) Hotline update of clinical trials and registries presented at the American College of Cardiology Congress 2014. Clin Res Cardiol 103:591–597CrossRefPubMed
4.
Zurück zum Zitat Muñoz García AJ, Sánchez González C, Jiménez Navarro MF, de Teresa Galván E (2005) Applicability of the clinical trials outcomes in heart failure to older people. Med Clin (Barc) 124:558CrossRef Muñoz García AJ, Sánchez González C, Jiménez Navarro MF, de Teresa Galván E (2005) Applicability of the clinical trials outcomes in heart failure to older people. Med Clin (Barc) 124:558CrossRef
5.
Zurück zum Zitat Llorens P, Martín-Sánchez FJ, González-Armengol JJ, Herrero P, Jacob J, Álvarez AB, Llorens Soriano P, Martín-Sánchez FJ, González Armengol JJ, Herrero Puente P, Jacob J, Bella Álvarez A et al (2008) Clinical profile of patients with acute heart failure in the emergency department: preliminary data from the EAHFE (Epidemiology Acute Heart Failure Emergency) study. Emergencias 20:154–163 Llorens P, Martín-Sánchez FJ, González-Armengol JJ, Herrero P, Jacob J, Álvarez AB, Llorens Soriano P, Martín-Sánchez FJ, González Armengol JJ, Herrero Puente P, Jacob J, Bella Álvarez A et al (2008) Clinical profile of patients with acute heart failure in the emergency department: preliminary data from the EAHFE (Epidemiology Acute Heart Failure Emergency) study. Emergencias 20:154–163
6.
Zurück zum Zitat Herrero-Puente P, Martín-Sánchez FJ, Fernández-Fernández M, Jacob J, Llorens P, Miró O et al (2012) Differential clinical characteristics and outcome predictors of acute heart failure in elderly patients. Int J Cardiol 155:81–86CrossRefPubMed Herrero-Puente P, Martín-Sánchez FJ, Fernández-Fernández M, Jacob J, Llorens P, Miró O et al (2012) Differential clinical characteristics and outcome predictors of acute heart failure in elderly patients. Int J Cardiol 155:81–86CrossRefPubMed
7.
Zurück zum Zitat Sánchez González M, Fernández Rodríguez A, Houghton García RF, Martínez Zapico A, Argüello Junquera M, Herrero Puente P (2013) Clinical profile and short-term prognosis of patients with acute heart failure under oral anticoagulant therapy. Emergencias 25:331–332 Sánchez González M, Fernández Rodríguez A, Houghton García RF, Martínez Zapico A, Argüello Junquera M, Herrero Puente P (2013) Clinical profile and short-term prognosis of patients with acute heart failure under oral anticoagulant therapy. Emergencias 25:331–332
8.
Zurück zum Zitat Teerlink JR, Cotter G, Davison BA, Felker GM, Filippatos G, Greenberg BH et al (2013) Serelaxin, recombinant human relaxin-2, for treatment of acute heart failure (RELAX-AHF): a randomised, placebo-controlled trial. Lancet 381:29–39CrossRefPubMed Teerlink JR, Cotter G, Davison BA, Felker GM, Filippatos G, Greenberg BH et al (2013) Serelaxin, recombinant human relaxin-2, for treatment of acute heart failure (RELAX-AHF): a randomised, placebo-controlled trial. Lancet 381:29–39CrossRefPubMed
9.
Zurück zum Zitat Ho KKL, Anderson KM, Kannel WB, Grosssman W, Levy D (1993) Survival after the onset of congestive heart failure in Framingham heart study subjects. Circulation 88:107–115CrossRefPubMed Ho KKL, Anderson KM, Kannel WB, Grosssman W, Levy D (1993) Survival after the onset of congestive heart failure in Framingham heart study subjects. Circulation 88:107–115CrossRefPubMed
10.
Zurück zum Zitat Scichilone N, Basile M, Battaglia S, Bellia V (2014) What proportion of chronic obstructive pulmonary disease outpatients is eligible for inclusion in randomized clinical trials? Respiration 87:11–17CrossRefPubMed Scichilone N, Basile M, Battaglia S, Bellia V (2014) What proportion of chronic obstructive pulmonary disease outpatients is eligible for inclusion in randomized clinical trials? Respiration 87:11–17CrossRefPubMed
11.
Zurück zum Zitat Travers J, Marsh S, Caldwell B, Williams M, Aldington S, Weatherall M, Shirtcliffe P, Beasley R (2007) External validity of randomized controlled trials in COPD. Respir Med 101:1313–1320CrossRefPubMed Travers J, Marsh S, Caldwell B, Williams M, Aldington S, Weatherall M, Shirtcliffe P, Beasley R (2007) External validity of randomized controlled trials in COPD. Respir Med 101:1313–1320CrossRefPubMed
12.
Zurück zum Zitat Masoudi FA, Havranek EP, Wolfe P et al (2003) Most hospitalized older persons do not meet the enrollment criteria for clinical trials in heart failure. Am Heart J 146:250–257CrossRefPubMed Masoudi FA, Havranek EP, Wolfe P et al (2003) Most hospitalized older persons do not meet the enrollment criteria for clinical trials in heart failure. Am Heart J 146:250–257CrossRefPubMed
13.
Zurück zum Zitat Lee DS, Schull MJ, Alter DA, Austin PC, Laupacis A, Chong A et al (2010) Early deaths in patients with heart failure discharged from the emergency department: a population-based analysis. Circ Heart Fail 3:228–235CrossRefPubMed Lee DS, Schull MJ, Alter DA, Austin PC, Laupacis A, Chong A et al (2010) Early deaths in patients with heart failure discharged from the emergency department: a population-based analysis. Circ Heart Fail 3:228–235CrossRefPubMed
14.
Zurück zum Zitat Murthy VH, Krumholz HM, Gross CP (2004) Participation in cancer clinical trials: race-sex-, and age-based disparities. JAMA 291:2720–2726CrossRefPubMed Murthy VH, Krumholz HM, Gross CP (2004) Participation in cancer clinical trials: race-sex-, and age-based disparities. JAMA 291:2720–2726CrossRefPubMed
15.
Zurück zum Zitat Wang TS, Hellkamp AS, Patel CB, Ezekowitz JA, Fonarow GC, Hernandez AF (2014) Representativeness of RELAX-AHF clinical trial population in acute heart failure. Circ Cardiovasc Qual Outcomes 7(2):259–268CrossRefPubMed Wang TS, Hellkamp AS, Patel CB, Ezekowitz JA, Fonarow GC, Hernandez AF (2014) Representativeness of RELAX-AHF clinical trial population in acute heart failure. Circ Cardiovasc Qual Outcomes 7(2):259–268CrossRefPubMed
16.
Zurück zum Zitat Zulman DM, Sussman JB, Chen X, Cigolle CT, Blaum CS, Hayward RA (2011) Examining the evidence: a systematic review of the inclusion and analysis of older adults in randomized controlled trials. J Gen Intern Med 26:783–790PubMedCentralCrossRefPubMed Zulman DM, Sussman JB, Chen X, Cigolle CT, Blaum CS, Hayward RA (2011) Examining the evidence: a systematic review of the inclusion and analysis of older adults in randomized controlled trials. J Gen Intern Med 26:783–790PubMedCentralCrossRefPubMed
17.
Zurück zum Zitat Martín-Sánchez FJ, Gil V, Llorens P, Herrero P, Jacob J, Fernández C, Acute Heart Failure Working Group of the Spanish Society of Emergency Medicine Investigation Group et al (2012) Barthel Index-Enhanced Feedback for Effective Cardiac Treatment (BI-EFFECT) Study: contribution of the Barthel Index to the Heart Failure Risk Scoring System model in elderly adults with acute heart failure in the emergency department. J Am Geriatr Soc 60:493–498CrossRefPubMed Martín-Sánchez FJ, Gil V, Llorens P, Herrero P, Jacob J, Fernández C, Acute Heart Failure Working Group of the Spanish Society of Emergency Medicine Investigation Group et al (2012) Barthel Index-Enhanced Feedback for Effective Cardiac Treatment (BI-EFFECT) Study: contribution of the Barthel Index to the Heart Failure Risk Scoring System model in elderly adults with acute heart failure in the emergency department. J Am Geriatr Soc 60:493–498CrossRefPubMed
18.
Zurück zum Zitat Martín-Sánchez FJ, Marino-Genicio R, Rodríguez-Adrada E, Jacob J, Herrero P, Miró O et al (2013) Management of acute heart failure in Spanish emergency departments based on age. Rev Esp Cardiol 66:715–720CrossRefPubMed Martín-Sánchez FJ, Marino-Genicio R, Rodríguez-Adrada E, Jacob J, Herrero P, Miró O et al (2013) Management of acute heart failure in Spanish emergency departments based on age. Rev Esp Cardiol 66:715–720CrossRefPubMed
19.
Zurück zum Zitat Ogah OS, Davison BA, Sliwa K, Mayosi BM, Damasceno A, Sani MU, et al (2015) Gender differences in clinical characteristics and outcome of acute heart failure in sub-Saharan Africa: results of the THESUS-HF study. Clin Res Cardiol (Epub ahead of print) Ogah OS, Davison BA, Sliwa K, Mayosi BM, Damasceno A, Sani MU, et al (2015) Gender differences in clinical characteristics and outcome of acute heart failure in sub-Saharan Africa: results of the THESUS-HF study. Clin Res Cardiol (Epub ahead of print)
20.
Zurück zum Zitat Riesgo A, Herrero P, Llorens P, Jacob J, Martín-Sánchez FJ, Bragulat E, en nombre del grupo EAFHE et al (2010) Influence of patient’s sex in the form of presentation and management of acute heart failure in Spanish emergency rooms. Med Clin (Barc) 134(15):671–677CrossRef Riesgo A, Herrero P, Llorens P, Jacob J, Martín-Sánchez FJ, Bragulat E, en nombre del grupo EAFHE et al (2010) Influence of patient’s sex in the form of presentation and management of acute heart failure in Spanish emergency rooms. Med Clin (Barc) 134(15):671–677CrossRef
21.
Zurück zum Zitat Seferovic PM, Stoerk S, Filippatos G, Mareev V, Kavoliuniene A, Ristic AD et al (2013) Organization of heart failure management in European Society of Cardiology member countries: survey of the Heart Failure Association of the European Society of Cardiology in collaboration with the Heart Failure National Societies/Working Groups. Eur J Heart Fail 15:947–959CrossRefPubMed Seferovic PM, Stoerk S, Filippatos G, Mareev V, Kavoliuniene A, Ristic AD et al (2013) Organization of heart failure management in European Society of Cardiology member countries: survey of the Heart Failure Association of the European Society of Cardiology in collaboration with the Heart Failure National Societies/Working Groups. Eur J Heart Fail 15:947–959CrossRefPubMed
22.
Zurück zum Zitat Collins SP, Levy PD, Pang PS, Gheorghiade M (2013) The role of the emergency department in acute heart failure clinical trials—enriching patient identification and enrollment. Am Heart J 165:902–909PubMedCentralCrossRefPubMed Collins SP, Levy PD, Pang PS, Gheorghiade M (2013) The role of the emergency department in acute heart failure clinical trials—enriching patient identification and enrollment. Am Heart J 165:902–909PubMedCentralCrossRefPubMed
23.
Zurück zum Zitat Martín-Sánchez FJ, Fernández Pérez C (2012) Clinical trial evidence comes to Emergencias: levosimendan in acute heart failure. Emergencias 24:265–267 Martín-Sánchez FJ, Fernández Pérez C (2012) Clinical trial evidence comes to Emergencias: levosimendan in acute heart failure. Emergencias 24:265–267
24.
Zurück zum Zitat Marino Genicio R (2013) Usefulness of mid-regional-proadrenomedullin and copeptin as predictors of 30-day mortality in patients with acute heart failure. Emergencias 25:328–329 Marino Genicio R (2013) Usefulness of mid-regional-proadrenomedullin and copeptin as predictors of 30-day mortality in patients with acute heart failure. Emergencias 25:328–329
25.
Zurück zum Zitat Llorens P, Miró O, Herrero P, Martín-Sánchez FJ, Jacob J, Valero A, et al Clinical effects and safety of different strategies for administering intravenous diuretics in acutely decompensated heart failure: a randomised clinical trial. Emerg Med J. doi:10.1136/emermed-2013-202526 Llorens P, Miró O, Herrero P, Martín-Sánchez FJ, Jacob J, Valero A, et al Clinical effects and safety of different strategies for administering intravenous diuretics in acutely decompensated heart failure: a randomised clinical trial. Emerg Med J. doi:10.​1136/​emermed-2013-202526
26.
Zurück zum Zitat Llorens P, Miró O, Román F, Zapater P, Carbajosa Dalmau J, Llanos L (2013) Efficacy of early administration of levosimendan in emergency department in patients with acute heart failure: a randomized pilot clinical trial. Emergencias 24:268–276 Llorens P, Miró O, Román F, Zapater P, Carbajosa Dalmau J, Llanos L (2013) Efficacy of early administration of levosimendan in emergency department in patients with acute heart failure: a randomized pilot clinical trial. Emergencias 24:268–276
27.
Zurück zum Zitat Llorens P, Herrero P, Miró Ò (2011) Diuretic strategies in patients with acute heart failure. N Engl J Med 364:2068–2069PubMed Llorens P, Herrero P, Miró Ò (2011) Diuretic strategies in patients with acute heart failure. N Engl J Med 364:2068–2069PubMed
28.
Zurück zum Zitat Chetta A, Olivieri D (2014) What we talk about when we talk about randomized controlled trials. Respiration 87:9–10CrossRefPubMed Chetta A, Olivieri D (2014) What we talk about when we talk about randomized controlled trials. Respiration 87:9–10CrossRefPubMed
29.
30.
Zurück zum Zitat O’Connor CM, Fiuzat M (2011) Clinical trials in acute decompensated heart failure—over 50 years of research. Heart Fail Clin 7:xv–xviiCrossRefPubMed O’Connor CM, Fiuzat M (2011) Clinical trials in acute decompensated heart failure—over 50 years of research. Heart Fail Clin 7:xv–xviiCrossRefPubMed
Metadaten
Titel
How does a clinical trial fit into the real world? The RELAX-AHF study population into the EAHFE registry
verfasst von
Òscar Miró
Víctor Gil
Christian Müller
Alexander Mebazaa
Héctor Bueno
Francisco Javier Martín-Sánchez
Pablo Herrero
Javier Jacob
Pere Llorens
Publikationsdatum
01.10.2015
Verlag
Springer Berlin Heidelberg
Erschienen in
Clinical Research in Cardiology / Ausgabe 10/2015
Print ISSN: 1861-0684
Elektronische ISSN: 1861-0692
DOI
https://doi.org/10.1007/s00392-015-0854-z

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