Literature DB >> 24594552

Representativeness of RELAX-AHF clinical trial population in acute heart failure.

Teresa S Wang1, Anne S Hellkamp, Chetan B Patel, Justin A Ezekowitz, Gregg C Fonarow, Adrian F Hernandez.   

Abstract

BACKGROUND: The Relaxin for the Treatment of Acute Heart Failure (RELAX-AHF) trial enrolled 1161 patients admitted to the hospital for acute heart failure (AHF) to evaluate the therapeutic efficacy of serelaxin, a recombinant form of human relaxin-2. We characterized how representative RELAX-AHF clinical trial enrollees were to those patients with AHF found in international registries. METHODS AND
RESULTS: We examined 196 770 AHF admissions from the Acute Decompensated Heart Failure National Registry-United States and Acute Decompensated Heart Failure National Registry-International registries. Patients were considered RELAX-AHF-type if they met the following criteria: discharge diagnosis of heart failure, systolic blood pressure >125 mm Hg, dyspnea at rest or with mild exertion, intravenous diuretic use, glomerular filtration rate of 30 to 75 mL/min per 1.73 m(2), hemoglobin >8 g/dL, and no use of intravenous inotropes or vasopressors. Baseline characteristics and treatments of RELAX-AHF-type and non-RELAX-AHF-type patients were compared. A Cox model was used to evaluate inpatient mortality. Among both Acute Decompensated Heart Failure National Registry-United States and Acute Decompensated Heart Failure National Registry-International registries, 20.7% (n=38 485) and 16.2% (n=1749) of patients met basic criteria for RELAX-AHF entry, respectively. These patients were more likely to be older, be women, have a previous history of hypertension, have preserved ejection fraction, and have better renal function. In-hospital mortality was lower in RELAX-AHF-type than in non-RELAX-AHF-type patients, even after multivariable adjustment (hazard ratio, 0.59; 95% confidence interval, 0.53-0.66; P<0.0001).
CONCLUSIONS: Patients potentially eligible for RELAX-AHF represent ≈2 in 10 patients with AHF in the United States, Latin America, or Asia-Pacific. These patients differ significantly from other hospitalized patients based on clinical characteristics and outcomes.

Entities:  

Keywords:  relaxin

Mesh:

Substances:

Year:  2014        PMID: 24594552     DOI: 10.1161/CIRCOUTCOMES.113.000418

Source DB:  PubMed          Journal:  Circ Cardiovasc Qual Outcomes        ISSN: 1941-7713


  12 in total

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

Authors:  Òscar Miró; Víctor Gil; Christian Müller; Alexander Mebazaa; Héctor Bueno; Francisco Javier Martín-Sánchez; Pablo Herrero; Javier Jacob; Pere Llorens
Journal:  Clin Res Cardiol       Date:  2015-04-24       Impact factor: 5.460

2.  Association of antidiabetic medications targeting the glucagon-like peptide 1 pathway and heart failure events in patients with diabetes.

Authors:  Mauricio Velez; Edward L Peterson; Karen Wells; Tanmay Swadia; Hani N Sabbah; L Keoki Williams; David E Lanfear
Journal:  J Card Fail       Date:  2014-10-28       Impact factor: 5.712

3.  Correlating eligibility criteria generalizability and adverse events using Big Data for patients and clinical trials.

Authors:  Anando Sen; Patrick B Ryan; Andrew Goldstein; Shreya Chakrabarti; Shuang Wang; Eileen Koski; Chunhua Weng
Journal:  Ann N Y Acad Sci       Date:  2016-09-06       Impact factor: 5.691

Review 4.  Blood Pressure Reduction in Hypertensive Acute Heart Failure.

Authors:  Nicholas Harrison; Peter Pang; Sean Collins; Phillip Levy
Journal:  Curr Hypertens Rep       Date:  2021-02-20       Impact factor: 5.369

5.  GIST 2.0: A scalable multi-trait metric for quantifying population representativeness of individual clinical studies.

Authors:  Anando Sen; Shreya Chakrabarti; Andrew Goldstein; Shuang Wang; Patrick B Ryan; Chunhua Weng
Journal:  J Biomed Inform       Date:  2016-09-04       Impact factor: 6.317

Review 6.  Emerging role of serelaxin in the therapeutic armamentarium for heart failure.

Authors:  Brandon C Varr; Mathew S Maurer
Journal:  Curr Atheroscler Rep       Date:  2014-10       Impact factor: 5.113

7.  Representativeness of a Heart Failure Trial by Race and Sex: Results From ASCEND-HF and GWTG-HF.

Authors:  Stephen J Greene; Adam D DeVore; Shubin Sheng; Gregg C Fonarow; Javed Butler; Robert M Califf; Adrian F Hernandez; Roland A Matsouaka; Ayman Samman Tahhan; Kevin L Thomas; Muthiah Vaduganathan; Clyde W Yancy; Eric D Peterson; Christopher M O'Connor; Robert J Mentz
Journal:  JACC Heart Fail       Date:  2019-10-09       Impact factor: 12.035

8.  Acute heart failure facts and numbers: acute heart failure populations.

Authors:  Julia Searle; Johann Frick; Martin Möckel
Journal:  ESC Heart Fail       Date:  2016-04-25

9.  Worse prognosis of real-world patients with acute heart failure from the Czech AHEAD registry in comparison to patients from the RELAX-AHF trial.

Authors:  Jindrich Spinar; Jiri Jarkovsky; Lenka Spinarova; Jiri Vitovec; Ales Linhart; Petr Widimsky; Roman Miklik; Kamil Zeman; Jan Belohlavek; Filip Malek; Cestmir Cihalik; Jiri Spac; Marian Felsoci; Petr Ostadal; Ladislav Dusek; Jiri Kettner; Jan Vaclavik; Simona Littnerova; Zdeněk Monhart; Josef Malek; Jiri Parenica
Journal:  ESC Heart Fail       Date:  2016-09-17

10.  Representativeness of the GALACTIC-HF Clinical Trial in Patients Having Heart Failure With Reduced Ejection Fraction.

Authors:  Matthew T Mefford; Sandra Y Koyama; Justine De Jesus; Rong Wei; Heidi Fischer; Teresa N Harrison; Pauline Woo; Kristi Reynolds
Journal:  J Am Heart Assoc       Date:  2022-03-24       Impact factor: 6.106

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