Baseline Characteristics of Patients With Heart Failure and Preserved Ejection Fraction in the PARAGON-HF Trial

et al.

doi:10.1161/circheartfailure.118.004962

Baseline Characteristics of Patients With Heart Failure and Preserved Ejection Fraction in the PARAGON-HF Trial

et al.

Department of Clinical Medicine

63 Citations (Scopus)

Abstract

BACKGROUND: To describe the baseline characteristics of patients with heart failure and preserved left ventricular ejection fraction enrolled in the PARAGON-HF trial (Prospective Comparison of Angiotensin Receptor Neprilysin Inhibitor With Angiotensin Receptor Blocker Global Outcomes in HFpEF) comparing sacubitril/valsartan to valsartan in reducing morbidity and mortality.

METHODS AND RESULTS: We report key demographic, clinical, and laboratory findings, and baseline therapies, of 4822 patients randomized in PARAGON-HF, grouped by factors that influence criteria for study inclusion. We further compared baseline characteristics of patients enrolled in PARAGON-HF with those patients enrolled in other recent trials of heart failure with preserved ejection fraction (HFpEF). Among patients enrolled from various regions (16% Asia-Pacific, 37% Central Europe, 7% Latin America, 12% North America, 28% Western Europe), the mean age of patients enrolled in PARAGON-HF was 72.7±8.4 years, 52% of patients were female, and mean left ventricular ejection fraction was 57.5%, similar to other trials of HFpEF. Most patients were in New York Heart Association class II, and 38% had ≥1 hospitalizations for heart failure within the previous 9 months. Diabetes mellitus (43%) and chronic kidney disease (47%) were more prevalent than in previous trials of HFpEF. Many patients were prescribed angiotensin-converting enzyme inhibitors or angiotensin receptor blockers (85%), β-blockers (80%), calcium channel blockers (36%), and mineralocorticoid receptor antagonists (24%). As specified in the protocol, virtually all patients were on diuretics, had elevated plasma concentrations of N-terminal pro-B-type natriuretic peptide (median, 911 pg/mL; interquartile range, 464-1610), and structural heart disease.

CONCLUSIONS: PARAGON-HF represents a contemporary group of patients with HFpEF with similar age and sex distribution compared with prior HFpEF trials but higher prevalence of comorbidities. These findings provide insights into the impact of inclusion criteria on, and regional variation in, HFpEF patient characteristics.

CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01920711.

Original language	English
Article number	e004962
Journal	Circulation. Heart failure
Volume	11
Issue number	7
Pages (from-to)	1-10
ISSN	1941-3289
DOIs	https://doi.org/10.1161/circheartfailure.118.004962
Publication status	Published - 1 Jul 2018

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10.1161/circheartfailure.118.004962

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title = "Baseline Characteristics of Patients With Heart Failure and Preserved Ejection Fraction in the PARAGON-HF Trial",

abstract = "BACKGROUND: To describe the baseline characteristics of patients with heart failure and preserved left ventricular ejection fraction enrolled in the PARAGON-HF trial (Prospective Comparison of Angiotensin Receptor Neprilysin Inhibitor With Angiotensin Receptor Blocker Global Outcomes in HFpEF) comparing sacubitril/valsartan to valsartan in reducing morbidity and mortality.METHODS AND RESULTS: We report key demographic, clinical, and laboratory findings, and baseline therapies, of 4822 patients randomized in PARAGON-HF, grouped by factors that influence criteria for study inclusion. We further compared baseline characteristics of patients enrolled in PARAGON-HF with those patients enrolled in other recent trials of heart failure with preserved ejection fraction (HFpEF). Among patients enrolled from various regions (16% Asia-Pacific, 37% Central Europe, 7% Latin America, 12% North America, 28% Western Europe), the mean age of patients enrolled in PARAGON-HF was 72.7±8.4 years, 52% of patients were female, and mean left ventricular ejection fraction was 57.5%, similar to other trials of HFpEF. Most patients were in New York Heart Association class II, and 38% had ≥1 hospitalizations for heart failure within the previous 9 months. Diabetes mellitus (43%) and chronic kidney disease (47%) were more prevalent than in previous trials of HFpEF. Many patients were prescribed angiotensin-converting enzyme inhibitors or angiotensin receptor blockers (85%), β-blockers (80%), calcium channel blockers (36%), and mineralocorticoid receptor antagonists (24%). As specified in the protocol, virtually all patients were on diuretics, had elevated plasma concentrations of N-terminal pro-B-type natriuretic peptide (median, 911 pg/mL; interquartile range, 464-1610), and structural heart disease.CONCLUSIONS: PARAGON-HF represents a contemporary group of patients with HFpEF with similar age and sex distribution compared with prior HFpEF trials but higher prevalence of comorbidities. These findings provide insights into the impact of inclusion criteria on, and regional variation in, HFpEF patient characteristics.CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01920711.",

author = "Solomon, {Scott D} and Rizkala, {Adel R} and Lefkowitz, {Martin P} and Shi, {Victor C} and JianJian Gong and Nagesh Anavekar and Anker, {Stefan D} and Arango, {Juan L} and Arenas, {Jose L} and Dan Atar and Turia Ben-Gal and Boytsov, {Sergey A} and Chen-Huan Chen and Chopra, {Vijay K} and John Cleland and Josep Comin-Colet and Hans-Dirk Duengen and {Echeverr{\'i}a Correa}, {Luis E} and Gerasimos Filippatos and Flammer, {Andreas J} and Michel Galinier and Armando Godoy and Eva Goncalvesova and Stefan Janssens and Tzvetana Katova and Lars K{\o}ber and Ma{\l}gorzata Lelonek and Gerard Linssen and Lund, {Lars H} and Eileen O'Meara and B{\'e}la Merkely and Davor Milicic and Byung-Hee Oh and Perrone, {Sergio V} and Naresh Ranjith and Yoshihiko Saito and Saraiva, {Jose F} and Sanjiv Shah and Seferovic, {Petar M} and Michele Senni and Sibulo, {Antonio S} and David Sim and Sweitzer, {Nancy K} and Jyrki Taurio and Dragos Vinereanu and Bojan Vrtovec and Ji{\v r}{\'i} Widimsk{\'y} and Yilmaz, {Mehmet B} and Jingmin Zhou and Robert Zweiker and {et al.}",

note = "{\textcopyright} 2018 American Heart Association, Inc.",

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doi = "10.1161/circheartfailure.118.004962",

language = "English",

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TY - JOUR

T1 - Baseline Characteristics of Patients With Heart Failure and Preserved Ejection Fraction in the PARAGON-HF Trial

AU - Solomon, Scott D

AU - Rizkala, Adel R

AU - Lefkowitz, Martin P

AU - Shi, Victor C

AU - Gong, JianJian

AU - Anavekar, Nagesh

AU - Anker, Stefan D

AU - Arango, Juan L

AU - Arenas, Jose L

AU - Atar, Dan

AU - Ben-Gal, Turia

AU - Boytsov, Sergey A

AU - Chen, Chen-Huan

AU - Chopra, Vijay K

AU - Cleland, John

AU - Comin-Colet, Josep

AU - Duengen, Hans-Dirk

AU - Echeverría Correa, Luis E

AU - Filippatos, Gerasimos

AU - Flammer, Andreas J

AU - Galinier, Michel

AU - Godoy, Armando

AU - Goncalvesova, Eva

AU - Janssens, Stefan

AU - Katova, Tzvetana

AU - Køber, Lars

AU - Lelonek, Małgorzata

AU - Linssen, Gerard

AU - Lund, Lars H

AU - O'Meara, Eileen

AU - Merkely, Béla

AU - Milicic, Davor

AU - Oh, Byung-Hee

AU - Perrone, Sergio V

AU - Ranjith, Naresh

AU - Saito, Yoshihiko

AU - Saraiva, Jose F

AU - Shah, Sanjiv

AU - Seferovic, Petar M

AU - Senni, Michele

AU - Sibulo, Antonio S

AU - Sim, David

AU - Sweitzer, Nancy K

AU - Taurio, Jyrki

AU - Vinereanu, Dragos

AU - Vrtovec, Bojan

AU - Widimský, Jiří

AU - Yilmaz, Mehmet B

AU - Zhou, Jingmin

AU - Zweiker, Robert

AU - et al.

PY - 2018/7/1

Y1 - 2018/7/1

N2 - BACKGROUND: To describe the baseline characteristics of patients with heart failure and preserved left ventricular ejection fraction enrolled in the PARAGON-HF trial (Prospective Comparison of Angiotensin Receptor Neprilysin Inhibitor With Angiotensin Receptor Blocker Global Outcomes in HFpEF) comparing sacubitril/valsartan to valsartan in reducing morbidity and mortality.METHODS AND RESULTS: We report key demographic, clinical, and laboratory findings, and baseline therapies, of 4822 patients randomized in PARAGON-HF, grouped by factors that influence criteria for study inclusion. We further compared baseline characteristics of patients enrolled in PARAGON-HF with those patients enrolled in other recent trials of heart failure with preserved ejection fraction (HFpEF). Among patients enrolled from various regions (16% Asia-Pacific, 37% Central Europe, 7% Latin America, 12% North America, 28% Western Europe), the mean age of patients enrolled in PARAGON-HF was 72.7±8.4 years, 52% of patients were female, and mean left ventricular ejection fraction was 57.5%, similar to other trials of HFpEF. Most patients were in New York Heart Association class II, and 38% had ≥1 hospitalizations for heart failure within the previous 9 months. Diabetes mellitus (43%) and chronic kidney disease (47%) were more prevalent than in previous trials of HFpEF. Many patients were prescribed angiotensin-converting enzyme inhibitors or angiotensin receptor blockers (85%), β-blockers (80%), calcium channel blockers (36%), and mineralocorticoid receptor antagonists (24%). As specified in the protocol, virtually all patients were on diuretics, had elevated plasma concentrations of N-terminal pro-B-type natriuretic peptide (median, 911 pg/mL; interquartile range, 464-1610), and structural heart disease.CONCLUSIONS: PARAGON-HF represents a contemporary group of patients with HFpEF with similar age and sex distribution compared with prior HFpEF trials but higher prevalence of comorbidities. These findings provide insights into the impact of inclusion criteria on, and regional variation in, HFpEF patient characteristics.CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01920711.

AB - BACKGROUND: To describe the baseline characteristics of patients with heart failure and preserved left ventricular ejection fraction enrolled in the PARAGON-HF trial (Prospective Comparison of Angiotensin Receptor Neprilysin Inhibitor With Angiotensin Receptor Blocker Global Outcomes in HFpEF) comparing sacubitril/valsartan to valsartan in reducing morbidity and mortality.METHODS AND RESULTS: We report key demographic, clinical, and laboratory findings, and baseline therapies, of 4822 patients randomized in PARAGON-HF, grouped by factors that influence criteria for study inclusion. We further compared baseline characteristics of patients enrolled in PARAGON-HF with those patients enrolled in other recent trials of heart failure with preserved ejection fraction (HFpEF). Among patients enrolled from various regions (16% Asia-Pacific, 37% Central Europe, 7% Latin America, 12% North America, 28% Western Europe), the mean age of patients enrolled in PARAGON-HF was 72.7±8.4 years, 52% of patients were female, and mean left ventricular ejection fraction was 57.5%, similar to other trials of HFpEF. Most patients were in New York Heart Association class II, and 38% had ≥1 hospitalizations for heart failure within the previous 9 months. Diabetes mellitus (43%) and chronic kidney disease (47%) were more prevalent than in previous trials of HFpEF. Many patients were prescribed angiotensin-converting enzyme inhibitors or angiotensin receptor blockers (85%), β-blockers (80%), calcium channel blockers (36%), and mineralocorticoid receptor antagonists (24%). As specified in the protocol, virtually all patients were on diuretics, had elevated plasma concentrations of N-terminal pro-B-type natriuretic peptide (median, 911 pg/mL; interquartile range, 464-1610), and structural heart disease.CONCLUSIONS: PARAGON-HF represents a contemporary group of patients with HFpEF with similar age and sex distribution compared with prior HFpEF trials but higher prevalence of comorbidities. These findings provide insights into the impact of inclusion criteria on, and regional variation in, HFpEF patient characteristics.CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01920711.

U2 - 10.1161/circheartfailure.118.004962

DO - 10.1161/circheartfailure.118.004962

M3 - Journal article

C2 - 29980595

SN - 1941-3289

VL - 11

SP - 1

EP - 10

JO - Circulation: Heart Failure

JF - Circulation: Heart Failure

IS - 7

M1 - e004962

ER -

Baseline Characteristics of Patients With Heart Failure and Preserved Ejection Fraction in the PARAGON-HF Trial

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