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Baseline characteristics of patients with heart failure and preserved ejection fraction in the PARAGON-HF Trial
Solomon, Scott Rizkala, Adel R. Lefkowitz, Martin P. Shi, Victor C. Gong, Jianjian Anavekar, Nagesh Anker, Stefan D. Arango, Juan Luis Arenas, Jose L. Atar, Dan
Solomon, Scott
Rizkala, Adel R.
Lefkowitz, Martin P.
Shi, Victor C.
Gong, Jianjian
Anavekar, Nagesh
Anker, Stefan D.
Arango, Juan Luis
Arenas, Jose L.
Atar, Dan
Author
Solomon, Scott
Rizkala, Adel R.
Lefkowitz, Martin P.
Shi, Victor C.
Gong, Jianjian
Anavekar, Nagesh
Anker, Stefan D.
Arango, Juan Luis
Arenas, Jose L.
Atar, Dan
Ben-Gal, Turia
Boytsov, Sergey
Chen, -Huan Chen
Chopra, Vijay
Cleland, John G. F.
Comin-Colet, Josep
Duengen, Hans-Dirk
Exheverria Correa, Luis E.
Filippatos, Gerasimos S.
Flammer, Andreas J.
Galinier, Michel
Godoy, Armando
Goncalvesova, Eva
Janssens, Stefan
Katova, Tzvetana
Køber, Lars
Lelonek, Małgorzata
Linssen, Gerard
Lund, Lars H.
O'Meara, Eileen
Merkely, Bela
Milicic, Davor
Oh, Byung-Hee
Perrone, Sergio V.
Ranjith, Naresh
Saito, Yoshihiko
Saraiva, Jose F.
Shah, Sanjiv J.
Seferovic, Peter M.
Senni, Michele
Sibulo
Sim, David
Sweitzer, Nancy K.
Taurio, Jyrki
Vinereanu, Dragos
Vrtovec, Bojan
Widimský
Yilmaz, Mehmet B.
Zhou, Jingmin
Zweiker, Robert
Anand, Inder S.
Ge, Junbo
Lam, Carolyn S. P.
Van Veldhuisen, Dirk J.
Zannad, Faiez
Zile, Michael R.
McMurray, John J. V.
Jr, Antonio S. Sibulo
Jr, Jiří Widimský
Rizkala, Adel R.
Lefkowitz, Martin P.
Shi, Victor C.
Gong, Jianjian
Anavekar, Nagesh
Anker, Stefan D.
Arango, Juan Luis
Arenas, Jose L.
Atar, Dan
Ben-Gal, Turia
Boytsov, Sergey
Chen, -Huan Chen
Chopra, Vijay
Cleland, John G. F.
Comin-Colet, Josep
Duengen, Hans-Dirk
Exheverria Correa, Luis E.
Filippatos, Gerasimos S.
Flammer, Andreas J.
Galinier, Michel
Godoy, Armando
Goncalvesova, Eva
Janssens, Stefan
Katova, Tzvetana
Køber, Lars
Lelonek, Małgorzata
Linssen, Gerard
Lund, Lars H.
O'Meara, Eileen
Merkely, Bela
Milicic, Davor
Oh, Byung-Hee
Perrone, Sergio V.
Ranjith, Naresh
Saito, Yoshihiko
Saraiva, Jose F.
Shah, Sanjiv J.
Seferovic, Peter M.
Senni, Michele
Sibulo
Sim, David
Sweitzer, Nancy K.
Taurio, Jyrki
Vinereanu, Dragos
Vrtovec, Bojan
Widimský
Yilmaz, Mehmet B.
Zhou, Jingmin
Zweiker, Robert
Anand, Inder S.
Ge, Junbo
Lam, Carolyn S. P.
Van Veldhuisen, Dirk J.
Zannad, Faiez
Zile, Michael R.
McMurray, John J. V.
Jr, Antonio S. Sibulo
Jr, Jiří Widimský
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.
Keywords
angiotensin receptor, antagonists, endopeptidases, heart failure, diastolic, clinical trial
Date
2018
Type
Journal article
Journal
Circulation: Heart Failure
Book
Volume
11
Issue
7
Page Range
1-10
Article Number
ACU Department
School of Theology
Faculty of Theology and Philosophy
Faculty of Theology and Philosophy
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Relation URI
Source URL
Event URL
Open Access Status
License
File Access
Controlled