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 (US) |
|---|---|
| Article number | e004962 |
| Journal | Circulation: Heart Failure |
| Volume | 11 |
| Issue number | 7 |
| DOIs | |
| State | Published - Jul 1 2018 |
Keywords
- angiotensin receptor antagonists
- clinical trial
- endopeptidases
- heart failure, diastolic
ASJC Scopus subject areas
- Cardiology and Cardiovascular Medicine
Access to Document
Other files and links
Fingerprint
Dive into the research topics of 'Baseline characteristics of patients with heart failure and preserved ejection fraction in the PARAGON-HF trial'. Together they form a unique fingerprint.Cite this
- APA
- Standard
- Harvard
- Vancouver
- Author
- BIBTEX
- RIS
Baseline characteristics of patients with heart failure and preserved ejection fraction in the PARAGON-HF trial. / Solomon, Scott D.; Rizkala, Adel R.; Lefkowitz, Martin P.; Shi, Victor C.; Gong, Jianjian; Anavekar, Nagesh; Anker, Stefan D.; Arango, Juan L.; Arenas, Jose L.; Atar, Dan; Ben-Gal, Turia; Boytsov, Sergey A.; Chen, Chen Huan; Chopra, Vijay K.; Cleland, John; Comin-Colet, Josep; Duengen, Hans Dirk; Echeverría Correa, Luis E.; Filippatos, Gerasimos; 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, Béla; Milicic, Davor; Oh, Byung Hee; Perrone, Sergio V.; Ranjith, Naresh; Saito, Yoshihiko; Saraiva, Jose F.; Shah, Sanjiv; Seferovic, Petar M.; Senni, Michele; Sibulo, Antonio S.; Sim, David; Sweitzer, Nancy K.; Taurio, Jyrki; Vinereanu, Dragos; Vrtovec, Bojan; Widimský, Jiří; Yilmaz, Mehmet B.; Zhou, Jingmin; Zweiker, Robert; Anand, Inder S.; Ge, Junbo; Lam, Carolyn S.P.; Maggioni, Aldo P.; Martinez, Felipe; Packer, Milton; Pfeffer, Marc A.; Pieske, Burkert; Redfield, Margaret M.; Rouleau, Jean L.; Van Veldhuisen, Dirk J.; Zannad, Faiez; Zile, Michael R.; McMurray, John J.V.
In: Circulation: Heart Failure, Vol. 11, No. 7, e004962, 01.07.2018.Research output: Contribution to journal › Article › peer-review
}
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 - Anand, Inder S.
AU - Ge, Junbo
AU - Lam, Carolyn S.P.
AU - Maggioni, Aldo P.
AU - Martinez, Felipe
AU - Packer, Milton
AU - Pfeffer, Marc A.
AU - Pieske, Burkert
AU - Redfield, Margaret M.
AU - Rouleau, Jean L.
AU - Van Veldhuisen, Dirk J.
AU - Zannad, Faiez
AU - Zile, Michael R.
AU - McMurray, John J.V.
N1 - Funding Information: Drs Solomon, Anavekar, Boytsov, Duengen, Galinier, Lelonek, Lund, Shah, and Vinereanu have received research grants from Novartis and have consulted for Novartis. Dr Anker reports personal fees from Bayer, Boehringer Ingelheim, Vi-for, V-Wave, Impulse Dynamics, Novartis, Servier, and Stealth Peptides all for registry and clinical trial related committee work and lecture fees. Dr Anker also reports having received research grants for investigator-initiated trials from Vi-for and Abbott Vascular. Dr Arango has received funds for clinical studies and has consulted for Novartis. Dr Arenas reports investigator fees from Novartis, MSD, Amgen, Sanofi, Takeda, Janssen and Novo Nordisk paid to his institution and reports speaker fees from MSD and Novartis. Dr Atar has received speaker or consultancy fees from Novartis, MSD, AstraZeneca, Bayer, Pfizer/BMS and Boehringer Ingelheim. Dr Chen has consulted for Novartis and is on the speakers’ bureau of Novartis. Dr Cleland has received research grants from Amgen, Bayer, Medtronic, Novartis, and Stealth Biopharmaceuticals, has consulted and lectured for Amgen, Bayer, Medtronic, Novartis, Philips, Stealth Biopharmaceu-ticals, and Vifor. Dr Comin-Colet has received unrestricted research grants and consultancy honoraria from Novartis. Dr Echeverria has received lecture and consultancy fees from Novartis. Dr Filippatos reports honoraria as committee member of trials sponsored by Novartis during the conduct of the study and honoraria as committee member of trials or registries sponsored by Bayer, Servier, Medtronic, outside the submitted work. Dr Flammer has received research support, consultancy fees and speaker honoraria from Novartis. Dr Godoy has received lecture fees from Pfizer, Sanofi, Menarini, and Tecnofarma and fees for serving as principal investigator for Novartis, AstraZeneca and Merck. Dr Jans-sens has received research grants from Novartis and has a consultancy agreement with Novartis through the University of Leuven, Belgium. Dr Katova has received speaker fees from Novartis, Servier, Astra Zeneca, Egis, Berlin Chemie, and Pfizer. Dr Saraiva reports consulting fees and grant support from Amgen, Novo Nordisk, Eli Lilly, AstraZeneca, Novartis, Sanofi-Aventis, Boehringer Ingel-heim. Dr Koeber has received speaker honoraria from Novartis and Astra Zeneca. Dr O’Meara has served as a consultant for Amgen, Bayer, Novartis and Servier, and as a speaker for AstraZeneca, Bayer, Novartis, Pfizer/Bristol-Myers Squibb and Servier. Dr O’Meara’s institution, the Montreal Heart Institute, has received payments for her participation in clinical trials by Novartis, Bayer, AstraZeneca, Cardiorentis, Merck, Servier, and Amgen. Dr Merkely has received speaker fees and consultancy fees from Sanofi-Aventis, Medtronic, Abbott, and Biotronik. Dr Milicic has lectured and consulted for Novartis. Dr Perrone has received fees from Novartis for conferences, clinical research programs and to integrate an advisory group. Dr Ranjith has consulted for Novartis and Bayer. Dr Sim has received honorarium from Novartis. Dr Sweitzer has received research grants from Novartis and Merck. Dr Vrtovec reports investigator fees paid to his institution. Dr Yilmaz has received institutional research grants from Novartis, Bayer, Amgen and has consulted Novartis, Bayer, Amgen via institutional contracts. Dr Anand has received consulting fees from Amgen, ARCA Biopharma, AstraZen-eca, Boehringer Ingelheim, LivaNova, Novartis, and Zensun. Dr Ge has received honoraria from Novartis. Dr Lam has received consulting fees from Novartis, Bayer, Takeda, Merck, AstraZeneca, Janssen Research & Development, LLC, Me-narini, Boehringer Ingelheim, and Abbott Diagnostics; research support from Bayer, Boston Scientific, Thermofisher, Medtronic, and Vifor Pharma; and is supported by a Clinical Scientist Award from the National Medical Research Council Singapore. Dr Maggioni is a member of the executive/steering committees of Novartis, Bayer, and Cardiorentis. Dr Martinez is a member of the PARAGON-HF steering committee and has consulted for Novartis and Astra Zeneca. Dr Packer has received personal fees from Akcea, AstraZeneca, Amgen, Bayer, Boehringer Ingelheim, Cardiorentis, Celyad, Daiichi Sankyo, Gilead, Novo Nordisk, Pfizer, Relypsa, Sanofi, Takeda, and ZS Pharma. Dr Pfeffer has received grant support from Novartis and Sanofi; consulting fees from AstraZeneca, Bayer, Boehringer Ingelheim, DalCor, Genzyme, Gilead, GlaxoSmithKline, Janssen, Lilly, Medicines Company, Merck, Novartis, Novo Nordisk, Relypsa, Sanofi, Teva, and Thrasos; owns stock options for DalCor; and is listed on a patent awarded to Brigham and Women’s Hospital on the use of inhibitors of the renin-angiotensin system in myocardial infarction (licensed by Novartis, with Dr Pfeffer’s share irrevocably assigned to charity). Dr Pieske has relationships with Novartis, Bayer Healthcare, Stealth Peptides, Daiichi-Sankyo, Vifor, AstraZeneca, and Bristol-Myers Squibb; and is a consultant for Merck, Sharp, and Dohme. Dr Redfield has served as an unpaid consultant for Novartis. Dr Saito has received consultancy fees from Novartis and investigator fees from Novartis paid to his institution. Dr Veldhuisen has received board membership fees from Novartis. Dr Zannad has received consulting fees from Novartis. and has served as a steering committee member of the PARAGON-HF trial. Dr McMurray has served as an executive committee member and coprincipal investigator of ATMOSPHERE (Efficacy and Safety of Aliskiren and Aliskiren/Enalapril Combination on Morbidity-Mortality in Patients With Chronic Heart Failure) and coprincipal investigator of the PARADIGM-HF and PARAGON-HF trials; and his employer, Glasgow University, has been paid by Novartis for his time spent in these roles. Drs Chopra, Goncalvesova, Oh, Senni, Widimsky, Zile, and Zweiker have consulted for Novartis. Drs Ben-Gal, Seferovic, and Taurio have received lecture fees from Novartis. Drs Sibulo and Zhou have received research grants from Novartis. Drs Rizkala, Lefkowitz, Shi, and Gong are employees of Novartis. The other authors report no conflicts. Publisher Copyright: © 2018 American Heart Association, Inc.
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.
KW - angiotensin receptor antagonists
KW - clinical trial
KW - endopeptidases
KW - heart failure, diastolic
UR - http://www.scopus.com/inward/record.url?scp=85056774762&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85056774762&partnerID=8YFLogxK
U2 - 10.1161/CIRCHEARTFAILURE.118.004962
DO - 10.1161/CIRCHEARTFAILURE.118.004962
M3 - Article
C2 - 29980595
AN - SCOPUS:85056774762
VL - 11
JO - Circulation: Heart Failure
JF - Circulation: Heart Failure
SN - 1941-3297
IS - 7
M1 - e004962
ER -