TY - JOUR
T1 - Rationale, Design and Baseline Characteristics of the PARAGLIDE-HF Trial
T2 - Sacubitril/Valsartan vs Valsartan in HFmrEF and HFpEF With a Worsening Heart Failure Event
AU - MENTZ, ROBERT J.
AU - WARD, JONATHAN H.
AU - HERNANDEZ, ADRIAN F.
AU - LEPAGE, SERGE
AU - MORROW, DAVID A.
AU - SARWAT, SAMIHA
AU - SHARMA, KAVITA
AU - SOLOMON, SCOTT D.
AU - STARLING, RANDALL C.
AU - VELAZQUEZ, ERIC J.
AU - WILLIAMSON, KRISTIN
AU - ZIEROTH, SHELLEY
AU - BRAUNWALD, EUGENE
N1 - Funding Information:
PARAGLIDE-HF is funded by Novartis Pharmaceuticals Corporation. Clinical trial registration: clinicaltrials.gov identifier: NCT03988634.
Funding Information:
PARAGLIDE-HF is funded by Novartis Pharmaceuticals Corporation . Clinical trial registration: clinicaltrials.gov identifier: NCT03988634.
Publisher Copyright:
© 2023 The Authors
PY - 2023/6
Y1 - 2023/6
N2 - Background: The PARAGON-HF trial studied the effect of sacubitril/valsartan (Sac/Val) compared with valsartan (Val) on clinical outcomes in patients with chronic heart failure with preserved ejection fraction (HFpEF) or mildly reduced EF (HFmrEF). Further data are needed regarding the use of Sac/Val in these groups with EF and with recent worsening heart failure (WHF) events and in key populations not broadly represented in the PARAGON-HF trial, including those with de novo HF, the severely obese and Black patients. Methods: The PARAGLIDE-HF trial is a multicenter, double-blind, randomized, controlled trial of Sac/Val vs Val that enrolled patients at 100 sites. Medically stable patients ≥ 18 years old with EF > 40%, amino terminal-pro B-type natriuretic peptide (NT-proBNP) levels ≥ 500 pg/mL and within 30 days of a WHF event were eligible for participation. Patients were randomly assigned 1:1 to Sac/Val vs Val. The primary efficacy endpoint is time-averaged proportional change in NT-proBNP from baseline through Weeks 4 and 8. Secondary endpoints include clinical outcomes during follow-up and additional biomarker assessments. Safety endpoints include symptomatic hypotension, worsening renal function and hyperkalemia. Results: The trial enrolled 467 participants from June 2019 through October 2022 (52% women, 22% Black, age 70 ± 12 years, median (IQR) BMI 33 (27–40) kg/m2). The median (IQR) EF was 55% (50%–60%), 23% with HFmrEF (LVEF 41%–49%), 24% with EF > 60% and 33% with de novo HFpEF. Median screening NT-proBNP was 2009 (1291–3813) pg/mL, and 69% were enrolled in the hospital. Conclusions: The PARAGLIDE-HF trial enrolled a broad and diverse range of patients with heart failure with mildly reduced or preserved ejection fraction and will inform clinical practice by providing evidence about the safety, tolerability and efficacy of Sac/Val vs Val in those with a recent WHF event.
AB - Background: The PARAGON-HF trial studied the effect of sacubitril/valsartan (Sac/Val) compared with valsartan (Val) on clinical outcomes in patients with chronic heart failure with preserved ejection fraction (HFpEF) or mildly reduced EF (HFmrEF). Further data are needed regarding the use of Sac/Val in these groups with EF and with recent worsening heart failure (WHF) events and in key populations not broadly represented in the PARAGON-HF trial, including those with de novo HF, the severely obese and Black patients. Methods: The PARAGLIDE-HF trial is a multicenter, double-blind, randomized, controlled trial of Sac/Val vs Val that enrolled patients at 100 sites. Medically stable patients ≥ 18 years old with EF > 40%, amino terminal-pro B-type natriuretic peptide (NT-proBNP) levels ≥ 500 pg/mL and within 30 days of a WHF event were eligible for participation. Patients were randomly assigned 1:1 to Sac/Val vs Val. The primary efficacy endpoint is time-averaged proportional change in NT-proBNP from baseline through Weeks 4 and 8. Secondary endpoints include clinical outcomes during follow-up and additional biomarker assessments. Safety endpoints include symptomatic hypotension, worsening renal function and hyperkalemia. Results: The trial enrolled 467 participants from June 2019 through October 2022 (52% women, 22% Black, age 70 ± 12 years, median (IQR) BMI 33 (27–40) kg/m2). The median (IQR) EF was 55% (50%–60%), 23% with HFmrEF (LVEF 41%–49%), 24% with EF > 60% and 33% with de novo HFpEF. Median screening NT-proBNP was 2009 (1291–3813) pg/mL, and 69% were enrolled in the hospital. Conclusions: The PARAGLIDE-HF trial enrolled a broad and diverse range of patients with heart failure with mildly reduced or preserved ejection fraction and will inform clinical practice by providing evidence about the safety, tolerability and efficacy of Sac/Val vs Val in those with a recent WHF event.
KW - HFmrEF
KW - acute decompensated HFpEF
KW - clinical outcomes
KW - natriuretic peptides
KW - sacubitril/valsartan
UR - http://www.scopus.com/inward/record.url?scp=85150263509&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85150263509&partnerID=8YFLogxK
U2 - 10.1016/j.cardfail.2023.02.001
DO - 10.1016/j.cardfail.2023.02.001
M3 - Article
C2 - 36796671
AN - SCOPUS:85150263509
SN - 1071-9164
VL - 29
SP - 922
EP - 930
JO - Journal of cardiac failure
JF - Journal of cardiac failure
IS - 6
ER -