Changes in NT-proBNP, Safety, and Tolerability in HFpEF Patients With a WHF Event (HFpEF Decompensation) Who Have Been Stabilized and Initiated at the Time of or Within 30 Days Post-decompensation (PARAGLIDE-HF)

PHASE3CompletedINTERVENTIONAL
Enrollment

467

Participants

Timeline

Start Date

June 29, 2019

Primary Completion Date

December 14, 2022

Study Completion Date

December 14, 2022

Conditions
Heart Failure With Preserved Ejection Fraction (HFpEF)
Interventions
DRUG

sacubitril/valsartan

Sacubitril/valsartan (LCZ696) was available as 24/26 mg, 49/51 mg, and 97/103 mg in tablet form to be taken orally, twice daily

DRUG

valsartan

Valsartan was available as 40 mg, 80 mg, and 160 mg in tablet form to be taken orally, twice daily

DRUG

sacubitril/valsartan matching placebo

Sacubitril/valsartan (LCZ696) matching placebo was available as tablet form to be taken orally, twice daily

DRUG

valsartan matching placebo

Valsartan matching placebo was available as tablet form to be taken orally, twice daily

Trial Locations (97)

10029

Mount Sinai Hospital ., New York

10310

Mount Sinai Health System, Staten Island

10461

Montefiore Medical Center ., The Bronx

11030

Northwell Health ., Manhasset

11355

New York Presbyterian Queens ., Flushing

11576

Catholic Hlth Svcs of Long Island, Roslyn

11794

Stony Brook University Medical Center CLCZ696G2301, Stony Brook

12205

Albany Associates In Cardiology, Albany

12601

HealthQuest, Poughkeepsie

13790

United Health Services Office Of Clinical Trails CLCZ696BUS01, Johnson

15065

Allegheny Valley Hospital ., Natrona Heights

17074

Capital Area Research LLC CACZ885M2301, Newport

19001

Jefferson Abington ., Abington

19107

Thomas Jefferson Univ Hospital ., Philadelphia

19713

Cardiology Physicians PA ., Newark

21287

Johns Hopkins Univ School of Med, Baltimore

21804

Tidal Health Peninsula Regional Inc ., Salisbury

24501

Centra Health, Lynchburg

27710

Duke Health, Durham

30310

Morehouse School Of Medicine, Atlanta

30322

Emory University School of Medicine/Winship Cancer Institute, Atlanta

30901

University Cardiology Associates, Augusta

32209

University of Florida Health Science Center, Jacksonville

32610

University of Florida Health ., Gainesville

33016

New Generation of Medical Research Avera Health N Central Heart, Hialeah

34239

Intercoastal Medical Group, Sarasota

37212

VA Tennessee Valley Healthcare System, Nashville

39216

Jackson Heart Clinic, Jackson

43608

St. Vincent Mercy Medical Center, Toledo

44195

Cleveland Clinic Foundation ., Cleveland

46202

Indiana University Health, Indianapolis

46237

Franciscan Health Services Research Center ., Indianapolis

46514

Midwest Cardiovascular Research and Education Foundation ., Elkhart

47303

Indiana University Health, Muncie

47374

Reid Hosp And Hlth Care Services, Richmond

48109

University of Michigan Hs, Ann Arbor

48197

Trinity Health Michigan Heart ., Ypsilanti

48201

Detroit Medical Center Cardiovascular Clinical Trial ., Detroit

48202

Henry Ford Hospital Cardiovascular Medicine, Detroit

55101

Novartis Investigative Site, Saint Paul

57105

North Central Heart ., Sioux Falls

57701

Regional Health Clinic Research ., Rapid City

60007

Amita Health, Elk Grove Village

60068

Advocate Medical Group ., Park Ridge

60181

Midwest Cardiovascular Institute ., Oakbrook Terrace

60190

Northwestern Medicine Northwestern University, Winfield

60637

University of Chicago ., Chicago

61606

Unity Point Health Methodist, Peoria

61614

OSF HealthCare, Peoria

66160

The Uni of Kansas Medical Center, Kansas City

68198

University of Nebraska Medical Center, Omaha

68510

Nebraska Heart Institute CHI Health Nebraska, Lincoln

70808

The Franciscan Missionaries, Baton Rouge

71301

Alexandria Cardiology Clinic, Alexandria

74006

St John Health System, Bartlesville

74104

Regional Medical Labaratory, Tulsa

75246

Baylor University Medical Center ., Dallas

79106

Pharma Tex Research ., Amarillo

80120

South Denver Cardiology Associates PC, Littleton

80228

Colorado Heart and Vascular ., Lakewood

80923

St Francis Medical Center, Colorado Springs

83702

St Lukes Idaho Cardiology Associates CLCZ696BUS13, Boise

87106

Cedar Multi-Specialty Clinic, Albuquerque

89201

Univ Medical Center Las Vegas, Las Vegas

89502

R Ins For Heart And Vascular Health, Reno

90806

Memorial Care Health System Memorialcare Long Beach, Long Beach

92123

San Diego Cardiac Center, San Diego

92660

University of Calif Irvine Med Cntr, Irvine

92704

Helping Hands Medical Associates INC, Santa Ana

94110

Zuckerberg General W84 Research ., San Francisco

94806

Sutter Health Network ., San Pablo

98122

Swedish Medical Ctr Cardiovascular Re, Seattle

90033-4605

University Of Southern California ., Los Angeles

University Of Southern California, Los Angeles

06109

Hartford Healthcare Headache Center, West Hartford

06516

VA Connecticut Healthcare System, West Haven

04401

Northern Light Easter Maine Medical Center ., Bangor

02114

Massachusetts General Hospital, Boston

02118

Boston Univeristy Medical Center ., Boston

02215

Beth Israel Deaconess Med Ctr CLCZ696D2301, Boston

08318

Inspira Health Network, Elmer

08035

Cooper University Health Care, Haddon Heights

07102

Saint Michael Medical Center, Newark

27599-7075

University Of North Carolina At Chapel Hill CRLX030A2209, Chapel Hill

77555-1062

The University of Texas Medical Branch, Galveston

05401

The University of Vermont Medical Center CRLX030A2301, Burlington

53792-1615

University of Wisconsin School of Medicine and Public Health CLCZ696BUS01, Madison

V8R4R2

Novartis Investigative Site, Victoria

R2H 2A6

Novartis Investigative Site, Winnipeg

L8L 2X2

Novartis Investigative Site, Hamilton

H1T 1C8

Novartis Investigative Site, Montreal

H2X 0A9

Novartis Investigative Site, Montreal

H3G 1A4

Novartis Investigative Site, Montreal

G1R 2J6

Novartis Investigative Site, Québec

G7H 5H6

Novartis Investigative Site, Saguenay

J1H 5N4

Novartis Investigative Site, Sherbrooke

J6V 2H2

Novartis Investigative Site, Terrebonne

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY