Phase
Condition
Congestive Heart Failure
Hyponatremia
Heart Failure
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- History of chronic HF (New York Heart Association [NYHA] Class II-IV) on standardtherapy before qualifying HF decompensation
- Previous HF hospitalization within 6 months prior to randomization or intravenous (IV)diuretic treatment for HF (without hospitalization) within 3 months.
- Brain natriuretic peptide (BNP) levels: sinus rhythm-≥ 300 pg/mL; atrialfibrillation-≥ 500 pg/mL and N-terminal pro-Brain Natriuretic Peptide (NT-proBNP)levels: sinus rhythm- ≥ 1000 pg/mL; atrial fibrillation - ≥ 1600 pg/mL within 30 daysprior to randomization
- Left ventricular ejection fraction (LVEF) of <45% assessed within 12 months prior torandomization by any method
- If female, is not of reproductive potential or agrees to avoid becoming pregnant whilereceiving study drug and for 14 days after the last dose of study drug by complyingwith one of the following: practice abstinence from heterosexual activity or use (orhave her partner use) acceptable contraception during heterosexual activity.
Exclusion
Exclusion Criteria:
- Clinically unstable at the time of randomization as defined by either theadministration of any IV treatment within 24 hours prior to randomization, and/orsystolic blood pressure (SBP) <100 mmHg or symptomatic hypotension
- Current or anticipated use of long-acting nitrates or nitric oxide (NO) donorsincluding isosorbide dinitrate, isosorbide 5-mononitrate, pentaerythritoltetranitrate, nicorandil or transdermal nitroglycerin (NTG) patch, and molsidomine
- Current or anticipated use of phosphodiesterase type 5 (PDE5) inhibitors such asvardenafil, tadalafil, and sildenafil
- Current use or anticipated use of a soluble guanylate cyclase (sGC) stimulator such asriociguat
- Known allergy or sensitivity to any sGC stimulator
- Awaiting heart transplantation (United Network for Organ Sharing Class 1A / 1B orequivalent), receiving continuous IV infusion of an inotrope, or has/anticipatesreceiving an implanted ventricular assist device
- Primary valvular heart disease requiring surgery or intervention, or is within 3months after valvular surgery or intervention
- Hypertrophic obstructive cardiomyopathy
- Acute myocarditis, amyloidosis, sarcoidosis, Takotsubo cardiomyopathy
- Post-heart transplant cardiomyopathy
- Tachycardia-induced cardiomyopathy and/or uncontrolled tachyarrhythmia
- Acute coronary syndrome (unstable angina, non-ST elevation myocardial infarction [NSTEMI], or ST elevation myocardial infarction [(STEMI]) or coronaryrevascularization (coronary artery bypass grafting [CABG] or percutaneous coronaryintervention [PCI]) within 60 days, or indication for coronary revascularization attime of randomization
- Symptomatic carotid stenosis, transient ischemic attack (TIA) or stroke within 60 days
- Complex congenital heart disease
- Active endocarditis or constrictive pericarditis
- Estimated glomerular filtration rate (eGFR) <15 mL/min/1.73 m2 or chronic dialysis
- Severe hepatic insufficiency such as with hepatic encephalopathy
- Malignancy or other non-cardiac condition limiting life expectancy to <3 years
- Require continuous home oxygen for severe pulmonary disease
- Current alcohol and/or drug abuse
- Participated in another interventional clinical study and treatment with anotherinvestigational product ≤30 days prior to randomization or plans to participate in anyother trial/investigation during the duration of this study
- Mental or legal incapacitation and is unable to provide informed consent
- Immediate family member (e.g., spouse, parent/legal guardian, sibling or child) who isinvolved with this study
- Interstitial Lung Disease
- Is pregnant or breastfeeding or plans to become pregnant or to breastfeed during thecourse of the study
Study Design
Connect with a study center
Merck Sharp & Dohme
Buenos Aires,
ArgentinaSite Not Available
Merck Sharp & Dohme
North Ryde,
AustraliaSite Not Available
MSD Osterreich GmbH
Vienna,
AustriaSite Not Available
MSD Belgium BVBA/SPRL
Brussels,
BelgiumSite Not Available
Merck Canada
Kirkland, Quebec H9H 3L1
CanadaSite Not Available
Merck Sharp & Dohme (I.A.) Corp.
Santiago,
ChileSite Not Available
Merck Sharp & Dohme (China) Ltd.
Beijing,
ChinaSite Not Available
MDS Colombia SAS
Bogota,
ColombiaSite Not Available
MSD SRO Czech
Prague, Prague 6
Czech RepublicSite Not Available
Merck Sharp & Dohme
Glostrup,
DenmarkSite Not Available
MSD Finland Oy
Espoo,
FinlandSite Not Available
MSD France
Paris,
FranceSite Not Available
MSD Sharp & Dohme GmbH
Haar,
GermanySite Not Available
Vianex, S.A. / MSD
Alimos,
GreeceSite Not Available
MSD CARD
Guatemala,
GuatemalaSite Not Available
Merck Sharp & Dohme (Asia) Ltd.
Hong Kong,
Hong KongSite Not Available
MSD Pharma Hungary Kft.
Budapest,
HungarySite Not Available
MSD Ireland (Human Health) Ltd.
Dublin,
IrelandSite Not Available
Merck Sharp & Dohme Co. Ltd.
Hod Hasharon,
IsraelSite Not Available
MSD Italia S.r.l.
Rome,
ItalySite Not Available
MSD K.K.
Chiyoda-Ku, Tokyo, 102-8667
JapanSite Not Available
MSD Korea LTD
Seoul, 4130
Korea, Republic ofSite Not Available
MSD
Petaling Jaya,
MalaysiaSite Not Available
MSD
Mexico City,
MexicoSite Not Available
Merck Sharp & Dohme BV
Haarlem,
NetherlandsSite Not Available
Merck Sharp & Dohme (New Zealand) Ltd.,
Wellington,
New ZealandSite Not Available
MSD Norge A/S
Drammen,
NorwaySite Not Available
Merck Sharp & Dohme, Peru S.R.L.
Lima,
PeruSite Not Available
Merck Sharp & Dohme (I.A.) Corporation
Makati,
PhilippinesSite Not Available
MSD Polska Sp. Z o.o.
Warsaw,
PolandSite Not Available
Call for Information (Investigational Site 1710)
Bayamon, 00960
Puerto RicoSite Not Available
Call for Information (Investigational Site 1706)
Caguas, 00725
Puerto RicoSite Not Available
Call for Information (Investigational Site 1707)
Humacao, 00791
Puerto RicoSite Not Available
Call for Information (Investigational Site 1702)
Mayaguez, 00680
Puerto RicoSite Not Available
Call for Information (Investigational Site 1701)
Ponce, 00717-1322
Puerto RicoSite Not Available
Call for Information (Investigational Site 1704)
San Juan, 00909-1711
Puerto RicoSite Not Available
Merck Sharp & Dohme IDEA, Inc.
Moscow,
Russian FederationSite Not Available
Merck Sharp & Dohme (I.A.) Corp
Singapore,
SingaporeSite Not Available
MSD (Pty) LTD South Africa
Midrand,
South AfricaSite Not Available
Merck Sharp and Dohme de Espana S.A.
Madrid,
SpainSite Not Available
MSD Sweden
Stockholm,
SwedenSite Not Available
MSD International GmbH
Lucerne 6,
SwitzerlandSite Not Available
Merck Sharp & Dohme (I.A.) Corp.
Taipei,
TaiwanSite Not Available
Merck Sharp & Dohme Ilaclari Ltd. Sti
Istanbul,
TurkeySite Not Available
MSD Ukraine LLC
Kiev,
UkraineSite Not Available
Merck Sharp & Dohme Ltd.
Hoddesdon,
United KingdomSite Not Available
Call for Information (Investigational Site 2893)
Alexander City, Alabama 35010
United StatesSite Not Available
Call for Information (Investigational Site 2405)
Mobile, Alabama 36608
United StatesSite Not Available
Call for Information (Investigational Site 2599)
Anchorage, Alaska 99508
United StatesSite Not Available
Call for Information (Investigational Site 2897)
Cottonwood, Arizona 86326
United StatesSite Not Available
Call for Information (Investigational Site 2731)
Gilbert, Arizona 85297
United StatesSite Not Available
Call for Information (Investigational Site 2539)
Tucson, Arizona 85724
United StatesSite Not Available
Call for Information (Investigational Site 2517)
Little Rock, Arkansas 72211
United StatesSite Not Available
Call for Information (Investigational Site 2498)
El Cajon, California 92020
United StatesSite Not Available
Call for Information (Investigational Site 2887)
Mather, California 95655
United StatesSite Not Available
Call for Information (Investigational Site 2750)
National City, California 91950
United StatesSite Not Available
Call for Information (Investigational Site 2903)
Orange, California 92868
United StatesSite Not Available
Call for Information (Investigational Site 2470)
Sacramento, California 95816
United StatesSite Not Available
Call for Information (Investigational Site 2889)
San Diego, California 92161
United StatesSite Not Available
Call for Information (Investigational Site 2479)
Torrance, California 90509
United StatesSite Not Available
Call for Information (Investigational Site 2771)
Colorado Springs, Colorado 80909
United StatesSite Not Available
Call for Information (Investigational Site 2497)
Littleton, Colorado 80120
United StatesSite Not Available
Call for Information (Investigational Site 2569)
Loveland, Colorado 80538
United StatesSite Not Available
Call for Information (Investigational Site 2544)
Hamden, Connecticut 06517
United StatesSite Not Available
Call for Information (Investigational Site 2473)
Wilmington, Delaware 19803
United StatesSite Not Available
Call for Information (Investigational Site 2543)
Washington, D.C., District of Columbia 20422
United StatesSite Not Available
Call for Information (Investigational Site 2886)
Clearwater, Florida 33756
United StatesSite Not Available
Call for Information (Investigational Site 2745)
Doral, Florida 33166
United StatesSite Not Available
Call for Information (Investigational Site 2435)
Fort Lauderdale, Florida 33308
United StatesSite Not Available
Call for Information (Investigational Site 2746)
Hialeah, Florida 33012
United StatesSite Not Available
Call for Information (Investigational Site 2589)
Hollywood, Florida 33021
United StatesSite Not Available
Call for Information (Investigational Site 2744)
Homestead, Florida 33030
United StatesSite Not Available
Call for Information (Investigational Site 2550)
Jacksonville, Florida 32209
United StatesSite Not Available
Call for Information (Investigational Site 2528)
Largo, Florida 33777
United StatesSite Not Available
Call for Information (Investigational Site 2739)
Miami, Florida 33175
United StatesSite Not Available
Call for Information (Investigational Site 2467)
Pembroke Pines, Florida 33026
United StatesSite Not Available
Call for Information (Investigational Site 2908)
Safety Harbor, Florida 34695
United StatesSite Not Available
Call for Information (Investigational Site 2422)
Saint Augustine, Florida 32086
United StatesSite Not Available
Call for Information (Investigational Site 2422)
St. Augustine, Florida 32086
United StatesSite Not Available
Call for Information (Investigational Site 2909)
Tampa, Florida 33614
United StatesSite Not Available
Call for Information (Investigational Site 2557)
Atlanta, Georgia 30309
United StatesSite Not Available
Call for Information (Investigational Site 2759)
Columbus, Georgia 31904
United StatesSite Not Available
Call for Information (Investigational Site 2898)
Covington, Georgia 30014
United StatesSite Not Available
Call for Information (Investigational Site 2730)
Fayetteville, Georgia 30214
United StatesSite Not Available
Call for Information (Investigational Site 2429)
Gainesville, Georgia 30501
United StatesSite Not Available
Call for Information (Investigational Site 2727)
Thomasville, Georgia 31792
United StatesSite Not Available
Call for Information (Investigational Site 2535)
Coeur d'Alene, Idaho 83814
United StatesSite Not Available
Call for Information (Investigational Site 2884)
Arlington Heights, Illinois 60005
United StatesSite Not Available
Call for Information (Investigational Site 2737)
Chicago, Illinois 60608
United StatesSite Not Available
Call for Information (Investigational Site 2591)
Maywood, Illinois 60153
United StatesSite Not Available
Call for Information (Investigational Site 2901)
Naperville, Illinois 60540
United StatesSite Not Available
Call for Information (Investigational Site 2414)
Peoria, Illinois 61614
United StatesSite Not Available
Call for Information (Investigational Site 2431)
Anderson, Indiana 46011
United StatesSite Not Available
Call for Information (Investigational Site 2769)
Indianapolis, Indiana 46237
United StatesSite Not Available
Call for Information (Investigational Site 2740)
Merrillville, Indiana 46410
United StatesSite Not Available
Call for Information (Investigational Site 2424)
Muncie, Indiana 47303
United StatesSite Not Available
Call for Information (Investigational Site 2752)
Munster, Indiana 46321
United StatesSite Not Available
Call for Information (Investigational Site 2437)
Iowa City, Iowa 52242
United StatesSite Not Available
Call for Information (Investigational Site 2885)
Elizabethtown, Kentucky 42701
United StatesSite Not Available
Call for Information (Investigational Site 2436)
Louisville, Kentucky 40205
United StatesSite Not Available
Call for Information (Investigational Site 2481)
Alexandria, Louisiana 71301
United StatesSite Not Available
Call for Information (Investigational Site 2407)
Hammond, Louisiana 70403
United StatesSite Not Available
Call for Information (Investigational Site 2765)
Houma, Louisiana 70360
United StatesSite Not Available
Call for Information (Investigational Site 2767)
Lafayette, Louisiana 70503
United StatesSite Not Available
Call for Information (Investigational Site 2445)
Monroe, Louisiana 71201
United StatesSite Not Available
Call for Information (Investigational Site 2507)
New Orleans, Louisiana 70121
United StatesSite Not Available
Call for Information (Investigational Site 2766)
Opelousas, Louisiana 70570
United StatesSite Not Available
Call for Information (Investigational Site 2430)
Slidell, Louisiana 70458
United StatesSite Not Available
Call for Information (Investigational Site 2490)
Scarborough, Maine 04074
United StatesSite Not Available
Call for Information (Investigational Site 2888)
Baltimore, Maryland 21229
United StatesSite Not Available
Call for Information (Investigational Site 2488)
Boston, Massachusetts 02114
United StatesSite Not Available
Call for Information (Investigational Site 2763)
Detroit, Michigan 48201
United StatesSite Not Available
Call for Information (Investigational Site 2556)
Grand Blanc, Michigan 48439
United StatesSite Not Available
Call for Information (Investigational Site 2593)
Kalamazoo, Michigan 49048
United StatesSite Not Available
Call for Information (Investigational Site 2595)
Lansing, Michigan 48912
United StatesSite Not Available
Call for Information (Investigational Site 2883)
Petoskey, Michigan 49770
United StatesSite Not Available
Call for Information (Investigational Site 2736)
Saginaw, Michigan 48602
United StatesSite Not Available
Call for Information (Investigational Site 2592)
Southfield, Michigan 48075
United StatesSite Not Available
Call for Information (Investigational Site 2448)
Saint Cloud, Minnesota 56303
United StatesSite Not Available
Call for Information (Investigational Site 2404)
Saint Paul, Minnesota 55102
United StatesSite Not Available
Call for Information (Investigational Site 2448)
St. Cloud, Minnesota 56303
United StatesSite Not Available
Call for Information (Investigational Site 2484)
Kansas City, Missouri 64111
United StatesSite Not Available
Call for Information (Investigational Site 2476)
Saint Louis, Missouri 63110
United StatesSite Not Available
Call for Information (Investigational Site 2877)
Springfield, Missouri 65804
United StatesSite Not Available
Call for Information (Investigational Site 2552)
St. Louis, Missouri 63136
United StatesSite Not Available
Call for Information (Investigational Site 2773)
Washington, Missouri 63090
United StatesSite Not Available
Call for Information (Investigational Site 2760)
Kalispell, Montana 59901
United StatesSite Not Available
Call for Information (Investigational Site 2532)
Lincoln, Nebraska 68526
United StatesSite Not Available
Call for Information (Investigational Site 2526)
Omaha, Nebraska 68124
United StatesSite Not Available
Call for Information (Investigational Site 2433)
Las Vegas, Nevada 89128
United StatesSite Not Available
Call for Information (Investigational Site 2439)
Bridgewater, New Jersey 08807-3060
United StatesSite Not Available
Call for Information (Investigational Site 2421)
Elmer, New Jersey 08318
United StatesSite Not Available
Call for Information (Investigational Site 2896)
Flemington, New Jersey 08822
United StatesSite Not Available
Call for Information (Investigational Site 2489)
Haddon Heights, New Jersey 08035
United StatesSite Not Available
Call for Information (Investigational Site 2738)
Ridgewood, New Jersey 07450
United StatesSite Not Available
Call for Information (Investigational Site 2469)
Sewell, New Jersey 08080
United StatesSite Not Available
Call for Information (Investigational Site 2554)
Somerset, New Jersey 08873
United StatesSite Not Available
Call for Information (Investigational Site 2450)
Voorhees, New Jersey 08043
United StatesSite Not Available
Call for Information (Investigational Site 2726)
Albuquerque, New Mexico 87102
United StatesSite Not Available
Call for Information (Investigational Site 2756)
Bronx, New York 10455
United StatesSite Not Available
Call for Information (Investigational Site 2581)
Cheektowaga, New York 14227
United StatesSite Not Available
Call for Information (Investigational Site 2910)
New York, New York 10010
United StatesSite Not Available
Call for Information (Investigational Site 2742)
Saratoga Springs, New York 12866
United StatesSite Not Available
Call for Information (Investigational Site 2503)
Stony Brook, New York 11794
United StatesSite Not Available
Call for Information (Investigational Site 2538)
The Bronx, New York 10461
United StatesSite Not Available
Call for Information (Investigational Site 2501)
Chapel Hill, North Carolina 27599
United StatesSite Not Available
Call for Information (Investigational Site 2501)
Chapel Hills, North Carolina 27599
United StatesSite Not Available
Call for Information (Investigational Site 2500)
Charlotte, North Carolina 28204
United StatesSite Not Available
Call for Information (Investigational Site 2485)
Greensboro, North Carolina 27401
United StatesSite Not Available
Call for Information (Investigational Site 2528)
Research Triangle Park, North Carolina 27713
United StatesSite Not Available
Call for Information (Investigational Site 2452)
Canton, Ohio 44710
United StatesSite Not Available
Call for Information (Investigational Site 2762)
Cincinnati, Ohio 45219
United StatesSite Not Available
Call for Information (Investigational Site 2600)
Toledo, Ohio 43606
United StatesSite Not Available
Call for Information (Investigational Site 2585)
Oklahoma City, Oklahoma 73112
United StatesSite Not Available
Call for Information (Investigational Site 2907)
Abington, Pennsylvania 19001
United StatesSite Not Available
Call for Information (Investigational Site 2733)
Doylestown, Pennsylvania 18901
United StatesSite Not Available
Call for Information (Investigational Site 2573)
Hershey, Pennsylvania 17033
United StatesSite Not Available
Call for Information (Investigational Site 2751)
Philadelphia, Pennsylvania 19140
United StatesSite Not Available
Call for Information (Investigational Site 2570)
Pittsburgh, Pennsylvania 15213
United StatesSite Not Available
Call for Information (Investigational Site 2747)
Providence, Rhode Island 02903
United StatesSite Not Available
Call for Information (Investigational Site 2456)
Charleston, South Carolina 29407
United StatesSite Not Available
Call for Information (Investigational Site 2474)
Greenville, South Carolina 29607
United StatesSite Not Available
Call for Information (Investigational Site 2906)
Germantown, Tennessee 38138
United StatesSite Not Available
Call for Information (Investigational Site 2770)
Jackson, Tennessee 38301
United StatesSite Not Available
Call for Information (Investigational Site 2904)
Knoxville, Tennessee 37917
United StatesSite Not Available
Call for Information (Investigational Site 2876)
Nashville, Tennessee 37212
United StatesSite Not Available
Call for Information (Investigational Site 2904)
Powell, Tennessee 37849
United StatesSite Not Available
Call for Information (Investigational Site 2575)
Tullahoma, Tennessee 37388
United StatesSite Not Available
Call for Information (Investigational Site 2413)
Amarillo, Texas 79106
United StatesSite Not Available
Call for Information (Investigational Site 2749)
Dallas, Texas 75216
United StatesSite Not Available
Call for Information (Investigational Site 2584)
Houston, Texas 77030
United StatesSite Not Available
Call for Information (Investigational Site 2516)
Kerrville, Texas 78028
United StatesSite Not Available
Call for Information (Investigational Site 2772)
Lufkin, Texas 75904
United StatesSite Not Available
Call for Information (Investigational Site 2508)
San Antonio, Texas 78201
United StatesSite Not Available
Call for Information (Investigational Site 2403)
Tomball, Texas 77375-4536
United StatesSite Not Available
Call for Information (Investigational Site 2551)
Tyler, Texas 75708
United StatesSite Not Available
Call for Information (Investigational Site 2566)
Salt Lake City, Utah 84132-2101
United StatesSite Not Available
Call for Information (Investigational Site 2586)
Falls Church, Virginia 22042
United StatesSite Not Available
Call for Information (Investigational Site 2587)
Manassass, Virginia 20109
United StatesSite Not Available
Call for Information (Investigational Site 2571)
Norfolk, Virginia 23507
United StatesSite Not Available
Call for Information (Investigational Site 2563)
Richmond, Virginia 23225
United StatesSite Not Available
Call for Information (Investigational Site 2435)
Puyallup, Washington 98374-2115
United StatesSite Not Available
Call for Information (Investigational Site 2899)
Madison, Wisconsin 53705
United StatesSite Not Available
Call for Information (Investigational Site 2492)
Milwaukee, Wisconsin 53215
United StatesSite Not Available
Call for Information (Investigational Site 2482)
Wausau, Wisconsin 54401
United StatesSite Not Available
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