Study Description
This is a multicenter, randomized, placebo- and active-controlled, parallel-group, 24-week trial to investigate the efficacy, safety, and tolerability of XXB750 in participants with HFrEF/HFmrEF.
Eligible participants will be randomized to receive either subcutaneous (s.c.) XXB750 or placebo; or sacubitril/valsartan for 16 weeks, and then followed-up for 8 weeks
Interventions
Placebo
Sacubitril/valsartan
XXB750 High Dose
XXB750 Low dose
XXB750 Medium Dose
Eligibility Criteria
Inclusion Criteria:
Current symptom(s) of HF NYHA class II-III and LVEF < 50%
Elevated NT-proBNP levels at screening.
Receiving standard of care background HF therapy.
Exclusion Criteria:
Current acute decompensated HF or hospitalization for HF within 3 months prior to screening.
Current symptomatic hypotension (for example dizziness/presyncope).
K+ > 5.4 mmol/L at screening
eGFR < 30 mL/min/1.73m2 at screening
Other protocol-specific criteria may apply.
Study Location
Novartis Investigative Site
Recruiting
Sofia,1510,Bulgaria
Novartis Investigative Site
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Gabrovo,5300,Bulgaria
Novartis Investigative Site
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Blagoevgrad,270 0,Bulgaria
Novartis Investigative Site
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Pleven,5800,Bulgaria
Novartis Investigative Site
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Sofia,1233,Bulgaria
Novartis Investigative Site
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Beziers Cedex,34525,France
Novartis Investigative Site
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Rouen,76031,France
Novartis Investigative Site
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Montpellier,34295,France
Novartis Investigative Site
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Frankfurt,60594,Germany
Novartis Investigative Site
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Kiel,24105,Germany
Novartis Investigative Site
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Gladbeck,45968,Germany
Novartis Investigative Site
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Schwaebisch Hall,74523,Germany
Novartis Investigative Site
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Essen,Nordrhein Westfalen,45355,Germany
Novartis Investigative Site
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Ludwigshafen,67067,Germany
Novartis Investigative Site
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Roma,RM,00161,Italy
Novartis Investigative Site
Recruiting
Messina,ME,98125,Italy
Novartis Investigative Site
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Trieste,TS,34149,Italy
Novartis Investigative Site
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Milano,MI,20138,Italy
Novartis Investigative Site
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Brescia,BS,25123,Italy
Novartis Investigative Site
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Cona,FE,44100,Italy
Novartis Investigative Site
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Pisa,PI,56126,Italy
Novartis Investigative Site
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Kawasaki-city,Kanagawa,216-8511,Japan
Novartis Investigative Site
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Matsumoto,Nagano,390-8621,Japan
Novartis Investigative Site
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Sagamihara,Kanagawa,252-0375,Japan
Novartis Investigative Site
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Koriyama,Fukushima,963-8501,Japan
Novartis Investigative Site
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Hachioji-city,Tokyo,192-0918,Japan
Novartis Investigative Site
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Maebashi city,Gunma,371 8511,Japan
Novartis Investigative Site
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Lisboa,1495 005,Portugal
Novartis Investigative Site
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Lisboa,1500 650,Portugal
Novartis Investigative Site
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Vila Nova De Gaia,4434 502,Portugal
Novartis Investigative Site
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Madrid,28034,Spain
Novartis Investigative Site
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Madrid,28040,Spain
Novartis Investigative Site
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Utrera,Andalucia,41710,Spain
Novartis Investigative Site
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Madrid,28041,Spain
Novartis Investigative Site
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Santiago De Compostela,Galicia,15706,Spain
Novartis Investigative Site
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Las Palmas de Gran Canaria,35010,Spain
Novartis Investigative Site
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Valencia,Comunidad Valenciana,46010,Spain
Novartis Investigative Site
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Madrid,28222,Spain
Novartis Investigative Site
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Huelva,Andalucia,21005,Spain
Novartis Investigative Site
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Sevilla,Andalucia,41014,Spain
Novartis Investigative Site
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El Palmar,Murcia,30120,Spain
Novartis Investigative Site
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Malaga,Andalucia,29010,Spain
Novartis Investigative Site
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Kaohsiung,80756,Taiwan
Nature Coast Clinical Research LLC
Recruiting
Inverness,Donald Bowen (352-341-2100) email: [email protected] -- Rafik Abadier,34452 - Florida,United States
Pima Heart And Vascular Clin Rch .
Recruiting
Tucson,Natheer Aljanabi (520-838-3540) email: [email protected] -- Ajay Tuli,85704 - Arizona,United States
Grace Research Llc .
Recruiting
Shreveport,Taylor Moore (318-626-5180) email: [email protected] -- Anil Chhabra,71101 - Louisiana,United States
Aultman Hospital
Recruiting
Canton,Ataul Qureshi,44710 - Ohio,United States
Universal Research Group LLC Suite 202
Recruiting
Tacoma,Iliana Mcdaniel (253-882-1070) email: [email protected] -- Sabrina Benjamin,98405 - Washington,United States
Revival Research Institute .
Recruiting
Troy,Adnan Alazizi email: [email protected] -- Qaiser Shafiq,48084 - Michigan,United States
Heart Center Research Llc .
Recruiting
Huntsville,Hannah Winkles (256-519-8255) email: [email protected] -- Kaushik K Jain,35801 - Alabama,United States
Clinical Research of Rock Hill
Recruiting
Rock Hill,Treacy McTier (803-251-9502) email: [email protected] -- Michael Denenberg,29732 - South Carolina,United States
SEC Clinical Research Research
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Dothan,Olga Stafford email: [email protected] -- Robert I Garver,36305 - Alabama,United States
Heart Clinic of Hammond .
Recruiting
Hammond,Juliana Roberts (985-269-7106) email: [email protected] -- Ghiath Mikdadi,70403 - Louisiana,United States
Dominion Medical Associates
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Richmond,(804-836-6540) -- Richard A Jackson,23219 - Virginia,United States
St Johns Center Research
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Ponte Vedra,Kimberly McKenzie email: [email protected] -- Ameeth Vedre,32801 - Florida,United States
Inpatient Research Clinical LLC
Recruiting
Miami Lakes,(786-502-4303) -- Alexis Gutierrez,33014 - Florida,United States
East Coast Institute for Research East Coast Inst for Res ECIR
Recruiting
Jacksonville,Leann Petschonek email: [email protected] -- Jerry W Chandler,32223 - Florida,United States
St Louis Heart and Vascular .
Recruiting
Saint Louis,Amber Mica (314-741-0911) email: [email protected] -- Mohammad Tahir,63136 - Missouri,United States
Jacksonville Ctr for Clin Rea Main Centre
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Jacksonville,Robyn Pelletier (904-730-0101) email: [email protected] -- Michael J Koren,32216 - Florida,United States
Fairview Health Services St Johns
Recruiting
Saint Paul,Alexandra Clute email: [email protected] -- Les Forgosh,55103 - Minnesota,United States
Tennessee Center For Clinical Trials .
Recruiting
Tullahoma,Bethany Jernigan (931-461-2663) email: [email protected] -- Dinesh Gupta,37388 - Tennessee,United States
American Clinical Trials
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Acworth,Iasia Williams email: [email protected] -- Chinedu Nweke,30101 - Georgia,United States
Miami Clinical Research .
Recruiting
Miami,Mariana Wefer email: [email protected] -- Keila Hoover,33155 - Florida,United States
Grace Research .
Recruiting
Marshall,Kristen Terry (318-626-5180) email: [email protected] -- William Eaves,75670 - Texas,United States
Anderson Medical Research Main Center
Recruiting
Fort Washington,Felton Anderson,20744 - Maryland,United States
The Research Group Lewis Hargett Circle
Recruiting
Lexington,Jennifer Nichols email: [email protected] -- Justin Arambasick,40503 - Kentucky,United States
Worldwide Contacts
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