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
Gladbeck,45968,Germany
Novartis Investigative Site
Recruiting
Kawasaki-city,Kanagawa,216-8511,Japan
Novartis Investigative Site
Recruiting
Koriyama,Fukushima,963-8501,Japan
Novartis Investigative Site
Recruiting
Matsumoto,Nagano,390-8621,Japan
Novartis Investigative Site
Recruiting
Vila Nova De Gaia,4434 502,Portugal
Novartis Investigative Site
Recruiting
El Palmar,Murcia,30120,Spain
Novartis Investigative Site
Recruiting
Kaohsiung,80756,Taiwan
Revival Research Institute .
Recruiting
Troy,Adnan Alazizi email: [email protected] -- Qaiser Shafiq,48084 - Michigan,United States
Anderson Medical Research Main Center
Recruiting
Fort Washington,Felton Anderson,20744 - Maryland,United States
Heart Clinic of Hammond .
Recruiting
Hammond,(985-269-7106) -- Ghiath Mikdadi,70403 - Louisiana,United States
SEC Clinical Research Research
Recruiting
Dothan,Olga Stafford email: [email protected] -- Robert I Garver,36305 - Alabama,United States
Aultman Hospital
Recruiting
Canton,Ataul Qureshi,44710 - Ohio,United States
Inpatient Research Clinical LLC
Recruiting
Miami Lakes,(786-502-4303) -- Alexis Gutierrez,33014 - Florida,United States
St Johns Center Research
Recruiting
Ponte Vedra,Kimberly McKenzie email: [email protected] -- Ameeth Vedre,32801 - Florida,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
Jacksonville Ctr for Clin Rea Main Centre
Recruiting
Jacksonville,Robyn Pelletier (904-730-0101) email: [email protected] -- Michael J Koren,32216 - 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
Dominion Medical Associates
Recruiting
Richmond,(804-836-6540) -- Richard A Jackson,23219 - Virginia,United States
Nature Coast Clinical Research LLC
Recruiting
Inverness,Donald Bowen (352-341-2100) email: [email protected] -- Rafik Abadier,34452 - Florida,United States
Tennessee Center For Clinical Trials .
Recruiting
Tullahoma,Bethany Jernigan (931-461-2663) email: [email protected] -- Dinesh Gupta,37388 - Tennessee,United States
Grace Research .
Recruiting
Marshall,Kristen Terry (318-626-5180) email: [email protected] -- William Eaves,75670 - Texas,United States
The Research Group Lewis Hargett Circle
Recruiting
Lexington,Jennifer Nichols email: [email protected] -- Justin Arambasick,40503 - Kentucky,United States
Grace Research Llc .
Recruiting
Shreveport,Taylor Moore (318-626-5180) email: [email protected] -- Anil Chhabra,71101 - Louisiana,United States
Pima Heart And Vascular Clin Rch .
Recruiting
Tucson,Natheer Aljanabi (520-838-3540) email: [email protected] -- Ajay Tuli,85704 - Arizona,United States
American Clinical Trials
Recruiting
Acworth,Iasia Williams email: [email protected] -- Chinedu Nweke,30101 - Georgia,United States
Heart Center Research Llc .
Recruiting
Huntsville,Hannah Winkles (256-519-8255) email: [email protected] -- Kaushik K Jain,35801 - Alabama,United States
Worldwide Contacts
If the location of your choosing does not feature any contact detail, please reach out using the information below.