Heart Failure Clinical Trial
Official title:
A Multi-center, Randomized, Placebo- and Active-controlled, Parallel-group, 24-week Proof of Concept and Dose-finding Study to Evaluate Efficacy, Safety, and Tolerability of XXB750 in Patients With Heart Failure
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.
| Status | Recruiting |
| Enrollment | 720 |
| Est. completion date | December 22, 2025 |
| Est. primary completion date | October 27, 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Bulgaria | Novartis Investigative Site | Blagoevgrad | |
| Bulgaria | Novartis Investigative Site | Gabrovo | |
| Bulgaria | Novartis Investigative Site | Kyustendil | |
| Bulgaria | Novartis Investigative Site | Pleven | |
| Bulgaria | Novartis Investigative Site | Plovdiv | |
| Bulgaria | Novartis Investigative Site | Sofia | |
| Bulgaria | Novartis Investigative Site | Sofia | |
| Bulgaria | Novartis Investigative Site | Sofia | |
| Bulgaria | Novartis Investigative Site | Stara Zagora | |
| Bulgaria | Novartis Investigative Site | Varna | |
| China | Novartis Investigative Site | Beijing | |
| China | Novartis Investigative Site | Chengdu | Sichuan |
| China | Novartis Investigative Site | Guangzhou | Guangdong |
| China | Novartis Investigative Site | Jinan | |
| China | Novartis Investigative Site | Luoyang | Henan |
| China | Novartis Investigative Site | Tianjin | Tianjin |
| Denmark | Novartis Investigative Site | Herlev | |
| Denmark | Novartis Investigative Site | Hvidovre | |
| Denmark | Novartis Investigative Site | Roskilde | |
| France | Novartis Investigative Site | Montpellier | |
| France | Novartis Investigative Site | Rouen | |
| France | Novartis Investigative Site | Toulouse 4 | |
| Germany | Novartis Investigative Site | Berlin | |
| Germany | Novartis Investigative Site | Berlin | |
| Germany | Novartis Investigative Site | Coburg | |
| Germany | Novartis Investigative Site | Dresden | |
| Germany | Novartis Investigative Site | Dresden | Sachsen |
| Germany | Novartis Investigative Site | Essen | Nordrhein Westfalen |
| Germany | Novartis Investigative Site | Frankfurt | |
| Germany | Novartis Investigative Site | Frankfurt | |
| Germany | Novartis Investigative Site | Gladbeck | |
| Germany | Novartis Investigative Site | Kiel | |
| Germany | Novartis Investigative Site | Koeln | |
| Germany | Novartis Investigative Site | Leipzig | |
| Germany | Novartis Investigative Site | Ludwigshafen | |
| Germany | Novartis Investigative Site | Ludwigshafen | |
| Germany | Novartis Investigative Site | Papenburg | |
| Germany | Novartis Investigative Site | Schwaebisch Hall | |
| Germany | Novartis Investigative Site | Stuttgart | |
| Italy | Novartis Investigative Site | Ancona | AN |
| Italy | Novartis Investigative Site | Bergamo | BG |
| Italy | Novartis Investigative Site | Brescia | BS |
| Italy | Novartis Investigative Site | Cona | FE |
| Italy | Novartis Investigative Site | Messina | ME |
| Italy | Novartis Investigative Site | Milano | MI |
| Italy | Novartis Investigative Site | Pisa | PI |
| Italy | Novartis Investigative Site | Pordenone | PN |
| Italy | Novartis Investigative Site | Reggio Emilia | RE |
| Italy | Novartis Investigative Site | Roma | RM |
| Italy | Novartis Investigative Site | Roma | RM |
| Italy | Novartis Investigative Site | Trieste | TS |
| Japan | Novartis Investigative Site | Hachioji-city | Tokyo |
| Japan | Novartis Investigative Site | Itabashi-ku | Tokyo |
| Japan | Novartis Investigative Site | Kawaguchi-city | Saitama |
| Japan | Novartis Investigative Site | Kawasaki-city | Kanagawa |
| Japan | Novartis Investigative Site | Koriyama | Fukushima |
| Japan | Novartis Investigative Site | Maebashi city | Gunma |
| Japan | Novartis Investigative Site | Matsumoto | Nagano |
| Japan | Novartis Investigative Site | Sagamihara | Kanagawa |
| Netherlands | Novartis Investigative Site | Groningen | |
| Netherlands | Novartis Investigative Site | Leeuwarden | |
| Portugal | Novartis Investigative Site | Lisboa | |
| Portugal | Novartis Investigative Site | Lisboa | |
| Portugal | Novartis Investigative Site | Vila Nova De Gaia | |
| Slovakia | Novartis Investigative Site | Bardejov | |
| Slovakia | Novartis Investigative Site | Kosice | |
| Slovakia | Novartis Investigative Site | Martin | |
| Slovakia | Novartis Investigative Site | Nitra | |
| Slovakia | Novartis Investigative Site | Nove Zamky | |
| Slovakia | Novartis Investigative Site | Presov | |
| Slovakia | Novartis Investigative Site | Svidnik | |
| Spain | Novartis Investigative Site | Alicante | |
| Spain | Novartis Investigative Site | El Palmar | Murcia |
| Spain | Novartis Investigative Site | Huelva | Andalucia |
| Spain | Novartis Investigative Site | Las Palmas de Gran Canaria | |
| Spain | Novartis Investigative Site | Madrid | |
| Spain | Novartis Investigative Site | Madrid | |
| Spain | Novartis Investigative Site | Madrid | |
| Spain | Novartis Investigative Site | Madrid | |
| Spain | Novartis Investigative Site | Malaga | Andalucia |
| Spain | Novartis Investigative Site | Santiago De Compostela | Galicia |
| Spain | Novartis Investigative Site | Sevilla | Andalucia |
| Spain | Novartis Investigative Site | Utrera | Andalucia |
| Spain | Novartis Investigative Site | Valencia | Comunidad Valenciana |
| Spain | Novartis Investigative Site | Valencia | |
| Taiwan | Novartis Investigative Site | Kaohsiung | |
| Taiwan | Novartis Investigative Site | Taichung | |
| Taiwan | Novartis Investigative Site | Tainan | |
| Taiwan | Novartis Investigative Site | Taipei | |
| United States | American Clinical Trials | Acworth | Georgia |
| United States | Aultman Hospital | Canton | Ohio |
| United States | Prisma Health Research | Columbia | South Carolina |
| United States | Cypress Heart and Vascular Center | Cypress | Texas |
| United States | Baylor University Medical Center Facility | Dallas | Texas |
| United States | SEC Clinical Research Research | Dothan | Alabama |
| United States | Anderson Medical Research Main Center | Fort Washington | Maryland |
| United States | John Peter Smith Hospital | Fort Worth | Texas |
| United States | Heart Clinic of Hammond . | Hammond | Louisiana |
| United States | Heart Center Research Llc . | Huntsville | Alabama |
| United States | Nature Coast Clinical Research LLC | Inverness | Florida |
| United States | East Coast Institute for Research East Coast Inst for Res ECIR | Jacksonville | Florida |
| United States | Jacksonville Ctr for Clin Rea Main Centre | Jacksonville | Florida |
| United States | The Research Group Lewis Hargett Circle | Lexington | Kentucky |
| United States | NexGen Research | Lima | Ohio |
| United States | Memorial Care Health System Memorialcare Long Beach | Long Beach | California |
| United States | Grace Research . | Marshall | Texas |
| United States | Miami Clinical Research . | Miami | Florida |
| United States | Inpatient Research Clinical LLC | Miami Lakes | Florida |
| United States | Ormond Beach Clinical Research | Ormond Beach | Florida |
| United States | St Johns Center Research | Ponte Vedra | Florida |
| United States | Dominion Medical Associates | Richmond | Virginia |
| United States | Clinical Research of Rock Hill | Rock Hill | South Carolina |
| United States | Laurelton Heart Specialist PC Research | Rosedale | New York |
| United States | East Coast Inst for Research LLC | Saint Augustine | Florida |
| United States | St Louis Heart and Vascular . | Saint Louis | Missouri |
| United States | Washington Univ School of Medicine | Saint Louis | Missouri |
| United States | Fairview Health Services St Johns | Saint Paul | Minnesota |
| United States | Grace Research Llc . | Shreveport | Louisiana |
| United States | Universal Research Group LLC Suite 202 | Tacoma | Washington |
| United States | Revival Research Institute . | Troy | Michigan |
| United States | Troy Internal Medicine Research . | Troy | Michigan |
| United States | Pima Heart And Vascular Clin Rch Research | Tucson | Arizona |
| United States | Tennessee Center For Clinical Trials . | Tullahoma | Tennessee |
| United States | Cardiology Partners Clinical Research Institute | Wellington | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Novartis Pharmaceuticals |
United States, Bulgaria, China, Denmark, France, Germany, Italy, Japan, Netherlands, Portugal, Slovakia, Spain, Taiwan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in log NT-proBNP from baseline to Week 16 | To evaluate the efficacy and dose-response relationship of three XXB750 target dose levels compared to placebo in reducing NT-proBNP. | Baseline to Week 16 | |
| Secondary | Change in log NT-proBNP from baseline to Week 16 | To evaluate the efficacy of the highest and combined two highest XXB750 target dose levels compared to placebo and sacubitril/valsartan, respectively, in reducing NT-proBNP. | Baseline to Week 16 |
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