A proof of concept and dose-finding study of XXB750 in patients with heart failure
Key facts
- Where
- Balatonfüred, Budapest IX, Budapest XII, Budapest XIII, Budapest XIV, Debrecen, Kalocsa, Mosonmagyaróvár, Pécs és Szeged, MagyarországSee the 10 sites
- Phase
- 2. fázis
Where in Magyarország
- DRC Kft.Balatonfüred, MagyarországNo longer taking part
- Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai IntezetBudapest IX, MagyarországNo longer taking part
- Semmelweis UniversityBudapest XII, MagyarországNo longer taking part
- Central Hospital Of Northern Pest Military HospitalBudapest XIII, MagyarországNo longer taking part
- Budapesti Uzsoki Utcai KorhazBudapest XIV, MagyarországNo longer taking part
- University of DebrecenDebrecen, MagyarországNo longer taking part
- Studium Egeszseghaz KftKalocsa, MagyarországNo longer taking part
- TaNa Med Kft.Mosonmagyaróvár, MagyarországNo longer taking part
- University of PecsPécs, MagyarországNo longer taking part
- University of SzegedSzeged, MagyarországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Novartis Pharma AG
- Trial code
- EU 2023-504678-39-00
- Record updated
- 2024. november 8.
- Original description
To evaluate the efficacy and dose-response relationship of three XXB750 target dose levels compared to placebo in reducing N-terminal prohormone B-type natriuretic peptide (NT-proBNP) from baseline to Week 16 in symptomatic HF patients with LVEF < 50% treated with standard of care, including ACEI/ARB or sacubitril/valsartan.Read full original descriptionShow less
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
To evaluate the efficacy and dose-response relationship of three XXB750 target dose levels compared to placebo in reducing N-terminal prohormone B-type natriuretic peptide (NT-proBNP) from baseline to Week 16 in symptomatic HF patients with LVEF < 50% treated with standard of care, including ACEI/ARB or sacubitril/valsartan.
Inclusion: Written informed consent must be obtained before any assessment is performed; Male and female outpatients who are ≥ 18 years old; Symptom(s) of HF NYHA class II-III at Screening; LVEF < 50% (most recent local measurement, made within 6 months prior to or during screening using echocardiography, MUGA, CT scanning, MRI or ventricular angiography is acceptable, provided no subsequent measurement ≥ 50%); NT-proBNP ≥ 600 pg/ml if in sinus rhythm or NT-proBNP ≥ 900 pg/ml if in atrial fibrillation/flutter at Screening; Receiving an ACEI or an ARB at a stable dose of at least enalapril 10 mg/d or equivalent for at least 4 weeks before Screening or receiving sacubitril/valsartan at a stable dose of at least 49/51 mg bid for at least 4 weeks before Screening; Receiving other guideline recommended HF therapies as deemed appropriate by the investigator and that are stable for at least 4 weeks before Screening, unless contraindicated, not tolerated, or not available to patient.
Exclusion: Current acute decompensated HF (exacerbation of chronic HF manifested by signs and symptoms that may require intravenous therapy) or hospitalization for HF within 3 months prior to screening; In subjects with ACEI/ARB medication at screening, previous inability to tolerate any dose of sacubitril/valsartan (as per the investigator's judgment); Known history of angioedema; Serum potassium > 5.4 mmol/L at screening; Estimated GFR (eGFR) < 30 mL/min/1.73m2 at screening as measured by the CKD-EPI formula; Office systolic blood pressure (SBP) ≥ 180 mmHg or < 105 mmHg at screening or at randomization.