BridgeMD
A proof of concept and dose-finding study of XXB750 in patients with heart failure
EU CTIS ID: 2023-504678-39-00
What this study is testing
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.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- 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.
- Office systolic blood pressure (SBP) ≥ 180 mmHg or < 105 mmHg at screening or at randomization.
- In subjects with ACEI/ARB medication at screening, previous inability to tolerate any dose of sacubitril/valsartan (as per the investigator's judgment).
- 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.
- Known history of angioedema.
See the full eligibility criteria
- 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.
- 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.
- Office systolic blood pressure (SBP) ≥ 180 mmHg or < 105 mmHg at screening or at randomization.
- In subjects with ACEI/ARB medication at screening, previous inability to tolerate any dose of sacubitril/valsartan (as per the investigator's judgment).
- 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.
- Known history of angioedema.
The study team makes the final eligibility decision.
Where it's taking place
- Japan
- United Kingdom
- China
- Taiwan
- Brazil
- South Africa
- United States
- India
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Japan; United Kingdom; China; Taiwan; Brazil; South Africa and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.