To find out what dose of XXB750 is working and safe to use in patients with heart failure
- Conditions
- Health Condition 1: I509- Heart failure, unspecified
- Registration Number
- CTRI/2024/05/066974
- Lead Sponsor
- ovartis Healthcare Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the efficacy and dose-response relationshipTimepoint: Every 04 weeks until 24 weeks
- Secondary Outcome Measures
Name Time Method To evaluate the treatment effect of the highest XXB750 target dose level compared to placeboTimepoint: Test will be performed every 04 week until 24 weeks;What adverse events do the participants have during the trial?Timepoint: Every 02 weeks until 24 weeks