A randomized, participant and investigator blinded, sponsor open-label, placebo-controlled, single and multiple dose study to investigate the safety and tolerability of XXB750 in heart failure participants with reduced or mildly reduced ejection fraction (HFrEF/HFmrEF)

Completed

• Conditions: Chronic heart failure; reduced ejection fraction; 10082206

• Registration Number: NL-OMON53896
• Lead Sponsor: ovartis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 4

Inclusion Criteria

• Men or women age 18 to 80 years
• NYHA functional class II-III
• LVEF <= 50%
• Systolic blood pressure (SBP) 110 - 160 mmHg (Cohort 1) or SBP 105 - 160 mmHg
(Cohort 2), and heart rate 50 - 90 beats per minute inclusive, at screening
• Cohort 1 only: On stable therapies of ACEi/ARB for at least 4 weeks prior to
screening.
• Cohort 2 only: On a stable dose of sacubitril/valsartan for at least 4 weeks
prior to screening.
• Treatment with a stable dose of a beta blocker for at least 4 weeks prior to
screening, unless contraindicated or not tolerated.

Exclusion Criteria

• Acute decompensated heart failure within 3 months prior to screening. Acute
coronary syndrome, stroke, transient ischemic attack, cardiac, carotid, or
other major cardiovascular surgery, PCI, or carotid angioplasty within the 6
months prior to screening
• Hemodynamically significant mitral and/or aortic valve disease, except mitral
regurgitation secondary to LV dilatation at screening
• Implantation of a CRT device within 3 months prior to screening or intent to
implant a CRT during the study period
• History of severe pulmonary disease (e.g. COPD) requiring chronic
supplemental oxygen therapy or pulmonary hypertension requiring pharmacology
treatment at Screening
• eGFR <45 mL/min/1.73 m2 at screening
• Cohort 1 only: Treatment with sacubitril/valsartan currently or within 4
weeks from screening
• Cohort 2 only: Treatment with ACEi or ARB currently or within 4 weeks from
screening. Valsartan as part of sacubitril/valsartan is not an exclusion.
• BMI >40 kg/m2

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To evaluate the safety and tolerability of a XXB750 in adult participants with<br /><br>chronic stable heart failure with reduced or mildly reduced ejection fraction<br /><br>(HFrEF/HFmrEF). Endpoints: adverse events, vital signs (blood pressure, pulse),<br /><br>safety laboratory tests, ECG parameters</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To evaluate the pharmacokinetics of XXB750 in adult participants with<br /><br>HFrEF/HFmrEF (XXB750 Tmax, Cmax, AUClast, AUCinf, CL/F, Vz/F, and T1/2)</p><br>