Status:
COMPLETED
Safety and Tolerability Study of XXB750 in Heart Failure Participants With Reduced or Mildly Reduced Ejection Fraction (HFrEF/HFmrEF)
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Heart Failure With Reduced Ejection Fraction (HFrEF)
or Heart Failure With Mildly Reduced Ejection Fraction (HFmrEF)
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
Brief Summary
This is a multi-center, randomized, sponsor open-label, participant- and investigator-blinded, placebo-controlled, single and multiple dose study to investigate the safety and tolerability of XXB750 i...
Detailed Description
A screening period of up to 29 days will be used to assess participants' eligibility. This study will consist of 2 cohorts. Cohort 1 will include participants on stable therapies of ACEi/ARB and beta-...
Eligibility Criteria
Inclusion
- Key Inclusion Criteria:
- NYHA functional class II-III
- LVEF ≤ 50% documented at screening
- Systolic blood pressure 110 - 160 mmHg (cohort 1) or 105-160 mmHg (cohort 2), and heart rate between 50-90 beats per minute, inclusive
- Treatment with a stable dose of a beta blocker.
- Cohort 1: Treatment with a stable dose of ACE inhibitor or ARB
- Cohort 2: Treatment with a stable dose of sacubitril/valsartan.
- Key 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: Treatment with ACE inhibitor or ARB currently or within 4 weeks from screening
- BMI \>40 kg/m2
- Other protocol-specific criteria may apply.
Exclusion
Key Trial Info
Start Date :
May 17 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 18 2024
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT05328752
Start Date
May 17 2022
End Date
January 18 2024
Last Update
September 30 2025
Active Locations (4)
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1
Nature Coast Clinical Research LLC
Inverness, Florida, United States, 34452
2
Jacksonville Ctr for Clin Rea Main Centre
Jacksonville, Florida, United States, 32216
3
Fairview Health Services .
Saint Paul, Minnesota, United States, 55102
4
Novartis Investigative Site
Groningen, Netherlands, 9713 GZ