Last updated: August 25, 2023
Sponsor: Biofourmis Inc
Overall Status: Active - Recruiting
Phase
N/A
Condition
Heart Failure
Treatment
N/AClinical Study ID
TX310270
BV-EV-HF-1901
Ages 22-100 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Diagnosis of heart failure (left ventricular ejection fraction ≤ 40%
- New York Heart Association (NYHA) class II-III at most recent screening assessment
- HFrEF patients not on GDMT defined as:
- Use of GDMT less than 50% recommended target dose of at least one HF GDMT
- Use of GDMT at 50% to <100% recommended target doses of two HF GDMTs
Exclusion
Exclusion Criteria:
- Absolute Contraindications to GDMT
- Baseline creatinine > 2 mg/dl or potassium level at baseline > 5 mEq/L or eGFR <30 mL/min/1.73 m2
- Receiving dialysis at screening
- Baseline systolic blood pressure <100 mmHg
- History of heart or on transplant list
- Current or planned Left ventricular assist device
- Currently receiving hospice or comfort care
- Currently participating or receiving treatment in an investigational device or investigational drug study while participating in this study
- Subject unable to independently navigate and operate smartphone applications
- Subject not proficient with written and spoken English or Spanish
- Subject determined likely to be non-compliant by physician/HCP
- Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures (e.g., Clinical Outcome Assessments) to the best of the subject and investigator's knowledge.
- History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator or Biofourmis medical monitor, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.
- Subject has diminished decision making capability
Study Design
Study Start date:
Estimated Completion Date:
Study Description
Connect with a study center
Baptist Healthcare System
Lexington, Kentucky 40503
United StatesActive - Recruiting
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