NL-OMON51129
Completed
Not Applicable
Cardionomic Cardiac Pulmonary Nerve Stimulation Pilot Study - CPNS Pilot Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Acute congestive heart failure
- Sponsor
- Cardionomic Inc
- Enrollment
- 10
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects must meet all the following inclusion criteria to be eligible to
- •participate in this study:
- •1\. At least 18 years of age, or older if required by local law
- •2\. Admitted to the hospital with a principal diagnosis of acute decompensated
- •heart failure.
- •3\. BMI adjusted BNP \>\= 500 pg/mL or NT\-pro\-BNP \>\= 2000 pg/mL; 4% reduction in
- •BNP/NT\-proBNP for every increase of 1 kg/m2 in BMI above a reference of 20kg/m2
- •(Refer to Appendix B: BNP/NT\-proBNP corrected for BMI)
- •4\. Left ventricular ejection fraction \<\= 45%; documented within previous 12
- •5\. At least one sign or symptom of fluid overload
Exclusion Criteria
- •1\. First IV treatment upon presentation in hospital to randomization is \> 48
- •2\. Received an inotrope during current hospitalization or anticipated to
- •receive an inotrope in the 12 hours following enrollment
- •3\. Requires mechanical support (e.g., mechanical circulatory support,
- •ultrafiltration) or anticipated to receive mechanical support in the 12 hours
- •following enrollment
- •4\. Manually measured systolic blood pressure \< 80 mmHg at screening
- •5\. Manually measured systolic blood pressure \> 130 mmHg at screening
- •6\. Symptomatic hypotension
- •7\. eGFR \< 25 mL/min/1\.73m2
Outcomes
Primary Outcomes
Not specified
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