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Clinical Trials/NL-OMON51129
NL-OMON51129
Completed
Not Applicable

Cardionomic Cardiac Pulmonary Nerve Stimulation Pilot Study - CPNS Pilot Study

Cardionomic Inc0 sites10 target enrollmentTBD

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.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Interventional

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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