Cardionomic STOP-ADHF Study

Completed · Not applicable

Conditions studied: Acute Decompensated Heart Failure

In brief

STOP-ADHF Study: An evaluation of the safety and performance of the Cardionomic Cardiac Pulmonary Nerve Stimulation (CPNS) system in patients with acute decompensated heart failure.

Key facts

Study ID

NCT04814134

Run by

Cardionomic Inc.

People needed

59

Starts

2021-04-12

Expected to finish

2024-02-13

Last updated by the study team

2024-02-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Admitted to hospital with a principal diagnosis of ADHF
• BMI adjusted BNP ≥ 500 pg/mL or NT-proBNP ≥ 2000 pg/mL
• LVEF ≤ 50%
• At least one sign or symptom of fluid overload despite the administration of IV furosemide (or equivalent) (at least 40 mg or equivalent)

You may not qualify if…

• Received a high dose inotrope or Levosimendan during current hospitalization or treatment with a low dose inotriope within 24 hours before enrollment
• Requires mechanical support
• Cardiogenic shock or impending cardiogenic shock
• Systolic blood pressure < 80mmHg or > 140mmHg
• Symptomatic hypotension
• eGFR < 25 mL/min/1.732

Where it is running

• St. Vincent Hospital — Indianapolis, Indiana, United States
• Summa Health — Akron, Ohio, United States
• The Christ Hospital — Cincinnati, Ohio, United States
• University Hospitals — Cleveland, Ohio, United States
• The Ohio State University — Columbus, Ohio, United States
• Oklahoma Heart Hospital South — Oklahoma City, Oklahoma, United States
• TriStar Centennial Medical Center — Nashville, Tennessee, United States
• Medical City Fort Worth — Fort Worth, Texas, United States
• Baylor College of Medicine — Houston, Texas, United States
• OLV Ziekenhuis — Aalst, Belgium
• AZ Sint-Jan Brugge — Bruges, Belgium
• Antwerp University Hospital — Edegem, Belgium
• University Medical Center Groningen — Groningen, Netherlands
• St. Antonius Ziekenhuis — Nieuwegein, Netherlands
• Punta Pacifica — Panama City, Panama

Full record on ClinicalTrials.gov

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