Cardionomic STOP-ADHF Study

Not Applicable

Completed

• Conditions: Acute Decompensated Heart Failure
• Interventions: Device: CPNS Therapy; Other: Standard of care

• Registration Number: NCT04814134
• Lead Sponsor: Cardionomic Inc.

Brief Summary

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.

Detailed Description

The STOP-ADHF is a prospective, two-arm, multi-center study to evaluate the safety and performance of the CPNS System in patients with acute decompensated heart failure (ADHF).

The CPNS System is a neuromodulation system, intended to provide acute (≤5 days) endovascular stimulation of the cardiac autonomic nerves in the right pulmonary artery. The system consists of a temporary neuromodulation stimulator catheter and a stimulator.

Approximately 90 patients will be enrolled in the study and will be followed up through 6-months post-discharge from the hospital. Patients enrolled in the treatment group will receive CPNS therapy and followed closely in an intensive care unit setting. Patients enrolled in the control arm in will receive standard treatment for their heart failure.

Study Timeline

• Study First Submitted: 2021-03-10
• Study First Submitted QC: 2021-03-22
• Study First Posted: 2021-03-24
• Study Start: 2021-04-12
• Primary Completion: 2023-09-24
• Status Verified: 2024-02
• Study Completion: 2024-02-13
• Last Update Submitted: 2024-02-26
• Last Update Posted: 2024-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

Inclusion Criteria

• 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)

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CPNS Therapy	CPNS Therapy	Treatment with CPNS system: Endovascular stimulation of the cardiac autonomic nerves in addition to standard of care
CPNS Therapy	Standard of care	Treatment with CPNS system: Endovascular stimulation of the cardiac autonomic nerves in addition to standard of care
Standard of Care	Standard of care	Available standard treatment

Primary Outcome Measures

Name	Time	Method
Safety Measures	6 months	The occurrence of all system and/or procedure related adverse events and serious adverse events and deaths

Trial Locations

Locations (15)

University Medical Center Groningen; 🇳🇱 Groningen, Netherlands

Oklahoma Heart Hospital South; 🇺🇸 Oklahoma City, Oklahoma, United States

Medical City Fort Worth; 🇺🇸 Fort Worth, Texas, United States

St. Antonius Ziekenhuis; 🇳🇱 Nieuwegein, Netherlands

Summa Health; 🇺🇸 Akron, Ohio, United States

University Hospitals; 🇺🇸 Cleveland, Ohio, United States

The Ohio State University; 🇺🇸 Columbus, Ohio, United States

St. Vincent Hospital; 🇺🇸 Indianapolis, Indiana, United States

The Christ Hospital; 🇺🇸 Cincinnati, Ohio, United States

TriStar Centennial Medical Center; 🇺🇸 Nashville, Tennessee, United States

Baylor College of Medicine; 🇺🇸 Houston, Texas, United States

Antwerp University Hospital; 🇧🇪 Edegem, Belgium

AZ Sint-Jan Brugge; 🇧🇪 Bruges, Belgium

OLV Ziekenhuis; 🇧🇪 Aalst, Belgium

Punta Pacifica; 🇵🇦 Panama City, Panama