Cardionomic STOP-ADHF Study

The STOP-ADHF Study: Stimulation of the Cardiopulmonary Nervous System in Acute Decompensated Heart Failure

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.

Study Overview

• Status: Completed
• Conditions: Acute Decompensated Heart Failure
• Intervention / Treatment: Device: CPNS Therapy; Other: Standard of care

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 Type: Interventional
• Enrollment (Actual): 59
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michelle Kennefick; Phone Number: 6516331388; Email: clinical@cardionomicinc.com

Study Locations

• Belgium
  • Aalst, Belgium
    • OLV Ziekenhuis
  • Bruges, Belgium
    • AZ Sint-Jan Brugge
  • Edegem, Belgium
    • Antwerp University Hospital
• Netherlands
  • Groningen, Netherlands
    • University Medical Center Groningen
  • Nieuwegein, Netherlands, 3435CM
    • St. Antonius Ziekenhuis
• Panama
  • Panama City, Panama
    • Punta Pacifica
• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46260
      • St. Vincent Hospital
  • Ohio
    • Akron, Ohio, United States, 44309
      • Summa Health
    • Cincinnati, Ohio, United States, 45219
      • The Christ Hospital
    • Cleveland, Ohio, United States, 44106
      • University Hospitals
    • Columbus, Ohio, United States, 43210
      • The Ohio State University
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73135
      • Oklahoma Heart Hospital South
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • TriStar Centennial Medical center
  • Texas
    • Fort Worth, Texas, United States, 76104
      • Medical City Fort Worth
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CPNS Therapy; Treatment with CPNS system: Endovascular stimulation of the cardiac autonomic nerves in addition to standard of care	Device: CPNS Therapy; Endovascular stimulation of the cardiac autonomic nerves in addition to standard of care; Other: Standard of care; Available standard treatment
Other: Standard of Care; Available standard treatment	Other: Standard of care; Available standard treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Measures	The occurrence of all system and/or procedure related adverse events and serious adverse events and deaths	6 months

Collaborators and Investigators

• Sponsor: Cardionomic Inc.

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2021
• Primary Completion (Actual): September 24, 2023
• Study Completion (Actual): February 13, 2024

Study Registration Dates

• First Submitted: March 10, 2021
• First Submitted That Met QC Criteria: March 22, 2021
• First Posted (Actual): March 24, 2021

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 26, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Contractility; Neurostimulation; Right Pulmonary Artery
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: CLN-1051-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes