Cardionomic STOP-ADHF Study

February 26, 2024 updated by: Cardionomic Inc.

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 6 months
The occurrence of all system and/or procedure related adverse events and serious adverse events and deaths
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cardionomic Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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