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Cardionomic STOP-ADHF Study

Primary Purpose

Acute Decompensated Heart Failure

Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
CPNS Therapy
Standard of care
Sponsored by
Cardionomic Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Decompensated Heart Failure focused on measuring Neurostimulation, Contractility, Right Pulmonary Artery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St. Vincent Hospital
  • Summa Health
  • The Christ Hospital
  • University Hospitals
  • The Ohio State University
  • Oklahoma Heart Hospital South
  • TriStar Centennial Medical Center
  • Medical City Fort Worth
  • Baylor College of Medicine
  • OLV Ziekenhuis
  • AZ Sint-Jan Brugge
  • Antwerp University Hospital
  • University Medical Center Groningen
  • St. Antonius Ziekenhuis
  • Punta Pacifica

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

CPNS Therapy

Standard of Care

Arm Description

Treatment with CPNS system: Endovascular stimulation of the cardiac autonomic nerves in addition to standard of care

Available standard treatment

Outcomes

Primary Outcome Measures

Safety Measures
The occurrence of all system and/or procedure related adverse events and serious adverse events and deaths

Secondary Outcome Measures

Full Information

First Posted
March 10, 2021
Last Updated
September 25, 2023
Sponsor
Cardionomic Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04814134
Brief Title
Cardionomic STOP-ADHF Study
Official Title
The STOP-ADHF Study: Stimulation of the Cardiopulmonary Nervous System in Acute Decompensated Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 12, 2021 (Actual)
Primary Completion Date
September 24, 2023 (Actual)
Study Completion Date
February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cardionomic Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Decompensated Heart Failure
Keywords
Neurostimulation, Contractility, Right Pulmonary Artery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Subjects will be enrolled in CPNS treatment arm or to the control arm. Treatment with CPNS system includes endovascular stimulation of the cardiac autonomic nerves in addition to standard of care. Subjects in the control arm will receive the available standard treatment.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CPNS Therapy
Arm Type
Experimental
Arm Description
Treatment with CPNS system: Endovascular stimulation of the cardiac autonomic nerves in addition to standard of care
Arm Title
Standard of Care
Arm Type
Other
Arm Description
Available standard treatment
Intervention Type
Device
Intervention Name(s)
CPNS Therapy
Intervention Description
Endovascular stimulation of the cardiac autonomic nerves in addition to standard of care
Intervention Type
Other
Intervention Name(s)
Standard of care
Intervention Description
Available standard treatment
Primary Outcome Measure Information:
Title
Safety Measures
Description
The occurrence of all system and/or procedure related adverse events and serious adverse events and deaths
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
St. Vincent Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Summa Health
City
Akron
State/Province
Ohio
ZIP/Postal Code
44309
Country
United States
Facility Name
The Christ Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
University Hospitals
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Oklahoma Heart Hospital South
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73135
Country
United States
Facility Name
TriStar Centennial Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Medical City Fort Worth
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
OLV Ziekenhuis
City
Aalst
Country
Belgium
Facility Name
AZ Sint-Jan Brugge
City
Bruges
Country
Belgium
Facility Name
Antwerp University Hospital
City
Edegem
Country
Belgium
Facility Name
University Medical Center Groningen
City
Groningen
Country
Netherlands
Facility Name
St. Antonius Ziekenhuis
City
Nieuwegein
ZIP/Postal Code
3435CM
Country
Netherlands
Facility Name
Punta Pacifica
City
Panama City
Country
Panama

12. IPD Sharing Statement

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Cardionomic STOP-ADHF Study

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