Cardionomic STOP-ADHF Study

Acute Decompensated Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04814134
• Other study ID #: CLN-1051-001
• Status: Completed
• Phase: N/A
• Start date: April 12, 2021
• Est. completion date: February 13, 2024

Study information

• Verified date: February 2024
• Source: Cardionomic Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: February 13, 2024
• Est. primary completion date: September 24, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Decompensated Heart Failure
• Heart Failure

Intervention

Device:
• CPNS Therapy
Endovascular stimulation of the cardiac autonomic nerves in addition to standard of care

Other:
• Standard of care
Available standard treatment

Locations

Country	Name	City	State
Belgium	OLV Ziekenhuis	Aalst
Belgium	AZ Sint-Jan Brugge	Bruges
Belgium	Antwerp University Hospital	Edegem
Netherlands	University Medical Center Groningen	Groningen
Netherlands	St. Antonius Ziekenhuis	Nieuwegein
Panama	Punta Pacifica	Panama City
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	Medical City Fort Worth	Fort Worth	Texas
United States	Baylor College of Medicine	Houston	Texas
United States	St. Vincent Hospital	Indianapolis	Indiana
United States	TriStar Centennial Medical Center	Nashville	Tennessee
United States	Oklahoma Heart Hospital South	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Cardionomic Inc.

Countries where clinical trial is conducted

United States,  Belgium,  Netherlands,  Panama, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety Measures	The occurrence of all system and/or procedure related adverse events and serious adverse events and deaths	6 months