Clinical trial NCT04814134: Cardionomic STOP-ADHF Study
Official title: The STOP-ADHF Study: Stimulation of the Cardiopulmonary Nervous System in Acute Decompensated Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Decompensated Heart Failure
Keywords: Neurostimulation
Contractility
Right Pulmonary Artery
Lead sponsor: Cardionomic Inc.
Sponsor class: INDUSTRY
First posted: 2021-03-24
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Safety Measures
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: St. Vincent Hospital
state: Indiana
city: Akron
country: United States
facility: Summa Health
state: Ohio
city: Cincinnati
country: United States
facility: The Christ Hospital
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma Heart Hospital South
state: Oklahoma
city: Nashville
country: United States
facility: TriStar Centennial Medical Center
state: Tennessee
city: Fort Worth
country: United States
facility: Medical City Fort Worth
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Aalst
country: Belgium
facility: OLV Ziekenhuis
city: Bruges
country: Belgium
facility: AZ Sint-Jan Brugge
city: Edegem
country: Belgium
facility: Antwerp University Hospital
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis
city: Panama City
country: Panama
facility: Punta Pacifica
Study officials:
References: