Cardionomic STOP-ADHF Study

Cardionomic

Status: Completed

Conditions: Acute Decompensated Heart Failure

Treatments: Other: Standard of care; Device: CPNS Therapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT04814134

CLN-1051-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 59 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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59 participants in 2 patient groups

CPNS Therapy

Experimental group

Description:

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

Treatment:

Device: CPNS Therapy

Other: Standard of care

Standard of Care

Other group

Description:

Available standard treatment

Treatment:

Other: Standard of care