NCT04814134Completed
Cardionomic STOP-ADHF Study
The STOP-ADHF Study: Stimulation of the Cardiopulmonary Nervous System in Acute Decompensated Heart Failure
Source: ClinicalTrials.gov · Last updated 28 Feb 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 59 (actual)
- First submitted
- 10 Mar 2021
- Start date
- 12 Apr 2021
- Primary completion date
- 24 Sept 2023
- Lead sponsor
- Cardionomic Inc.
- Diseases
- Heart failure
- NCT number
- NCT04814134
What you commit to
- Study type: Interventional
- Participants enrolled: 59
- From 12 Apr 2021 to the primary completion date, 24 Sept 2023
- 15 sites in 4 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Received a high dose inotrope or Levosimendan during current hospitalization or treatment with a low dose inotriope within 24 hours before enrollment
Lab values
- eGFR \< 25 mL/min/1.732
Other
- Requires mechanical support
- Cardiogenic shock or impending cardiogenic shock
- Systolic blood pressure \< 80mmHg or \> 140mmHg
- Symptomatic hypotension
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (15)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| OLV Ziekenhuis Coordinator of this site? Confirm its status | Aalst | Belgium | Unknown status |
| Az Sint Jan Brugge Coordinator of this site? Confirm its status | Bruges | Belgium | Unknown status |
| Antwerp University Hospital Coordinator of this site? Confirm its status | Edegem | Belgium | Unknown status |
| University Medical Center Groningen Coordinator of this site? Confirm its status | Groningen | Netherlands | Unknown status |
| St. Antonius Ziekenhuis Coordinator of this site? Confirm its status | Nieuwegein | Netherlands | Unknown status |
| Punta Pacifica Coordinator of this site? Confirm its status | Panama City | Panama | Unknown status |
| Summa Health Coordinator of this site? Confirm its status | Akron | United States | Unknown status |
| The Christ Hospital Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| University Hospitals Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| The Ohio State University Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| Medical City Fort Worth Coordinator of this site? Confirm its status | Fort Worth | United States | Unknown status |
| Baylor College of Medicine Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| St Vincent Hospital Coordinator of this site? Confirm its status | Indianapolis | United States | Unknown status |
| TriStar Centennial Medical center Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Oklahoma Heart Hospital South Coordinator of this site? Confirm its status | Oklahoma City | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.