Acute Decompensated Heart FailureNCT04814134
Cardionomic STOP-ADHF Study
A study testing CPNS Therapy in people with Acute Decompensated Heart Failure, run by Cardionomic Inc. at 15 sites in 4 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Decompensated Heart Failure
- What is being tested?
- CPNS Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 15 sitesin 4 countries
- Study dates
- 12 Apr 2021to 13 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
15 sites in 4 countries.
15 sites in 4 countries
United States9 sites
Summa Health
Akron, Ohio, 44309
The Christ Hospital
Cincinnati, Ohio, 45219
University Hospitals
Cleveland, Ohio, 44106
The Ohio State University
Columbus, Ohio, 43210
Medical City Fort Worth
Fort Worth, Texas, 76104
Baylor College of Medicine
Houston, Texas, 77030
St. Vincent Hospital
Indianapolis, Indiana, 46260
TriStar Centennial Medical Center
Nashville, Tennessee, 37203
Oklahoma Heart Hospital South
Oklahoma City, Oklahoma, 73135
Belgium3 sites
OLV Ziekenhuis
Aalst
AZ Sint-Jan Brugge
Bruges
Antwerp University Hospital
Edegem
Netherlands2 sites
University Medical Center Groningen
Groningen
St. Antonius Ziekenhuis
Nieuwegein, 3435CM
About this study
Official title: The STOP-ADHF Study: Stimulation of the Cardiopulmonary Nervous System in Acute Decompensated Heart Failure
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.
Read the 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.
- Conditions
- Acute Decompensated Heart Failure
- Being tested
- CPNS Therapy, Standard of care
- Keywords
- Neurostimulation, Contractility, Right Pulmonary Artery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPNS TherapyDevice
Endovascular stimulation of the cardiac autonomic nerves in addition to standard of care
Standard of careOther
Available standard treatment
| Study group | Role | What they receive |
|---|---|---|
| CPNS Therapy | Experimental | Treatment with CPNS system: Endovascular stimulation of the cardiac autonomic nerves in addition to standard of care Receives: Device: CPNS Therapy; Other: Standard of care |
| Standard of Care | Other | Available standard treatment Receives: Other: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Measures
The occurrence of all system and/or procedure related adverse events and serious adverse events and deaths
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2021
- Study start12 Apr 2021
- Primary completion24 Sep 2023
- Study completion13 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Decompensated Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardionomic Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04814134
- Sponsor's protocol ID
- CLN-1051-001
- Status last verified
- Feb 2024
- First submitted
- 10 Mar 2021
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The STOP-ADHF Study: Stimulation of the Cardiopulmonary Nervous System in Acute Decompensated Heart Failure
- ClinicalTrials.gov ID
- NCT04814134
- Acronym / sponsor ID
- CLN-1051-001
- Conditions
- Acute Decompensated Heart Failure
- Keywords
- Neurostimulation, Contractility, Right Pulmonary Artery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Cardionomic Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Apr 2021 (actual)
- Primary completion
- 24 Sep 2023 (actual)
- Study completion
- 13 Feb 2024 (actual)
- First posted
- 24 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| CPNS Therapy | Experimental | Device: CPNS Therapy, Other: Standard of careTreatment with CPNS system: Endovascular stimulation of the cardiac autonomic nerves in addition to standard of care |
| Standard of Care | Other | Other: Standard of careAvailable standard treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPNS TherapyEndovascular stimulation of the cardiac autonomic nerves in addition to standard of care | Device | CPNS Therapy |
| Standard of careAvailable standard treatment | Other | CPNS Therapy, Standard of Care |
Primary outcome
Safety Measures
Time frame: 6 months
The occurrence of all system and/or procedure related adverse events and serious adverse events and deaths
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPNS Therapy in people with Acute Decompensated Heart Failure, run by Cardionomic Inc. at 15 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States, Belgium, Netherlands, Panama. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety Measures (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024; AzTrials last refreshed its copy on 27 Oct 2026.