Acute Decompensated Heart FailureNCT05313438
The STIM-ADHF Study
A study testing CPNS Therapy in people with Acute Decompensated Heart Failure, run by Cardionomic Inc. at 6 sites in 3 countries.
Trial summary
The STIM-ADHF Study is a multi-center, observational study to assess the performance and safety of the CPNS System in patients with ADHF. 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
- 13 participants
- Where
- 6 sitesin 3 countries
- Study dates
- 10 May 2022to 12 Sep 2023
- 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 the hospital or planned to be admitted with a principal diagnosis of acute decompensated heart failure
- BMI adjusted BNP ≥ 500 pg/mL or NT-proBNP ≥ 2000 pg/mL
- LVEF ≤ 50%
- At least one sign/symptom of fluid overload
- At least one of the following:
- Inadequate diuretic response
- At least one sign or symptom of low perfusion
Who cannot join
- Received an inotrope during current hospitalization
- Requires mechanical support
- Cardiogenic shock or impending cardiogenic shock
- Multi-organ failure
- Systolic blood pressure < 80mmHg or > 140mmHg
- Symptomatic hypotension
- eGFR < 25 mL/min/1.732
- Severe hepatic disease
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
Hungary3 sites
Semmelweis University, Heart and Vascular Center
Budapest
Hearth Faculty of Medicine, University of Pécs
Pécs
Szegedi Tudományegyetem ÁOK
Szeged
Slovakia2 sites
Stredoslovenský Ústav srdcových a Cievnych Chorȏb, a.s.
Banská Bystrica, 97401
CINRE s.r.o
Bratislava
About this study
Official title: Cardiac Pulmonary Nerve STIMulation in Acute Decompensated Heart Failure
The STIM-ADHF Study is a multi-center, observational study to assess the performance and safety of the CPNS System in patients with ADHF.
Read the detailed description
The CPNS System is a neuromodulation system used to treat ADHF, a sudden or slow deterioration of chronic heart failure. The CPNS system is intended to provide acute (≤ 5 days) endovascular stimulation of the cardiac autonomic nerves in the right pulmonary artery (PA) in hospitalized ADHF patients. The system consists of an acute temporary neuromodulation stimulation catheter placed in the right pulmonary artery via venous access and a custom stimulator, denoiser, and associated cables. The CN2 Catheter is delivered to the right PA and provides an inotropic and/or lusitropic therapeutic effect by electrical stimulation to the terminal sympathetic nerve branches within the cardio-pulmonary plexus. The study will be conducted at up to 20 study sites worldwide. Up to 50 subjects who meet the eligibility criteria, will be enrolled, treated in-hospital with the Cardionomic CPNS System, monitored closely throughout the hospitalization and followed through 30 days post hospital discharge to evaluate the effect of the CPNS treatment.
- Conditions
- Acute Decompensated Heart Failure
- Being tested
- CPNS Therapy
- 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
| Study group | Role | What they receive |
|---|---|---|
| CPNS Therapy | Experimental | Endovascular stimulation of the cardiac autonomic nerves in addition to standard of care. Receives: Device: CPNS Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of related adverse events
The following measures will be characterized in all enrolled subjects: occurrence of all procedure, device and therapy related adverse events, serious adverse events and deaths
Measured: Enrolment to 30 Days post hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2022
- Study start10 May 2022
- Primary completion12 Sep 2023
- Study completion12 Sep 2023
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 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
- NCT05313438
- Sponsor's protocol ID
- CLN-1108-001
- Status last verified
- Nov 2023
- First submitted
- 29 Mar 2022
- Last updated
- 8 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Pulmonary Nerve STIMulation in Acute Decompensated Heart Failure
- ClinicalTrials.gov ID
- NCT05313438
- Acronym / sponsor ID
- CLN-1108-001
- Conditions
- Acute Decompensated Heart Failure
- Keywords
- Neurostimulation, Contractility, Right Pulmonary Artery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Cardionomic Inc.Industry (pharma, biotech, devices)
- Study start
- 10 May 2022 (actual)
- Primary completion
- 12 Sep 2023 (actual)
- Study completion
- 12 Sep 2023 (actual)
- First posted
- 6 Apr 2022 (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.
The STIM-ADHF Study is a multi-center, observational study to assess the performance and safety of the CPNS System in patients with ADHF.
Detailed description
The CPNS System is a neuromodulation system used to treat ADHF, a sudden or slow deterioration of chronic heart failure. The CPNS system is intended to provide acute (≤ 5 days) endovascular stimulation of the cardiac autonomic nerves in the right pulmonary artery (PA) in hospitalized ADHF patients. The system consists of an acute temporary neuromodulation stimulation catheter placed in the right pulmonary artery via venous access and a custom stimulator, denoiser, and associated cables. The CN2 Catheter is delivered to the right PA and provides an inotropic and/or lusitropic therapeutic effect by electrical stimulation to the terminal sympathetic nerve branches within the cardio-pulmonary plexus. The study will be conducted at up to 20 study sites worldwide. Up to 50 subjects who meet the eligibility criteria, will be enrolled, treated in-hospital with the Cardionomic CPNS System, monitored closely throughout the hospitalization and followed through 30 days post hospital discharge to evaluate the effect of the CPNS treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CPNS Therapy | Experimental | Device: CPNS TherapyEndovascular stimulation of the cardiac autonomic nerves in addition to standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Admitted to the hospital or planned to be admitted with a principal diagnosis of acute decompensated heart failure
- BMI adjusted BNP ≥ 500 pg/mL or NT-proBNP ≥ 2000 pg/mL
- LVEF ≤ 50%
- At least one sign/symptom of fluid overload
- At least one of the following:
Key exclusion criteria (8 listed)
- Received an inotrope during current hospitalization
- Requires mechanical support
- Cardiogenic shock or impending cardiogenic shock
- Multi-organ failure
- Systolic blood pressure < 80mmHg or > 140mmHg
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 |
Primary outcome
Occurrence of related adverse events
Time frame: Enrolment to 30 Days post hospital discharge
The following measures will be characterized in all enrolled subjects: occurrence of all procedure, device and therapy related adverse events, 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 8 Nov 2023.
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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.
6 sites in 3 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 6 sites in 3 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 7 inclusion and 8 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 8 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Hungary, Slovakia, Poland. 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?
Occurrence of related adverse events (time frame: Enrolment to 30 Days post hospital discharge). 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 8 Nov 2023.