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Cardiac Device
CPNS Device Therapy for Heart Failure
N/A
Waitlist Available
Research Sponsored by Cardionomic Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Study Summary
This trial is testing a new device to help people with heart failure. The device is placed under the skin and sends electrical pulses to the heart to help it pump better.
Who is the study for?
This trial is for adults hospitalized with acute decompensated heart failure, having a certain level of BNP or NT-proBNP (heart stress markers), and reduced heart function (LVEF ≤ 50%). They should have signs of fluid overload despite diuretic treatment. It's not for those with very low kidney function, severe low blood pressure, recent high-dose inotrope use, mechanical support needs, or extreme blood pressure levels.Check my eligibility
What is being tested?
The study tests the Cardionomic CPNS system against standard care in patients with acute decompensated heart failure. The CPNS system aims to improve cardiac response by stimulating nerves that influence heart and lung function.See study design
What are the potential side effects?
While specific side effects are not listed here, similar nerve stimulation therapies can cause discomfort at the stimulation site, changes in blood pressure or heartbeat rate, headache, throat irritation or muscle twitching.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety Measures
Trial Design
2Treatment groups
Experimental Treatment
Group I: Standard of CareExperimental Treatment1 Intervention
Available standard treatment
Group II: CPNS TherapyExperimental Treatment2 Interventions
Treatment with CPNS system: Endovascular stimulation of the cardiac autonomic nerves in addition to standard of care
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CPNS Therapy
2021
N/A
~80
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Who is running the clinical trial?
Cardionomic Inc.Lead Sponsor
1 Previous Clinical Trials
13 Total Patients Enrolled
1 Trials studying Heart Failure
13 Patients Enrolled for Heart Failure
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Eligibility Criteria:
This trial includes the following eligibility criteria:- Your blood test shows a high level of a substance called BNP or NT-proBNP.Your heart's pumping ability is below a certain level.Your kidney function is severely reduced, with an eGFR less than 25 mL/min/1.732.You have received strong heart medication or a specific kind of heart medication within a certain time frame before joining the study.Needs a machine to help with bodily functions.You were admitted to the hospital with a main diagnosis of acute decompensated heart failure.You have signs or symptoms of too much fluid in your body, even after getting a specific medication through an IV.You have a severe heart condition that could lead to shock.Your blood pressure is too low (less than 80mmHg) or too high (more than 140mmHg).You have low blood pressure and are experiencing symptoms from it.
Research Study Groups:
This trial has the following groups:- Group 1: Standard of Care
- Group 2: CPNS Therapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many people have been enlisted for this clinical experiment?
"Correct. Per clinicaltrials.gov, this study is actively seeking participants with its post date of April 12th 2021 and most recent update on September 26th 2022. The trial necessitates the recruitment of 90 patients from nine separate hospitals/clinics."
Answered by AI
Are individuals still being recruited for participation in this trial?
"Affirmative. Per the information available on clinicaltrials.gov, this research endeavor is actively recruiting participants as of today. It was first posted in April 2021 and subsequently updated in September 2022; seeking to onboard 90 patients at 9 different medical sites."
Answered by AI
How many sites are hosting this clinical trial?
"Nine medical centres are currently authorized to participate in this research, including Oklahoma Heart Hospital South, The Christ Hospital and St. Vincent's Hospital; the full list can be found online."
Answered by AI
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