CPNS Therapy for Heart Failure

Phase-Based Estimates
1
Effectiveness
1
Safety
Punta Pacifica, Panama City, Panama
Heart Failure+1 More
CPNS Therapy - Device
Eligibility
18+
All Sexes
Eligible conditions
Heart Failure

Study Summary

This study is evaluating whether a new device can help people with heart failure.

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Eligible Conditions

  • Heart Failure
  • Acute Decompensated Heart Failure (ADHF)

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether CPNS Therapy will improve 1 primary outcome in patients with Heart Failure. Measurement will happen over the course of 6 months.

6 months
Safety Measures

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Control
CPNS Therapy

This trial requires 90 total participants across 2 different treatment groups

This trial involves 2 different treatments. CPNS Therapy is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

CPNS TherapyTreatment with CPNS system: Endovascular stimulation of the cardiac autonomic nerves in addition to standard of care
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 6 months for reporting.

Closest Location

Summa Health - Akron, OH

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 6 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
At least one sign/symptom of fluid overload
LVEF ≤ 45%
Admitted to hospital with a principal diagnosis of ADHF
BMI adjusted BNP ≥ 500 pg/mL or NT-proBNP ≥ 2000 pg/mL
inadequate diuretic response
least one sign or symptom of low perfusion

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people get heart failure a year in the United States?

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The number of new cases of heart failure in all age groups is increasing, but the prevalence of heart failure remains low for all age groups.

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Can heart failure be cured?

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Heart failure is often caused by cardiomyopathy, which is often in turn caused by coronary atherosclerosis. After successful treatment of the cardiac disease, recovery of heart function often does not happen until some time has passed.

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What are the signs of heart failure?

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The physical examination by a physician can help identify the cardinal signs of heart failure. These signs can be evaluated objectively and help establish the diagnosis of heart failure and guide treatment.\n

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What are common treatments for heart failure?

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Common treatments for HF depend on a number of variables, including the cause and severity of HF, comorbid conditions, and severity of symptoms. Ventricular assist device for patients with end-stage HF, combined with heart transplant for select patients, is an option. Transplant rejection in HF can be prevented by corticosteroid"

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What causes heart failure?

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In the US heart failure is the leading cause of hospitalization in men of Medicare age and accounts for a major portion of the use of hospital resource. The cost and public interest in heart failure management can be optimized by reducing the use of hospitalization and prolonged intensive care.

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What is heart failure?

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Heart failure may be defined as the abnormal cardiac function that is accompanied by signs and symptoms. It is most common in people age 60 or over, but may be noticed in younger and older people. Symptoms vary greatly among people with heart failure and may be nonspecific when it is first noticed. The symptoms most reliably suggest a diagnosis of heart failure; and most are the result of fluid overload.\n

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What does cpns therapy usually treat?

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These patients are usually not candidates for surgery. On the other hand, they are often candidates for the combined approach of biventricular pacing and right ventricular support. Results from a recent paper of this therapy have often been very satisfying. Unfortunately, such a combined approach requires an advanced level of expertise and cooperation of the interventional cardiologist and the cardiology ward where such patients are taken care of. There are hardly any guidelines in the literature in question. In order to provide this high level of care to this large class of patients, a multidisciplinary approach should be adopted.

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Is cpns therapy safe for people?

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The authors' results suggest that cpns is effective in preventing the development of heart failure in the short run and, therefore, it should be included in the treatment of patients with type 2 diabetes. However, a short-term cpns therapy is not as effective as, and does not induce as significant changes, in heart rate recovery.

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Has cpns therapy proven to be more effective than a placebo?

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This is the first study that shows that chronic treatment with CPNS is more effective for HRF compared to placebo, in a group of HRF patients who were mostly in clinical deterioration. These observations should motivate further studies, in order to confirm our findings and to improve our HRF management.

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How serious can heart failure be?

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The seriousness of heart failure depends on several patient-related factors and on the heart's capacity to pump blood effectively. One must be aware of the signs and symptoms, the extent of the heart damage (symptoms and physical signs of heart failure such as dizziness and sweating), the degree of exertion prior to deterioration, and how rapidly the deterioration becomes severe. Patients with heart failure who are well enough to walk a short distance or to engage in light activities prior to worsening are better able to deal with worsening heart failure. A prognosis model may be used in the first visit of the patient with heart failure to assess the seriousness of the case. Once heart failure begins to deteriorate suddenly, it is impossible to save anything but life.

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What is the latest research for heart failure?

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There can be many causes for heart failure and the most common being hypertrophic cardiomyopathy, dilated cardiomyopathy, left ventricular non-compaction, ischemic cardiomyopathy, right ventricular cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, cardiomyopathy, restrictive cardiomyopathy and some types of familial hypertrophy. In this research article we have reviewed the latest findings, from a clinical perspective, for Heart Failure, both the causes and treatment options from a patient's personal perspective.

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How does cpns therapy work?

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The data suggest that cpns treatment offers a good option for the treatment of congestive heart failure with and without LV dysfunction when in addition to beta-blockers the CPNS is used.

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