RECRUITING

Feasibility and Efficacy Study of the CardioPulmonary Management (CPM) System in Patients With Chronic Heart Failure ( BETA )

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Conditions

Heart Failure

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The primary purpose for this study is to support the hypothesis (pilot data) that the use of the CardioPumonary Management (CPM) system reduces the rate of heart failure (HF) related events and the related healthcare cost. The study will also measure the impact on quality of care and patient satisfaction. In order to support the primary objective, the study will compare the outcomes and costs for patients using the CPM system against those who are not. This can either be done using institutions averages, if available, or through a control group.

Official Title

Feasibility and Efficacy Study of the CardioPulmonary Management (CPM) System in Patients With Chronic Heart Failure

Quick Facts

Study Start:2023-09-22
Study Completion:2026-10-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06045117

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * New York Heart Association (NYHA) Class III-IV
  2. * NYHA Class II HF with one or more of the following:
  3. * Chronic Kidney Disease (eGFR\<60 within the past 6 months) (Estimated Glomerular Filtration Rate)
  4. * HF hospitalization (defined as HF listed as the major reason for hospitalization) within 9 months prior to screening visit and NT-proBNP (N-terminal pro b-type natriuretic peptide) \> 200 pg/ml for patients not in atrial fibrillation (AF) or \> 600 pg/m for patients in AF on screening ECG (electrocardiogram)
  5. * NT-proBNP \> 300 pg/ml for patients not in AF or \> 900 pg/ml for patients in AF on the screening visit ECG.
  6. * Chronic obstructive pulmonary disease (COPD)
  1. * Under 18 years of age
  2. * Patients with severe COPD (GOLD stage III or IV)
  3. * Limited mobility preventing application of device
  4. * Cognitive impairments that would limit the application and proper use of the device
  5. * Skin allergies or skin sensitivities to silicone-based adhesives
  6. * Pregnancy
  7. * Skin breakdown on the left chest or breast area
  8. * Not willing to shave chest hair if needed to apply device
  9. * Patients on chronic ionotropic therapy
  10. * Patients with any condition that might limit the survival to less than 1 year as assessed by the investigator
  11. * No cellular coverage (Patient's Home)

Contacts and Locations

Study Contact

Emily Wycallis
CONTACT
9784351644
emily.wycallis@analog.com

Study Locations (Sites)

Cone Health
Greensboro, North Carolina, 27401
United States

Collaborators and Investigators

Sponsor: Analog Device, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-22
Study Completion Date2026-10-01

Study Record Updates

Study Start Date2023-09-22
Study Completion Date2026-10-01

Terms related to this study

Additional Relevant MeSH Terms

  • Heart Failure