NYHA Class III Heart Failure
Conditions
Keywords
Bioimpedance spectroscopy
Brief summary
Comparison of changes in diastolic pulmonary artery pressure as measured by CardioMEMS™ to impedance parameters as measured by ImpediMed's BIS technology.
Detailed description
This is a prospective, single-arm, observational, non-randomized clinical study that will enroll patients with heart failure who have had a CardioMEMS™ device implanted to monitor their diastolic pulmonary artery pressure. The study will recruit and enroll ten participants from the Scripps Clinic. Participants will be monitored 3 times a week for a period of 4 weeks. At each monitoring visit, the patient's diastolic pulmonary artery pressure will be measured by CardioMEMS™ and the ImpediMed's BIS technology. Participant's vital signs and weight will also be taken at each monitoring visit.
Interventions
None listed
Sponsors
ImpediMed Limited
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patient: 1. has an CardioMEMs device implanted 2. has been diagnosed with various stages of heart failure as described by New York Heart Association (NYHA) 3. is able to give informed consent
Exclusion criteria
Patient: 1. has pacemaker/ICD 2. is pregnant or breastfeeding 3. is an amputee 4. has been diagnosed with multiple medical conditions that would make participation burdensome 5. not able to co-operate with impedance measurements
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in bioimpedance measurement at 4 weeks | Baseline and 4 weeks | Change in impedance values will be tracked from baseline for 4 weeks and compared to CardioMEMS measures |
Countries
United States
Outcome results
None listed