NYHA Class III Heart FailureNCT02857231
Bioimpedance Spectroscopy Compared to CardioMEMS™
An observational study of NYHA Class III Heart Failure, run by ImpediMed Limited at 1 site in United States.
Trial summary
Comparison of changes in diastolic pulmonary artery pressure as measured by CardioMEMS™ to impedance parameters as measured by ImpediMed's BIS technology. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NYHA Class III Heart Failure
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Aug 2017to 9 Oct 2018
- Phase
- Observational
- 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
Study population: Heart failure patients who have a CardioMEMS device
Who may be able to join
- Patient:
- has an CardioMEMs device implanted
- has been diagnosed with various stages of heart failure as described by New York Heart Association (NYHA)
- is able to give informed consent
Who cannot join
- Patient:
- has pacemaker/ICD
- is pregnant or breastfeeding
- is an amputee
- has been diagnosed with multiple medical conditions that would make participation burdensome
- not able to co-operate with impedance measurements
Trial locations and contacts
1 site in 1 country.
United States1 site
Scripps Clinic, John R. Anderson V Medical Pavilion
La Jolla, California, 92037
About this study
Official title: Bioimpedance Spectroscopy Compared to CardioMEMS™ Determined Pulmonary Artery Pressure Measurements
Comparison of changes in diastolic pulmonary artery pressure as measured by CardioMEMS™ to impedance parameters as measured by ImpediMed's BIS technology.
Read the 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.
- Conditions
- NYHA Class III Heart Failure
- Keywords
- Bioimpedance spectroscopy
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in bioimpedance measurement at 4 weeks
Change in impedance values will be tracked from baseline for 4 weeks and compared to CardioMEMS measures
Measured: Baseline and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2016 (estimated)
- Study start7 Aug 2017
- Primary completion19 Mar 2018
- Study completion9 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NYHA Class III 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- ImpediMed Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- James T Heywood, MD, Principal investigator, Scripps Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02857231
- Sponsor's protocol ID
- IPD-SCRIPPS-01
- Status last verified
- Jul 2019
- First submitted
- 27 Jul 2016
- Last updated
- 8 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: This is a pilot study, no individual participant data will be made available.
Publications
Accardi AJ, Matsubara BS, Gaw RL, Daleiden-Burns A, Heywood JT. Clinical Utility of Fluid Volume Assessment in Heart Failure Patients Using Bioimpedance Spectroscopy. Front Cardiovasc Med. 2021 Apr 7;8:636718. doi: 10.3389/fcvm.2021.636718. eCollection 2021.
PubMed 33898536
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioimpedance Spectroscopy Compared to CardioMEMS™ Determined Pulmonary Artery Pressure Measurements
- ClinicalTrials.gov ID
- NCT02857231
- Acronym / sponsor ID
- IPD-SCRIPPS-01
- Conditions
- NYHA Class III Heart Failure
- Keywords
- Bioimpedance spectroscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- ImpediMed LimitedIndustry (pharma, biotech, devices)
- Study start
- 7 Aug 2017 (actual)
- Primary completion
- 19 Mar 2018 (actual)
- Study completion
- 9 Oct 2018 (actual)
- First posted
- 5 Aug 2016 (estimated)
- 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Heart failure patients who have a CardioMEMS device
Key inclusion criteria (4 listed)
- has an CardioMEMs device implanted
- has been diagnosed with various stages of heart failure as described by New York Heart Association (NYHA)
- is able to give informed consent
Key exclusion criteria (6 listed)
- has pacemaker/ICD
- is pregnant or breastfeeding
- is an amputee
- has been diagnosed with multiple medical conditions that would make participation burdensome
- not able to co-operate with impedance measurements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change from baseline in bioimpedance measurement at 4 weeks
Time frame: Baseline and 4 weeks
Change in impedance values will be tracked from baseline for 4 weeks and compared to CardioMEMS measures
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 Jul 2019.
- Derived from this study: PubMed 33898536Accardi AJ, Matsubara BS, Gaw RL, Daleiden-Burns A, Heywood JT. Clinical Utility of Fluid Volume Assessment in Heart Failure Patients Using Bioimpedance Spectroscopy. Front Cardiovasc Med. 2021 Apr 7;8:636718. doi: 10.3389/fcvm.2021.636718. eCollection 2021.
- Individual participant dataSharing planned: No. This is a pilot study, no individual participant data will be made available.
Related trials for NYHA Class III Heart Failure
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Active, not recruiting
Neural Cardiac Therapy for Heart Failure Study (NECTAR-HF)
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Barostim-Enabled NEurohormonal Intervention For Improving Treatment of Heart Failure
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Not yet recruiting
Inspiratory Muscle Training in Hospitalized Patients With Heart Failure Awaiting Advanced Therapies
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Recruiting
NORM-HF Pivotal Study
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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.
James T Heywood, MD principal investigator
Scripps Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of NYHA Class III Heart Failure, run by ImpediMed Limited at 1 site in United States.
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 4 inclusion and 6 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 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Change from baseline in bioimpedance measurement at 4 weeks (time frame: Baseline and 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02857231, which also lists 1 linked publication.
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 Jul 2019.