Heart FailureNCT02950597
Clinical Impact of Non-invasive Hemodynamic Monitoring
An observational study of Heart Failure, run by Loma Linda University at 2 sites in United States.
Trial summary
Study Details What is the study design? (eg, randomized, double-blind) Observational Prospective Study What are the overall objectives of the study? This project is designed to assess the feasibility of using a non-invasive hemodynamic monitoring device in heart failure outpatient clinics. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heart Failure
- What is being tested?
- Observational Study to Evaluate Utility of Non-invasive Hemodynamic Monitoring
- Type of treatment
- Medical device
- How many people
- 70 participants
- Where
- 2 sitesUnited States
- Study dates
- 19 Sep 2016to 19 Nov 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients enrolled in the study will include those who are classified as New York Heart Association (NYHA) Functional Classification of three or greater
Who may be able to join
- Patients seen in Loma Linda heart failure clinics classified as New York Heart Association (NYHA) Functional Classification of 3 or greater.
Who cannot join
- Age < 18 years of age,
- pregnancy,
- known severe peripheral artery disease,
- poor perfusion to fingers (as defined as a perfusion index less than 0.5%- www.Masimo.com),
- history of Raynaud's,
- refusal to provide written consent.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Loma Linda University Department of Anesthesiology
Loma Linda, California, 92354
Pat Moore
Loma Linda, California, 92354
About this study
Official title: Evaluation of Clinical Impact of Non-Invasive Hemodynamic Monitoring to Optimize Preventative Care of Heart Failure Patients
Study Details
What is the study design? (eg, randomized, double-blind) Observational Prospective Study
Read more
What are the overall objectives of the study? This project is designed to assess the feasibility of using a non-invasive hemodynamic monitoring device in heart failure outpatient clinics. There will be no alteration to patient management for this study. Rather this study seeks to assess the utility of the device by evaluating for the parameters obtained from the device to hospital admission.
How your research will contribute to the advancement of scientific knowledge?
☒This study will confirm/strengthen existing knowledge. ☒This study will test a completely novel hypothesis. ☒This study will explore novel endpoints. ☐Other [please describe]:
Read the detailed description
- BACKGROUND:
Nearly five million Americans experience heart failure (HF) and greater than 250,000 die annually. 1 The prevalence has continued to increase with the aging of the US population and HF is now the leading cause of hospitalization among adults >65 in the United states. Despite remarkable improvements in medical therapy, the prognosis of patients with myocardial failure remains poor, with almost 20% of patients dying within 1 year of initial diagnosis and > 80% 8-year mortality. 2 In addition patients who are admitted to the hospital for heart failure have over a 50% readmission rate within six months of discharge. 3,4 These patients require routine clinical care and often require diagnostic and therapeutic procedures. This project seeks to assess if the use of hemodynamic (HD) monitoring technologies (ClearSight/Nexfin) that are currently used in the intraoperative and critical care settings can provide utility by demonstrating associations between alterations in a patients HD values to the likelihood of hospital admission.
The non-invasive HD device utilized (Nexfin, Edwards Lifesciences, Irvine, CA) provided flow-guided cardiovascular parameters that were captured for each clinic visit for up to 24 months. Analysis was performed between the most recent prior clinic visits for patients who were hospitalized for HF exacerbation to those who were not hospitalized. HD data was not used to guide clinical care. A Cox hazard model using a log transformation of HD variables as the covariates, was applied to describe hospital admission.
- Conditions
- Heart Failure
- Being tested
- Observational Study to Evaluate Utility of Non-invasive Hemodynamic Monitoring
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational Study to Evaluate Utility of Non-invasive Hemodynamic MonitoringDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
associations between alteration of HD values to hospital admission
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2016 (estimated)
- Study start19 Sep 2016
- Primary completion19 Nov 2019
- Study completion19 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe sponsor's other registered studies.
- 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
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Davinder Ramsingh, MD, Loma Linda University
- Investigators
- Davinder Ramsingh, MD, Principal investigator, Loma Linda University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02950597
- Sponsor's protocol ID
- 5160245
- Status last verified
- Jul 2020
- First submitted
- 10 Oct 2016
- Last updated
- 30 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Clinical Impact of Non-Invasive Hemodynamic Monitoring to Optimize Preventative Care of Heart Failure Patients
- ClinicalTrials.gov ID
- NCT02950597
- Acronym / sponsor ID
- 5160245
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- 19 Sep 2016 (actual)
- Primary completion
- 19 Nov 2019 (actual)
- Study completion
- 19 Nov 2019 (actual)
- First posted
- 1 Nov 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.
Study Details
What is the study design? (eg, randomized, double-blind) Observational Prospective Study
What are the overall objectives of the study? This project is designed to assess the feasibility of using a non-invasive hemodynamic monitoring device in heart failure outpatient clinics. There will be no alteration to patient management for this study. Rather this study seeks to assess the utility of the device by evaluating for the parameters obtained from the device to hospital admission.
How your research will contribute to the advancement of scientific knowledge?
☒This study will confirm/strengthen existing knowledge. ☒This study will test a completely novel hypothesis. ☒This study will explore novel endpoints. ☐Other [please describe]:
Detailed description
- BACKGROUND:
Nearly five million Americans experience heart failure (HF) and greater than 250,000 die annually. 1 The prevalence has continued to increase with the aging of the US population and HF is now the leading cause of hospitalization among adults >65 in the United states. Despite remarkable improvements in medical therapy, the prognosis of patients with myocardial failure remains poor, with almost 20% of patients dying within 1 year of initial diagnosis and > 80% 8-year mortality. 2 In addition patients who are admitted to the hospital for heart failure have over a 50% readmission rate within six months of discharge. 3,4 These patients require routine clinical care and often require diagnostic and therapeutic procedures. This project seeks to assess if the use of hemodynamic (HD) monitoring technologies (ClearSight/Nexfin) that are currently used in the intraoperative and critical care settings can provide utility by demonstrating associations between alterations in a patients HD values to the likelihood of hospital admission.
The non-invasive HD device utilized (Nexfin, Edwards Lifesciences, Irvine, CA) provided flow-guided cardiovascular parameters that were captured for each clinic visit for up to 24 months. Analysis was performed between the most recent prior clinic visits for patients who were hospitalized for HF exacerbation to those who were not hospitalized. HD data was not used to guide clinical care. A Cox hazard model using a log transformation of HD variables as the covariates, was applied to describe hospital admission.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients enrolled in the study will include those who are classified as New York Heart Association (NYHA) Functional Classification of three or greater
Key inclusion criteria (1 listed)
- Patients seen in Loma Linda heart failure clinics classified as New York Heart Association (NYHA) Functional Classification of 3 or greater.
Key exclusion criteria (6 listed)
- Age < 18 years of age,
- pregnancy,
- known severe peripheral artery disease,
- poor perfusion to fingers (as defined as a perfusion index less than 0.5%- www.Masimo.com),
- history of Raynaud's,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational Study to Evaluate Utility of Non-invasive Hemodynamic Monitoring | Device | – |
Primary outcome
associations between alteration of HD values to hospital admission
Time frame: 24 months
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 30 Jul 2020.
- Individual participant dataSharing planned: No
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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.
Davinder Ramsingh, MD principal investigator
Loma Linda University Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Loma Linda University at 2 sites 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 1 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 30 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
associations between alteration of HD values to hospital admission (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jul 2020.