Congestive Heart FailureNCT03535909
Hemodynamic Assessment in Acute Decompensated Heart Failure
An observational study of Congestive Heart Failure, run by Rodin Scientific LLC at 2 sites in 2 countries.
Trial summary
This study will assess the ability of a novel optical measurement system to determine changes in the hemodynamic status of heart failure patients admitted to the hospital with a primary diagnosis of acute decompensated heart failure. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Congestive Heart Failure
- What is being tested?
- Noninvasive Hemodynamic Measurement System
- How many people
- 5 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 9 Jun 2018to 31 Jul 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects diagnosed with congestive heart failure and admitted to the hospital with a diagnosis of acute decompensated heart failure (ADHF).
Who may be able to join
- Age ≥ 18 years
- Admission to the hospital with a primary diagnosis of acute decompensated heart failure
- Treated with or planned treatment with intravenous diuretics
- Volume overload, as indicated by at least one of the following clinical signs:
- Peripheral edema
- Pulmonary edema on physical examination
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- Pleural effusions on chest x-ray
- Jugular venous distension on physical examination
- CVP > 10 cmH2O
- Presence of third heart sound
- Able to understand study procedures, agree to participate in the study program and voluntarily provide written informed consent
Who cannot join
- Inability or refusal to sign the Subject Informed Consent
- Age > 80 years
- Body mass index (BMI) > 40
- Planned mechanical ventilation during hospitalization
- Presence of left ventricular assist device (LVAD)
- Dialysis
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- Pregnancy. All women of childbearing potential must have a negative pregnancy test before enrollment.
- Parenteral diuretic or other medical treatment for ADHF already administered for more than 12 hours prior to enrollment
- Skin damage to the optical sampling sites (fingers and dorsal hand), to include tattoos, scars, cuts, or burns extending over more than 30% of the visible tissue
- Compromised superficial hand veins or proximal venous stenosis
- Intravenous lines connected to both arms
- Inability to stand with support, if needed, for 4 minutes
- Inability to place hand in the venous imaging enclosure due to forearm, elbow, or shoulder injuries, or other physical constraints
- Inability to wear fingertip or ring sensors on three fingers (of either hand) due to missing fingers, injured fingers, or other physical constraints
- Persons in police custody or prisoners
- Major medical or psychiatric condition that would interfere with the ability to complete the study
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
New Mexico Heart Institute
Albuquerque, New Mexico, 87102
About this study
Official title: Hemodynamic Assessment Throughout Diuretic Treatment in Acute Decompensated Heart Failure
This study will assess the ability of a novel optical measurement system to determine changes in the hemodynamic status of heart failure patients admitted to the hospital with a primary diagnosis of acute decompensated heart failure. Patients will be measured with both the novel measurement system and reference devices that are FDA-cleared for hemodynamic measurements. The measurements from the novel system will be compared to reference variables describing hemodynamic and congestive status, including stroke volume, central venous pressure, and serum levels of NT-proBNP.
Read the detailed description
This study will assess the ability of a novel optical measurement system to determine changes in the hemodynamic status of heart failure patients admitted to the hospital with a primary diagnosis of acute decompensated heart failure. Patients will be measured with both the novel measurement system and reference devices that are FDA-cleared for hemodynamic measurements. The measurements from the novel system will be compared to reference variables describing hemodynamic and congestive status, including stroke volume, central venous pressure, and serum levels of NT-proBNP.
All patients enrolled in the study will first provide written informed consent to participate and then the research coordinator will check that the subject meets all study inclusion criteria and does not meet any of the study exclusion criteria. Enrolled subjects will undergo up to six (6) hemodynamic assessment sessions lasting less than 90 minutes each over the course of their hospitalization. There will be at least eight (8) hours between assessment sessions.
Each assessment session includes recording of the subject's weight, measurements with the reference devices, and measurements with the novel optical system. During the session, the subject will be assessed in the supine, sitting, and standing positions. NT-proBNP measurements will be done at the start of study participation and the end. A market research questionnaire will be administered to the subject following the first measurement session.
- Conditions
- Congestive Heart Failure
- Being tested
- Noninvasive Hemodynamic Measurement System
- Keywords
- CHF, central venous pressure, noninvasive, ADHF, stroke volume
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Noninvasive Hemodynamic Measurement SystemDiagnostic test
Ability of the noninvasive hemodynamic measurement system to determine changes in the hemodynamic status of heart failure patients admitted to the hospital with a primary diagnosis of acute decompensated heart failure.
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of Estimated Changes in Stroke Volume
Comparison of Stroke Volume Measurement (units of ml) from the optical measurement system with paired Stroke Volume Measurement (ml) from the reference device. Accuracy will be measured in percentage error and Bland-Altman limits of agreement.
Measured: Retrospective up to 6 months after study completion
Secondary outcomes (1)
Accuracy of Central Venous Pressure Measurement
Comparison of Central Venous Pressure Measurement (units of cmH2O) from the optical measurement system with paired Central Venous Pressure Measurement (cmH2O) from the reference device. Accuracy will be measured in percentage error and Bland-Altman limits of agreement.
Measured: Retrospective up to 6 months after study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2018
- Study start9 Jun 2018
- Primary completion24 Jun 2018
- Study completion31 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congestive 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
- Cross-sectional
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rodin Scientific LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Split, School of Medicine
- Responsible party
- Sponsor
- Investigators
- Elena Allen, PhD, Principal investigator, Rodin Scientific
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03535909
- Sponsor's protocol ID
- RS-2018-S01
- Status last verified
- Mar 2019
- First submitted
- 16 Apr 2018
- Last updated
- 26 Mar 2019
- 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 26 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic Assessment Throughout Diuretic Treatment in Acute Decompensated Heart Failure
- ClinicalTrials.gov ID
- NCT03535909
- Acronym / sponsor ID
- RS-2018-S01
- Conditions
- Congestive Heart Failure
- Keywords
- CHF, central venous pressure, noninvasive, ADHF, stroke volume
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Rodin Scientific LLCIndustry (pharma, biotech, devices)
- Collaborators
- University of Split, School of Medicine
- Study start
- 9 Jun 2018 (actual)
- Primary completion
- 24 Jun 2018 (actual)
- Study completion
- 31 Jul 2018 (actual)
- First posted
- 24 May 2018 (actual)
- 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.
This study will assess the ability of a novel optical measurement system to determine changes in the hemodynamic status of heart failure patients admitted to the hospital with a primary diagnosis of acute decompensated heart failure. Patients will be measured with both the novel measurement system and reference devices that are FDA-cleared for hemodynamic measurements. The measurements from the novel system will be compared to reference variables describing hemodynamic and congestive status, including stroke volume, central venous pressure, and serum levels of NT-proBNP.
Detailed description
This study will assess the ability of a novel optical measurement system to determine changes in the hemodynamic status of heart failure patients admitted to the hospital with a primary diagnosis of acute decompensated heart failure. Patients will be measured with both the novel measurement system and reference devices that are FDA-cleared for hemodynamic measurements. The measurements from the novel system will be compared to reference variables describing hemodynamic and congestive status, including stroke volume, central venous pressure, and serum levels of NT-proBNP.
All patients enrolled in the study will first provide written informed consent to participate and then the research coordinator will check that the subject meets all study inclusion criteria and does not meet any of the study exclusion criteria. Enrolled subjects will undergo up to six (6) hemodynamic assessment sessions lasting less than 90 minutes each over the course of their hospitalization. There will be at least eight (8) hours between assessment sessions.
Each assessment session includes recording of the subject's weight, measurements with the reference devices, and measurements with the novel optical system. During the session, the subject will be assessed in the supine, sitting, and standing positions. NT-proBNP measurements will be done at the start of study participation and the end. A market research questionnaire will be administered to the subject following the first measurement session.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects diagnosed with congestive heart failure and admitted to the hospital with a diagnosis of acute decompensated heart failure (ADHF).
Key inclusion criteria (11 listed)
- Age ≥ 18 years
- Admission to the hospital with a primary diagnosis of acute decompensated heart failure
- Treated with or planned treatment with intravenous diuretics
- Volume overload, as indicated by at least one of the following clinical signs:
- Able to understand study procedures, agree to participate in the study program and voluntarily provide written informed consent
Key exclusion criteria (16 listed)
- Inability or refusal to sign the Subject Informed Consent
- Age > 80 years
- Body mass index (BMI) > 40
- Planned mechanical ventilation during hospitalization
- Presence of left ventricular assist device (LVAD)
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 |
|---|---|---|
| Noninvasive Hemodynamic Measurement SystemAbility of the noninvasive hemodynamic measurement system to determine changes in the hemodynamic status of heart failure patients admitted to the hospital with a primary diagnosis of acute decompensated heart failure. | Diagnostic test | – |
Primary outcome
Accuracy of Estimated Changes in Stroke Volume
Time frame: Retrospective up to 6 months after study completion
Comparison of Stroke Volume Measurement (units of ml) from the optical measurement system with paired Stroke Volume Measurement (ml) from the reference device. Accuracy will be measured in percentage error and Bland-Altman limits of agreement.
1 secondary outcome
Accuracy of Central Venous Pressure Measurement
Time frame: Retrospective up to 6 months after study completion
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 26 Mar 2019.
- 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.
Elena Allen, PhD principal investigator
Rodin Scientific
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congestive Heart Failure, run by Rodin Scientific LLC at 2 sites in 2 countries.
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 11 inclusion and 16 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 26 Mar 2019. 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, Croatia. 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?
Accuracy of Estimated Changes in Stroke Volume (time frame: Retrospective up to 6 months after study completion). 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 26 Mar 2019.