Heart Failure, DiastolicPhase 4NCT04336995
Exercise Pulmonary Transit Time
A Phase 4 study testing contrast echocardiography in people with Heart Failure, Diastolic, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
The study seeks to measure pulmonary transit time via contrast-echocardiography before and after exercise. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Failure, Diastolic
- What is being tested?
- contrast echocardiography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Aug 2020to 1 Mar 2024
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old
- Able to give informed consent
Who cannot join
- Known allergic reaction to Definity or Optison ultrasound contrast
- Pregnancy/Nursing - as assessed/disclosed by the participant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Echocardiographic Assessment of Pulmonary Transit Time Following Exercise
The study seeks to measure pulmonary transit time via contrast-echocardiography before and after exercise.
Read the detailed description
The ability to measure the amount of blood in the lungs using heart-ultrasound (echocardiography) can be useful to estimate how much fluid is in a patient's circulation, which can influence diagnosis and treatment of certain types of heart failure. In some patients, the amount of fluid is normal at rest, but can increase with activity and thus a diagnosis of heart failure can only be made after exercising. Currently, the amount of fluid is measured invasively. We have shown that echocardiography can measure the amount of fluid in the lung circulation at rest without the need for an invasive procedure. We now seek to find out if we can make a similar measurement after exercise. If successful, the need for catheter procedures may be reduced in certain types of heart failure.
- Conditions
- Heart Failure, Diastolic
- Being tested
- contrast echocardiography
- Medical subject headings
- Heart Failure, Diastolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
contrast echocardiographyDiagnostic test
giving echocardiographic contrast and taking echocardiographic images before and after exercise
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Other | Everyone is in this arm Receives: Diagnostic Test: contrast echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary Transit Time
interval required for the pulmonary blood volume to traverse the pulmonary circulation
Measured: 3-10 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2020
- Study start27 Aug 2020
- Primary completion25 Aug 2021
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Heart Failure, DiastolicStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- small pilot study to test technical feasibility
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ken Monahan, Vanderbilt University Medical Center
- Investigators
- Ken Monahan, MD, Principal investigator, VUMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04336995
- Sponsor's protocol ID
- IRB200429
- Status last verified
- Apr 2024
- First submitted
- 3 Apr 2020
- Last updated
- 9 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Echocardiographic Assessment of Pulmonary Transit Time Following Exercise
- ClinicalTrials.gov ID
- NCT04336995
- Acronym / sponsor ID
- IRB200429
- Conditions
- Heart Failure, Diastolic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 27 Aug 2020 (actual)
- Primary completion
- 25 Aug 2021 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 7 Apr 2020 (actual)
- Results
- Posted 12 Jul 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study seeks to measure pulmonary transit time via contrast-echocardiography before and after exercise.
Detailed description
The ability to measure the amount of blood in the lungs using heart-ultrasound (echocardiography) can be useful to estimate how much fluid is in a patient's circulation, which can influence diagnosis and treatment of certain types of heart failure. In some patients, the amount of fluid is normal at rest, but can increase with activity and thus a diagnosis of heart failure can only be made after exercising. Currently, the amount of fluid is measured invasively. We have shown that echocardiography can measure the amount of fluid in the lung circulation at rest without the need for an invasive procedure. We now seek to find out if we can make a similar measurement after exercise. If successful, the need for catheter procedures may be reduced in certain types of heart failure.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- small pilot study to test technical feasibility
| Arm | Type | Receives |
|---|---|---|
| Exercise | Other | Diagnostic Test: contrast echocardiographyEveryone is in this arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥ 18 years old
- Able to give informed consent
Key exclusion criteria (2 listed)
- Known allergic reaction to Definity or Optison ultrasound contrast
- Pregnancy/Nursing - as assessed/disclosed by the participant
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 |
|---|---|---|
| contrast echocardiographygiving echocardiographic contrast and taking echocardiographic images before and after exercise | Diagnostic test | Exercise |
Primary outcome
Pulmonary Transit Time
Time frame: 3-10 seconds
interval required for the pulmonary blood volume to traverse the pulmonary circulation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Ken Monahan, MD principal investigator
VUMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing contrast echocardiography in people with Heart Failure, Diastolic, run by Vanderbilt University Medical Center 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 2 inclusion and 2 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 9 Apr 2024. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Jul 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Pulmonary Transit Time (time frame: 3-10 seconds). 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 9 Apr 2024.