Exercise Pulmonary Transit Time
Primary Purpose
Heart Failure, Diastolic
Status
Active
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
contrast echocardiography
Sponsored by
About this trial
This is an interventional diagnostic trial for Heart Failure, Diastolic
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 18 years old
- Able to give informed consent
Exclusion Criteria:
- Known allergic reaction to Definity or Optison ultrasound contrast
- Pregnancy/Nursing - as assessed/disclosed by the participant
Sites / Locations
- VHVI
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Exercise
Arm Description
Everyone is in this arm
Outcomes
Primary Outcome Measures
Pulmonary Transit Time
interval required for the pulmonary blood volume to traverse the pulmonary circulation
Secondary Outcome Measures
Full Information
NCT ID
NCT04336995
First Posted
April 3, 2020
Last Updated
March 20, 2023
Sponsor
Vanderbilt University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT04336995
Brief Title
Exercise Pulmonary Transit Time
Official Title
Echocardiographic Assessment of Pulmonary Transit Time Following Exercise
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 27, 2020 (Actual)
Primary Completion Date
August 25, 2021 (Actual)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Diastolic
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
small pilot study to test technical feasibility
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exercise
Arm Type
Other
Arm Description
Everyone is in this arm
Intervention Type
Diagnostic Test
Intervention Name(s)
contrast echocardiography
Intervention Description
giving echocardiographic contrast and taking echocardiographic images before and after exercise
Primary Outcome Measure Information:
Title
Pulmonary Transit Time
Description
interval required for the pulmonary blood volume to traverse the pulmonary circulation
Time Frame
3-10 seconds
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age ≥ 18 years old
Able to give informed consent
Exclusion Criteria:
Known allergic reaction to Definity or Optison ultrasound contrast
Pregnancy/Nursing - as assessed/disclosed by the participant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ken Monahan, MD
Organizational Affiliation
VUMC
Official's Role
Principal Investigator
Facility Information:
Facility Name
VHVI
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Exercise Pulmonary Transit Time
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