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Exercise Pulmonary Transit Time

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04336995
Recruitment Status : Active, not recruiting
First Posted : April 7, 2020
Results First Posted : July 12, 2022
Last Update Posted : July 12, 2022
Sponsor:
Information provided by (Responsible Party):
Ken Monahan, Vanderbilt University Medical Center

Brief Summary:
The study seeks to measure pulmonary transit time via contrast-echocardiography before and after exercise.

Condition or disease Intervention/treatment Phase
Heart Failure, Diastolic Diagnostic Test: contrast echocardiography Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: small pilot study to test technical feasibility
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Echocardiographic Assessment of Pulmonary Transit Time Following Exercise
Actual Study Start Date : August 27, 2020
Actual Primary Completion Date : August 25, 2021
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Exercise
Everyone is in this arm
Diagnostic Test: contrast echocardiography
giving echocardiographic contrast and taking echocardiographic images before and after exercise




Primary Outcome Measures :
  1. Pulmonary Transit Time [ Time Frame: 3-10 seconds ]
    interval required for the pulmonary blood volume to traverse the pulmonary circulation



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age ≥ 18 years old
  2. Able to give informed consent

Exclusion Criteria:

  1. Known allergic reaction to Definity or Optison ultrasound contrast
  2. Pregnancy/Nursing - as assessed/disclosed by the participant

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04336995


Locations
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United States, Tennessee
VHVI
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University Medical Center
Investigators
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Principal Investigator: Ken Monahan, MD VUMC
  Study Documents (Full-Text)

Documents provided by Ken Monahan, Vanderbilt University Medical Center:
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Responsible Party: Ken Monahan, Assistant Professor of Medicine, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT04336995    
Other Study ID Numbers: IRB200429
First Posted: April 7, 2020    Key Record Dates
Results First Posted: July 12, 2022
Last Update Posted: July 12, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Failure, Diastolic
Heart Failure
Heart Diseases
Cardiovascular Diseases