Exercise Pulmonary Transit Time

• Sponsor: Vanderbilt University Medical Center (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04336995
• Collaborator: (none)
• Enrollment: 14
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 27.1
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 14 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: small pilot study to test technical feasibilitysmall 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: Aug 27, 2020
• Actual Primary Completion Date: Aug 25, 2021
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Pulmonary Transit Time [3-10 seconds]

   interval required for the pulmonary blood volume to traverse the pulmonary circulation

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VHVI	Nashville	Tennessee	United States	37232

Sponsors and Collaborators

• Vanderbilt University Medical Center

Investigators

• Principal Investigator: Ken Monahan, MD, VUMC

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Apr 1, 2020

More Information

Publications

None provided.

• Responsible Party: Ken Monahan, Assistant Professor of Medicine, Vanderbilt University Medical Center
• ClinicalTrials.gov Identifier: NCT04336995
• Other Study ID Numbers: IRB200429
• First Posted: Apr 7, 2020
• Last Update Posted: Jul 12, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Heart Failure, Diastolic

Study Results

Participant Flow

Arm/Group Title	Exercise
Arm/Group Description	Everyone is in this arm contrast echocardiography: giving echocardiographic contrast and taking echocardiographic images before and after exercise
Period Title: Overall Study
STARTED	14
COMPLETED	14
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Exercise
Arm/Group Description	Everyone is in this arm contrast echocardiography: giving echocardiographic contrast and taking echocardiographic images before and after exercise
Overall Participants	14
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	46 (8)
Sex: Female, Male (Count of Participants)
Female	2 14.3%
Male	12 85.7%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	1 7.1%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	13 92.9%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	14 100%

Outcome Measures

1. Primary Outcome

Title	Pulmonary Transit Time
Description	interval required for the pulmonary blood volume to traverse the pulmonary circulation
Time Frame	3-10 seconds

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Exercise
Arm/Group Description	Everyone is in this arm contrast echocardiography: giving echocardiographic contrast and taking echocardiographic images before and after exercise
Measure Participants	14
Mean (Standard Deviation) [seconds]	2.5 (0.5)

Adverse Events

Time Frame	day of study
Arm/Group Title	Exercise
Arm/Group Description	Everyone is in this arm contrast echocardiography: giving echocardiographic contrast and taking echocardiographic images before and after exercise
All Cause Mortality
	Exercise
	Affected / at Risk (%)	# Events
Total	0/14 (0%)
Serious Adverse Events
	Exercise
	Affected / at Risk (%)	# Events
Total	0/14 (0%)
Other (Not Including Serious) Adverse Events
	Exercise
	Affected / at Risk (%)	# Events
Total	0/14 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.