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Exercise Pulmonary Transit Time

NCT ID: NCT04336995

Last Updated: 2024-04-09

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-27

Study Completion Date

2024-03-01

Brief Summary

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

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Detailed Description

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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

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Heart Failure, Diastolic

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

small pilot study to test technical feasibility
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Exercise

Everyone is in this arm

Group Type OTHER

contrast echocardiography

Intervention Type DIAGNOSTIC_TEST

giving echocardiographic contrast and taking echocardiographic images before and after exercise

Interventions

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contrast echocardiography

giving echocardiographic contrast and taking echocardiographic images before and after exercise

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Vanderbilt University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Ken Monahan

Assistant Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ken Monahan, MD

Role: PRINCIPAL_INVESTIGATOR

VUMC

Locations

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VHVI

Nashville, Tennessee, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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IRB200429

Identifier Type: -

Identifier Source: org_study_id

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