NCT04336995

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Aug 2020

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 3, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 7, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

August 27, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 25, 2021

Completed
11 months until next milestone

Results Posted

Study results publicly available

July 12, 2022

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

April 9, 2024

Status Verified

April 1, 2024

Enrollment Period

12 months

First QC Date

April 3, 2020

Results QC Date

May 20, 2022

Last Update Submit

April 5, 2024

Conditions

Heart Failure, Diastolic

Outcome Measures

Primary Outcomes (1)

  • Pulmonary Transit Time

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

    3-10 seconds

Study Arms (1)

Exercise

OTHER

Everyone is in this arm

Diagnostic Test: contrast echocardiography

Interventions

contrast echocardiographyDIAGNOSTIC_TEST

giving echocardiographic contrast and taking echocardiographic images before and after exercise

Exercise

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years old
  • Able to give informed consent

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VHVI

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Heart Failure, Diastolic

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

Heart FailureHeart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiac Imaging TechniquesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisUltrasonographyHeart Function TestsDiagnostic Techniques, Cardiovascular

Results Point of Contact

Title
Ken Monahan
Organization
VUMC
ken.monahan@vanderbilt.edu
6153222318

Study Officials

  • Ken Monahan, MD

    VUMC

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: small pilot study to test technical feasibility
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medicine

Study Record Dates

First Submitted

April 3, 2020

First Posted

April 7, 2020

Study Start

August 27, 2020

Primary Completion

August 25, 2021

Study Completion

March 1, 2024

Last Updated

April 9, 2024

Results First Posted

July 12, 2022

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)