NCT07007377

Brief Summary

During the flu-like syndrome, the cardiovascular risk is increased, especially in the elderly. Understanding whether blood pressure assessment during an exercise test can aid in the understanding of patient outcomes, thereby improving prognostic ability in clinical practice, is the focus of the present study. Therefore, the aim of this study is to evaluate the hemodynamic response of adults with flu-like symptoms, both vaccinated and unvaccinated, and to conduct a 30-day follow-up for assessment. Patients who are indicated for an ergometric test and present with flu-like syndrome will be selected. We will inquire about their vaccination history and perform the ergometric test to evaluate test duration, arrhythmias, and ischemias

Trial Health

87
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2025

Shorter than P25 for all trials

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 27, 2025

Completed
5 days until next milestone

Study Start

First participant enrolled

April 1, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 5, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 29, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 5, 2025

Completed
Last Updated

May 19, 2026

Status Verified

June 1, 2025

Enrollment Period

5 months

First QC Date

March 27, 2025

Last Update Submit

May 15, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Can the ergometric test in flu-like syndrome help in the outcome analysis of unvaccinated patients?

    The investigators will analyze whether different responses to exertion, such as blood pressure disorders, are more evident in individuals with or without symptoms who have or have not been vaccinated.

    1 month

Secondary Outcomes (1)

  • Symptoms

    7 and 14 days after treadmill exercise test

Study Arms (2)

Vaccinated

Vaccinated subjects

Other: Follow-up

Non-vaccinated

Non-vaccinated subjects

Other: Follow-up

Interventions

Follow-up

Non-vaccinatedVaccinated

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults with flu symptoms, which were vaccinated or not.

You may qualify if:

  • flu-symptoms

You may not qualify if:

  • recent orthopedic surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clínica Pró-Coração

São Paulo, São Paulo, 05021010, Brazil

Location

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, Post-doctoral student, Manager of research from Clinica Pró-Coração

Study Record Dates

First Submitted

March 27, 2025

First Posted

June 5, 2025

Study Start

April 1, 2025

Primary Completion

August 29, 2025

Study Completion

December 5, 2025

Last Updated

May 19, 2026

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Data protection

Locations