Can the Ergometric Test in Flu-like Syndrome Help in the... | NCT07007377

Studies
Can the Ergometric Test in Flu-like Syndrome Help in the Outcome Analysis of Unvaccinated Patients

NCT07007377

Sponsor

University of Sao Paulo

Status

Completed

Last Update Posted

May 19, 2026Actual

Enrollment

62Actual

Phase

Not provided

Conditions

Flu-like Syndrome
FLU
Flu-like Symptoms
Vaccination

Interventions

Follow-up

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2025Actual

Primary Completion Date

Aug 29, 2025Actual

Completion Date

Dec 5, 2025Actual

First Submitted Date

Mar 27, 2025

First Submission Date that Met QC Criteria

Jun 2, 2025

First Posted Date

Jun 5, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 15, 2026

Last Update Posted Date

May 19, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Pedro Gabriel Senger Braga, PhD, Post-doctoral student, Manager of research from Clinica Pró-Coração, University of Sao PauloPrincipal Investigator

Lead Sponsor

University of Sao PauloOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

62Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Vaccinated		Vaccinated subjects	Other: Follow-up
Non-vaccinated		Non-vaccinated subjects	Other: Follow-up

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Follow-up	Other	Follow-up	Non-vaccinated Vaccinated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Symptoms	The investigators will document whether the symptoms are present or not.	7 and 14 days after treadmill exercise test

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

flu-symptoms

Exclusion Criteria:

recent orthopedic surgery

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adults with flu symptoms, which were vaccinated or not.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clínica Pró-Coração		São Paulo	São Paulo	05021010	Brazil

IPD Sharing Statement Module

Plan to Share IPD

Description

Data protection

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided