NCT05729009

Brief Summary

The evolution of systemic microvascular reactivity may aid in the comprehension of cardiovascular physiology in heart transplantation patients, and possibly suggest the non-invasive evaluation of skin microcirculation as an ancillary tool in the clinical evaluation of these patients.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at below P25 for all trials

Timeline
7mo left

Started Oct 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress86%
Oct 2022Dec 2026

Study Start

First participant enrolled

October 1, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 6, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 15, 2023

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

4.2 years

First QC Date

February 6, 2023

Last Update Submit

April 7, 2026

Conditions

Heart Transplantation

Outcome Measures

Primary Outcomes (1)

  • Baseline and post-iontophoresis of acetylcholine endothelium-dependent skin microvascular reactivity

    Evaluation of systemic microvascular reactivity induced by endothelium-dependent agents. Microvascular reactivity will be evaluated using a non-invasive and operator -independent methodology, named laser speckle contrast imaging, coupled with skin iontophoresis of vasodilator agents. Cutaneous microvascular flow will be measured in arbitrary perfusion units, divided by mean arterial pressure, to yield cutaneous vascular conductance.

    Microvascular reactivity will be evaluated 20-minute rest in the supine position in a temperature-controlled room.

Study Arms (1)

heart transplantation

Diagnostic Test: skin microvascular reactivity

Interventions

skin microvascular reactivityDIAGNOSTIC_TEST

Laser-based method for evaluating non-invasive, operator-independent systemic microvascular function that detects microvascular flow in the skin for the evaluation of systemic vascular endothelial function.

heart transplantation

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

adult individuals from the cohort of heart failure patients under evaluation for heart transplantation, at the National Institute of Cardiology, Rio de Janeiro, Brazil

You may qualify if:

  • capability to understand the objectives of the research and to fulfill the Term of Consent

You may not qualify if:

  • Pregnancy, acute infection diagnosis, use of circulatory assistance devices

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eduardo Tibiriçá

Rio de Janeiro, 22240006, Brazil

RECRUITING

Central Study Contacts

Eduardo Tibirica Tibirica, MD, PhD

CONTACT

+55-21-99914-6075etibi@uol.com.br

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 6, 2023

First Posted

February 15, 2023

Study Start

October 1, 2022

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

April 13, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)