The Evolution of Systemic Microvascular Reactivity in Heart Transplant Patients

Sponsor
National Institute of Cardiology, Laranjeiras, Brazil (Other)
Overall Status
Recruiting
CT.gov ID
NCT05729009
Collaborator
(none)
31
1
4
7.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: skin microvascular reactivity

Detailed Description

Introduction: Systemic microvascular reactivity (MR) is an essential component of cardiovascular physiology, being studied through non-invasive techniques in readily accessible body regions, such as the skin surface. Heart transplant (HT) is a treatment considered to selected patients, with advanced heart failure. The main cause of long-term mortality after HT is graft vascular disease (GVD), a condition which starts with endothelial dysfunction. To know the evolution of systemic MR in patients subjected to HT can help to find prognostic factors. Objective: The present study aims to perform the prospective evaluation of systemic MR in adult patients, before and two years after HT, at a quaternary hospital, correlating the findings with clinical variables. Methods: Systemic MR will be evaluated in the skin of the forearm using laser speckle contrast imaging with acetylcholine (ACh) iontophoresis, followed by postocclusive reactive hyperemia (PORH), before and after HT. Measurements will be correlated to patient clinical profile, hemodynamic and echocardiographic data. Expected results: The evolution of systemic MR may aid in the comprehension of cardiovascular physiology in HT patients, and possibly suggest the non-invasive evaluation of skin microcirculation as an ancillary tool in the clinical evaluation of these patients.

Study Design

Study Type:
Observational
Anticipated Enrollment :
31 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
The Evolution of Systemic Microvascular Reactivity in Heart Transplant Patients
Actual Study Start Date :
Oct 1, 2022
Anticipated Primary Completion Date :
Feb 1, 2023
Anticipated Study Completion Date :
Feb 1, 2023

Arms and Interventions

Arm Intervention/Treatment
heart transplantation

Diagnostic Test: skin microvascular reactivity
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.

Outcome Measures

Primary Outcome Measures

  1. Baseline and post-iontophoresis of acetylcholine endothelium-dependent skin microvascular reactivity [Microvascular reactivity will be evaluated 20-minute rest in the supine position in a temperature-controlled room.]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Inclusion Criteria:
  • capability to understand the objectives of the research and to fulfill the Term of Consent
Exclusion Criteria:
  • Pregnancy, acute infection diagnosis, use of circulatory assistance devices

Contacts and Locations

Locations

Site City State Country Postal Code
1 Eduardo TibiriƧƔ Rio de Janeiro Brazil 22240006

Sponsors and Collaborators

  • National Institute of Cardiology, Laranjeiras, Brazil

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Eduardo Tibirica, MD, PhD, Principal Investigator, National Institute of Cardiology, Laranjeiras, Brazil
ClinicalTrials.gov Identifier:
NCT05729009
Other Study ID Numbers:
  • 45581521.0.0000.5272
First Posted:
Feb 15, 2023
Last Update Posted:
Feb 16, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Feb 16, 2023