Menu
Recruiting NCT07151222

Role of Red Blood Cells in Cardiovascular Disease

Observational Diabetes Mellitus

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Diabetes Mellitus. Basic parameters: 25 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Sweden
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

The Red Blood Cell as a Mediator and Therapeutic Target in Cardiovascular Disease

Overview

The risk of myocardial infarction is dependent on cardiovascular risk factors including type 2 diabetes (T2D) but underlying mechanisms are poorly understood. We identified that red blood cells (RBCs) mediate beneficial cardiovascular regulatory effects under hypoxic/ischemic conditions via signaling by nitric oxide (NO) and soluble guanylate cyclase (sGC) in the RBCs. The RBCs become dysregulated in T2D which induces endothelial and cardiac injury. This project investigates the signaling of RBCs in cardiovascular disease and explores novel therapeutic strategies that target RBC function in myocardial infarction and T2D. Aims To determine the * mechanisms behind cardioprotective effect of RBCs in myocardial infarction * signaling behind cardiovascular injury induced by RBCs in T2D Work plan RBCs collected from patients with myocardial infarction, patients with T2D and healthy controls are investigated in bioassays including isolated hearts of ischemia/reperfusion, endothelial function and cell cultures. Molecular mechanisms behind the effects of RBCs are identified with focus on the NO-sGC pathway in the RBCs. This project unravels the RBC as a mediator of cardiovascular disease and has the potential to identify novel therapeutic strategies by targeting RBC signaling.

Detailed description

The function of RBCs are investigated in functional bioassays and cell culture systems. The bioassays include isolated hearts subjected to ischemia-reperfusion and isolated arteries. the readouts are left ventricular function, infarct size and endothelial function . Comparisons are made between RBCs collected from patients with cardiovascular disease, type 2 diabetes and healthy controls. Pharmacological interventions are performed by ex vivo incubations with focus on the NO-sGC pathway.

Primary outcome measures

  • Red blood cell function defined as their ability to modulated post-ischemic recovery of left ventricular developed pressure, myocardial infarct size and endothelium-dependent relaxation. [Time frame: At 60 min of reperfusion]
Secondary outcome measures (1)
  • Red blood cell production of reactive oxygen species [Time frame: At baseline and following ex vivo inhibition of ROS formation.]

Eligibility criteria

Inclusion criteria

  • Type 2 diabetes

Exclusion criteria

\-

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Sweden · 1 center
  • Karolinska Institutet — Stockholm

Publications

  • Pernow J, Yang J. Red blood cells: a new target to prevent cardiovascular disease? Eur Heart J. 2024 Oct 21;45(40):4249-4251. doi: 10.1093/eurheartj/ehae454. No abstract available. PMID 39258963

Identifiers

NCT: NCT07151222 · 2024-02534

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗