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NCT Number: NCT07151222

Role of Red Blood Cells in Cardiovascular Disease

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.

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

25 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Karolinska Institutet

Stockholm, Swsden, 17176, Sweden

Location status: Recruiting

Location contact

Stina Smetana, Nurse

CONTACT

[email protected]

+46 725841182

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Type 2 diabetes

Exclusion criteria

-

Treatment and study plan

Primary outcomes

  1. 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

    The function of red blood cells (RBCs) are investigated in isolated heart preparations and in isolated aorta.

    The heart preparations are subjected to ischemia followed by 60 min reperfusion and RBCs are administered into the coronary circulation at the onset of ischemia. Left ventricular developed pressure is recorded as readout of left ventricular function. Final infarct size is determined at the end of the reperfusion period.

    Isolated arteries are co-incubated with the RBCs for 18 h. Following the incubation, the arteries are mounted in myographs for the determination of endothelium-dependent and endothelium-independent relaxations.

Secondary outcomes

  1. Red blood cell production of reactive oxygen species

    Time frame: At baseline and following ex vivo inhibition of ROS formation.

    Red blood cell (RBC) production of reactive oxygen species (ROS) is determined at baseline and following incubation of the RBCs with pharmacological tools that modulate different sources of ROS formation. These include nitric oxide synthase inhibitors, NADPH-oxidase inhibitors, arginase inhibitors.

Study contacts

Contact information is provided by the study sponsor or research team.

John Pernow, MD

CONTACT

[email protected]

+46704848361

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Karolinska University Hospital

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2030
Study completion
2031
First posted
Sep 3, 2025
Registry last updated
Sep 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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