Brain Heart InterActioNs in Cardiac Arrest. Ancillary Study of the HEAVENwARd Trial

Recruiting now

Conditions studied: Cardiac Arrest

In brief

Despite advances in post-resuscitation care of patients with cardiac arrest (CA), the majority of survivors who are treated after restoration of spontaneous circulation (ROSC) will have sequelae of hypoxic-ischemic brain injury ranging from mild cognitive impairment to a vegetative state. Current recommendations suggest using a multimodal approach to predict poor prognosis, meaning combining markers together. Yet, a substantial proportion of patients do not have a clear prognostic evaluation even when applying the latest ESICM recommendations algorithm published in 2021. It is therefore important to identify new prognostic markers to predict both unfavorable and favorable outcomes. Data regarding the pathophysiological mechanisms of post-anoxic encephalopathy suggest a diffuse anoxo-ischemic injury. However, post-mortem neuropathology data suggest that these lesions do not uniformly affect neuroanatomical structures, with some regions (especially hippocampal and insular) appearing more sensitive to anoxia. Conversely, the brainstem appears less affected by anoxic lesions. Under physiological conditions, there are interactions between the heart and the brain, and between the brain and the heart mainly related to the autonomic nervous system, through interactions between central cortical control structures (especially insular) and brainstem structures (at the level of the bulb) and peripheral structures of the heart. Exploring the pathophysiological mechanisms of heart-brain interactions post-CA could thus help better understand the pathophysiology of anoxo-ischemic encephalopathy, before considering potential therapeutic targets. Furthermore, this heart-brain dysfunction could have prognostic value. Indeed, recent studies in healthy subjects and patients with consciousness disorders suggest that autonomic nervous system activity measured by brain-heart interactions could be a reliable marker of consciousness and cognitive processing. These coupled heart-brain interactions can be evaluated through synchronous electroencephalogram (EEG) and electrocardiogram (ECG) recordings, as there are coupled interactions between the signals of these two organs. The existence of abnormal brain-heart coupling could be associated, on the one hand, with the severity of post-anoxic encephalopathy, and on the other hand, with neurological prognosis in patients with persistent coma post-CA. This ancillary study of a multicentre prospective cohort "HEAVENwARd study" (NCT06044922) will assess the prevalence and prognostic value of bilateral brain-heart interactions in comatose patients after CA.

Key facts

Study ID: NCT06327334
Run by: CMC Ambroise Paré
People needed: 200
Starts: 2024-11-25
Expected to finish: 2027-12-15
Last updated by the study team: 2025-03-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Admitted in intensive care unit (ICU) after resuscitation from cardiac arrest (in-hospital or out-of-hospital)
Coma (Glasgow score < 8) after ROSC, requiring sedation and targeted temperature management for at least 24h
EEG with ECG lead performed in routine care

You may not qualify if…

Dying patient (Limitation of life support techniques at admission to the ICU)
Limitation of life sustaining treatment before EEG
Non-Sinus Rhythm
Pregnant or breastfeeding women
Patient under protection of the adults (guardianship, curators or safeguard of justice)
Opposition by the trusted person or by the patient

Where it is running

Brest University Hospital — Brest, Brittany Region, France (enrolling)
Nantes University Hospital — Nantes, Pays de la Loire Region, France (enrolling)
Marseille University Hospital — Marseille, Provence-Alpes-Côte d'Azur Region, France (enrolling)
Ambroise Paré - Hartmann Private Hospital Group — Neuilly-sur-Seine, Île-de-France Region, France (enrolling)
Cochin Hospital — Paris, Île-de-France Region, France (enrolling)

Full record on ClinicalTrials.gov

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