Better Understanding of Fatigue After STroke

NCT06292377 | Recruiting

• 1 other identifier: BRUFAST
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 2

Brief Summary

Stroke is worldwide the second most common cause of death following heart attack and the leading cause of disability. Post-stroke fatigue (PSF) is a common complication after stroke and can be defined as 'an overwhelming exhaustion or tiredness, not related to exertion, which does not typically improve with rest'. Fatigue following stroke can be divided into early (\< 3 months) and late (\> 3 months) fatigue. PSF can have a considerable impact on a person's everyday activities and quality of life, participation in the rehabilitation process and levels of caregiver burden. Yet no efficient treatment exists to prevent or cure PSF because the pathophysiology remains unclear and seems to be multifaceted. Autonomic dysfunction is a common complication after stroke, associated with higher morbidity and mortality. An easy tool to measure the function of the autonomic nervous system (ANS) is heart rate variability (HRV), which is defined as the beat-to-beat variation of the heart rate (= interbeat interval (IBI)). It is the result of alterations in the sympathetic and parasympathetic nervous system. In recent systematic reviews, authors stipulate that HRV can be regarded as a prognostic factor for short- and long-term stroke outcomes. HRV can be derived from 24 hours, 5 minutes (short-term) and \< 5 minutes (ultra-short-term) measurements by applying time-domain and frequency-domain indices. Autonomic dysfunction has been related to chronic fatigue syndrome, in addition to fatigue in multiple sclerosis, Parkinson's disease and myasthenia gravis. However, to the best of our knowledge, the relationship between autonomic dysfunction and PSF has not yet been fully investigated. Fatigue is also common in cardiovascular diseases, especially in patients with heart failure (HF). HF can contribute to fatigue after stroke, independently of stroke. Cardiac complications after acute ischemic stroke (AIS), such as arrhythmias, cardiac dysfunction and myocardial injury, are frequent. The so-called 'stroke-heart syndrome', a concept introduced in 2018, describes a broad spectrum of cardiac changes observed in 10-20% of patients with AIS within the first month after stroke onset, with a peak in the first 72 hours. A dysregulation in the neural-cardiac control after stroke is suspected to be the cause of the cascade leading to cardiac complications, in which autonomic dysfunction and inflammation seem to be part of the underlying mechanism. Based on previous studies and by analogy with other neurological diseases, the investigators hypothesize that autonomic dysfunction following AIS contributes to PSF and that patients presenting heart failure as a complication following AIS have an increased risk of PSF. To confirm this hypothesis, the investigators will conduct a prospective, interventional study where patients who are hospitalized at the Stroke Unit, within 72 hours after stroke symptom onset, will be included. Evaluation will take place of (a) the relationship between autonomic dysfunction (HRV) and early and late PSF, and of (b) the relationship between cardiac dysfunction and early PSF and late PSF. There will also be an investigation into following elements:

• the association between early and late PSF and (a) certain inflammatory markers at admission (CRP, NLR), (b) stroke localization and (c) baseline imaging markers of brain frailty.
• the role of pre-existing fatigue + pre-existing or post-stroke newly diagnosed cognitive impairment, depression and sleep disturbances on the course of PSF.

Conditions

Stroke

Outcome Measures

Primary Outcomes (18)

• Heart rate variability (HRV)

  Heart rate variability is assessed by ECG monitoring and analyzed by means of Kubios software.

  Baseline (hospital admission)

• Heart rate variability (HRV)

  Heart rate variability is assessed by ECG monitoring and analyzed by means of Kubios software.

  3 months after baseline

• Heart rate variability (HRV)

  Heart rate variability is assessed by ECG monitoring and analyzed by means of Kubios software.

  12 months after baseline

• Transthoracic echography (TTE)

  Cardiac function will be evaluated by a cardiologist with transthoracic echography (TTE).

  Baseline (hospital admission)

• Transthoracic echography (TTE)

  Cardiac function will be evaluated by a cardiologist with transthoracic echography (TTE).

  3 months after baseline

• Transthoracic echography (TTE)

  Cardiac function will be evaluated by a cardiologist with transthoracic echography (TTE).

  12 months after baseline

• Fatigue Severity Scale (FSS-7)

  The 7 items Fatigue Severity Scale (FSS-7) is a method of evaluating the impact of fatigue. The FSS-7 is a questionnaire with 7 statements rated from 1 (disagree) to 7 (agree). No official cut-off has been established, but most studies adopt the approach of using the average score: an average of ≥4 suggests clinically relevant fatigue, while an average \<4 indicates low to moderate fatigue.

  3 months after baseline

• Fatigue Severity Scale (FSS-7)

  The 7 items Fatigue Severity Scale (FSS-7) is a method of evaluating the impact of fatigue. The FSS-7 is a questionnaire with 7 statements rated from 1 (disagree) to 7 (agree). No official cut-off has been established, but most studies adopt the approach of using the average score: an average of ≥4 suggests clinically relevant fatigue, while an average \<4 indicates low to moderate fatigue.

  12 months after baseline

• N-terminal pro-brain natriuretic peptide (NT-proBNP)

  NT-proBNP blood levels

  Baseline (hospital admission)

• N-terminal pro-brain natriuretic peptide (NT-proBNP)

  NT-proBNP blood levels

  3 months after baseline

• N-terminal pro-brain natriuretic peptide (NT-proBNP)

  NT-proBNP blood levels

  12 months after baseline

• cardiac troponin (cTnT)

  cardiac troponin blood levels

  Baseline (hospital admission)

• Non-Invasive Blood Pressure (NIBP)

  Non-invasive blood pressure (NIBP) is measured continuously using a Finapres device. Outcomes are recorded as real-time systolic, diastolic, and mean arterial pressure values.

  Baseline (hospital admission)

• Non-Invasive Blood Pressure (NIBP)

  Non-invasive blood pressure (NIBP) is measured continuously using a Finapres device. Outcomes are recorded as real-time systolic, diastolic, and mean arterial pressure values.

  3 months after baseline

• Non-Invasive Blood Pressure (NIBP)

  Non-invasive blood pressure (NIBP) is measured continuously using a Finapres device. Outcomes are recorded as real-time systolic, diastolic, and mean arterial pressure values.

  12 months after baseline

• Baroreflex Sensitivity (BRS)

  Baroreflex Sensitivity (BRS) quantifies the autonomic regulation of blood pressure by measuring the change in heart rate in response to spontaneous fluctuations in blood pressure. It is calculated from continuous blood pressure and ECG recordings (using Finapres). BRS is expressed in ms/mmHg, with higher values indicating stronger baroreflex function.

  Baseline (hospital admission)

• Baroreflex Sensitivity (BRS)

  Baroreflex Sensitivity (BRS) quantifies the autonomic regulation of blood pressure by measuring the change in heart rate in response to spontaneous fluctuations in blood pressure. It is calculated from continuous blood pressure and ECG recordings (using Finapres). BRS is expressed in ms/mmHg, with higher values indicating stronger baroreflex function.

  3 months after baseline

• Baroreflex Sensitivity (BRS)

  Baroreflex Sensitivity (BRS) quantifies the autonomic regulation of blood pressure by measuring the change in heart rate in response to spontaneous fluctuations in blood pressure. It is calculated from continuous blood pressure and ECG recordings (using Finapres). BRS is expressed in ms/mmHg, with higher values indicating stronger baroreflex function.

  12 months after baseline

Secondary Outcomes (30)

• Blood CRP level

  Baseline (hospital admission)

• Blood neutrophil-to-lymphocyte ratio (NLR)

  Baseline (hospital admission)

• Stroke localization in the brain

  Baseline (hospital admission)

• Fazekas scale

  Baseline (hospital admission)

• Global cortical atrophy scale

  Baseline (hospital admission)

Study Arms (1)

Stroke patients

EXPERIMENTAL

Patients, hospitalized at the Stroke Unit of CHU Brugmann and UZ Brussel, after the clinical diagnosis of a first-ever ischemic stroke.

Diagnostic Test: ECG; Diagnostic Test: Transthoracic echography (TTE); Diagnostic Test: Blood sampling

Interventions

ECG DIAGNOSTIC_TEST

An electrocardiogram (ECG) is a simple, non-invasive test that records the electrical activity of the heart.

Stroke patients

Transthoracic echography (TTE) DIAGNOSTIC_TEST

A transthoracic echocardiogram (TTE) is a test that uses ultrasound (sound waves) to create images of the heart.

Stroke patients

Blood sampling DIAGNOSTIC_TEST

Blood sampling will include: complete blood count, serum creatinine and electrolytes, liver enzymes, fast lipid profile, glucose, HbA1C, thyroid-stimulating hormone (TSH), CRP, iron status, cardiac troponin (cTnT), N-terminal pro-brain natriuretic peptide (NT-proBNP).

Stroke patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18
• First-ever (suspicion of) ischemic stroke based on clinical examination and/or brain imaging
• Admitted at the stroke unit of CHU Brugmann and UZ Brussel
• Ability to participate in assessment of fatigue, cognitive, mood and sleep disturbances
• Ability to undergo MRI of the brain

You may not qualify if:

• Unable to speak French or Dutch
• Pre-existing stroke or other structural brain lesion
• Life expectancy \< 1 year
• Severe language impairment or dementia impeding assessment of fatigue, cognitive, mood and sleep disturbances
• Pregnancy or wish to become pregnant

Sponsors & Collaborators

• Brugmann University Hospital: lead

Study Sites (2)

CHU Brugmann

Brussels, 1020, Belgium

RECRUITING

UZ Brussel

Brussels, 1090, Belgium

RECRUITING

MeSH Terms

Conditions

Stroke

Interventions

Electrocardiography; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis; Specimen Handling; Clinical Laboratory Techniques; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Anissa Ourtani, MD

  CHU Brugmann

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anissa Ourtani, MD

CONTACT

3224754819; Anissa.OURTANI@chu-brugmann.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2024
• First Posted: March 5, 2024
• Study Start: June 7, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (2)