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NCT Number: NCT07456722

Cardiac Morphology and Function in Individuals With Autonomic Dysreflexia

This case-control study aims to investigate left ventricular remodeling in individuals with chronic spinal cord injury or disease (SCI/D) (≥10 years) and autonomic dysreflexia (AD) who have no prior cardiovascular history. The primary objective is to compare cardiac changes between 24 individuals with high-level SCI/D (above Th6) who have AD and 24 individuals with low-level SCI/D (below Th10) who do not have AD. A secondary objective examines how factors such as age, sex, injury duration, and physical activity are associated with cardiac remodeling.

All 48 participants will undergo cardiac MRI as well as blood measurement of B-type natriuretic peptid to assess cardiac morphology and function. The findings could shed light on a potentially underestimated cardiovascular risk factor in the SCI/D population.

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Key information

Conditions

Autonomic Dysreflexia Autonomic Nervous System Diseases Cardiac Remodeling Central Nervous System Diseases Disease Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Spinal Cord Diseases Spinal Cord Injuries Spinal Cord Injuries and Disorders (SCI/D) Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • adults aged 18 years or older
  • long-term (>10 years), motor-complete SCI/D (AIS A and B)
  • Group A (24 individuals): high-level (>Th6) SCI/D and autonomic dysreflexia
  • Group B (24 individuals): low-level (<Th10) SCI/D without autonomic dysreflexia
  • signed informed consent

Exclusion criteria

  • congenital heart defects
  • valvular disease(s)
  • cardiomyopathy
  • medium to severe arrhythmia
  • myocardial infarction
  • comorbidities causing morphologic heart changes including primary hypertension, aortic stenosis
  • comorbidities causing arterial hypertension
  • use of anti-hypertensive treatment
  • smokers
  • individuals after sacral deafferentation surgery
  • pregnancy
  • active implanted medical devices
  • claustrophobia
  • inability to comply with the measurement procedures

Treatment and study plan

Primary outcomes

  1. Left ventricular end-diastolic volume (ml)

    Time frame: baseline

    Left ventricular end-diastolic volume assessed by cardiac MRI

Secondary outcomes

  1. Left ventricular mass (g)

    Time frame: baseline

    Left ventricular mass assessed by cardiac MRI

  2. Left ventricular end systolic volume (ml)

    Time frame: baseline

    Left ventricular end systolic volume assessed by cardiac MRI

  3. Left ventricular ejection fraction (%)

    Time frame: baseline

    Percentage of blood pumped out of the heart's left ventricle with each contraction assessed by cardiac MRI

  4. B-type natriuretic peptide level (pg/ml)

    Time frame: baseline

    B-type natriuretic peptide levels in blood serum

Other outcomes

  1. biological sex

    Time frame: at enrolment

    biological sex assigned at birth

  2. age (years)

    Time frame: at enrolment

    age

  3. body height (cm)

    Time frame: at enrolment

    body height

  4. body mass (kg)

    Time frame: at enrolment

    body mass

  5. duration of spinal cord injury or disease (years)

    Time frame: at enrolment

    time from occurrence of spinal cord injury or disease to study enrolment

  6. level of physical activity

    Time frame: at enrolment

    self-reported hours of physical activity per week used to stratify participants into three groups: 1) not performing regular physical activity 2) exercising one to three hours per week and 3) more than three hours per week

Study contacts

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

Florian van Dellen, Dr. sc.

CONTACT

[email protected]

+41 41 939 6542

Jörg Krebs, PD Dr. med. vet. PhD

CONTACT

[email protected]

+41 41 939 5946

Sponsors and collaborators

Lead sponsor

Swiss Paraplegic Research, Nottwil

Network

Registry information

Official study title

Assessment of Cardiac Morphology and Function in Individuals With and Without Autonomic Dysreflexia Due to Spinal Cord Injury or Disease

Acronym: HEART_REMOD_AD

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Mar 6, 2026
Registry last updated
Mar 11, 2026

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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