Cardiac Morphology and Function in Individuals With Autonomic Dysreflexia

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07456722

Acronym

HEART_REMOD_AD

Enrollment

Registered

2026-03-06

Start date

2026-06-01

Completion date

2028-10-31

Last updated

2026-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autonomic Dysreflexia, Cardiac Remodeling, Spinal Cord Injuries and Disorders (SCI/D)

Brief summary

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Left ventricular end-diastolic volume (ml)	baseline	Left ventricular end-diastolic volume assessed by cardiac MRI

Secondary

Measure	Time frame	Description
Left ventricular mass (g)	baseline	Left ventricular mass assessed by cardiac MRI
Left ventricular end systolic volume (ml)	baseline	Left ventricular end systolic volume assessed by cardiac MRI
Left ventricular ejection fraction (%)	baseline	Percentage of blood pumped out of the heart's left ventricle with each contraction assessed by cardiac MRI
B-type natriuretic peptide level (pg/ml)	baseline	B-type natriuretic peptide levels in blood serum

Countries

Switzerland

Contacts

CONTACTJörg Krebs, PD Dr. med. vet. PhD

joerg.krebs@paraplegie.ch+41 41 939 5946

CONTACTFlorian van Dellen, Dr. sc.

florian.vandellen@paraplegie.ch+41 41 939 6542

PRINCIPAL_INVESTIGATORJens Wöllner, Prof. Dr. med.

Swiss Paraplegic Centre

Outcome results