Cardiac Morphology and Function in Individuals With Autonomic Dysreflexia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSwiss Paraplegic Research, Nottwil
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
congenital heart defects
valvular disease(s)
cardiomyopathy
medium to severe arrhythmia
Trial population
Participants will be recruited from all patients with a chronic spinal cord injury arriving for a routine urology check-up at the Swiss Paraplegic Center in Nottwil, Switzerland
Trial design
Design model
Case-control
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
48 Participants
are grouped into 2 trial groupsGroup A: AD+
Group B: AD-
Trial outcomes
Primary outcomes
1
Left ventricular end-diastolic volume (ml)
Left ventricular end-diastolic volume assessed by cardiac MRI
Time frame
baselineSecondary outcomes
1
Left ventricular mass (g)
Left ventricular mass assessed by cardiac MRI
Time frame
baseline2
Left ventricular end systolic volume (ml)
Left ventricular end systolic volume assessed by cardiac MRI
Time frame
baseline3
Left ventricular ejection fraction (%)
Percentage of blood pumped out of the heart's left ventricle with each contraction assessed by cardiac MRI
Time frame
baseline4
B-type natriuretic peptide level (pg/ml)
B-type natriuretic peptide levels in blood serum
Time frame
baselineOther outcomes
1
biological sex
biological sex assigned at birth
Time frame
at enrolment2
age (years)
age
Time frame
at enrolment3
body height (cm)
body height
Time frame
at enrolment4
body mass (kg)
body mass
Time frame
at enrolmentSponsors and contacts
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Source ClinicalTrials.gov