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RecruitingNCT07456722HEART_REMOD_ADUpdated Aug 27, 2026

Cardiac Morphology and Function in Individuals With Autonomic Dysreflexia

An observational study in Autonomic Dysreflexia, Spinal Cord Injuries and Disorders (SCI/D) and Cardiac Remodeling, sponsored by Swiss Paraplegic Research, Nottwil. Recruiting at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-27.

Sponsored by Swiss Paraplegic Research, Nottwil · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
48
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Autonomic Dysreflexia
  • Spinal Cord Injuries and Disorders (SCI/D)
  • Cardiac Remodeling
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study 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

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

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
04

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
48 participants (estimated)
Patient registry
No

Groups and cohorts

  • AD+

    Spinal Cord Injury, above Th6, AIS A or B, Autonomic Dysreflexia

  • AD-

    Spinal Cord Injury, below Th10, AIS A or B, no Autonomic Dysreflexia

05

What researchers measure

Primary outcomes

  1. Left ventricular end-diastolic volume (ml)

    Left ventricular end-diastolic volume assessed by cardiac MRI

    Time frame: baseline

Secondary outcomes

  1. Left ventricular mass (g)

    Left ventricular mass assessed by cardiac MRI

    Time frame: baseline

  2. Left ventricular end systolic volume (ml)

    Left ventricular end systolic volume assessed by cardiac MRI

    Time frame: baseline

  3. Left ventricular ejection fraction (%)

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

    Time frame: baseline

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

    B-type natriuretic peptide levels in blood serum

    Time frame: baseline

Other outcomes

  1. biological sex

    biological sex assigned at birth

    Time frame: at enrolment

  2. age (years)

    age

    Time frame: at enrolment

  3. body height (cm)

    body height

    Time frame: at enrolment

  4. body mass (kg)

    body mass

    Time frame: at enrolment

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

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

    Time frame: at enrolment

  6. level of physical activity

    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

    Time frame: at enrolment

06

Study locations

1 of 1 sites recruiting
  • Swiss Paraplegic Center
    Nottwil, 6207, Switzerland
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07456722
Lead sponsor
Swiss Paraplegic Research, Nottwil
Responsible party
Sponsor
First posted
Mar 6, 2026
Start date
Jun 1, 2026
Primary completion
Jul 31, 2028 (estimated)
Completion
Oct 31, 2028 (estimated)
Last update
Aug 27, 2026

Study contacts

Jörg Krebs, PD Dr. med. vet. PhD
Contact
joerg.krebs@paraplegie.ch
+41 41 939 5946
Florian van Dellen, Dr. sc.
Contact
florian.vandellen@paraplegie.ch
+41 41 939 6542
Jens Wöllner, Prof. Dr. med.
principal investigator · Swiss Paraplegic Centre

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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