Cardiac Morphology and Function in Individuals With Autonomic Dysreflexia (HEART_REMOD_AD)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Autonomic Dysreflexia; Spinal Cord Injuries and Disorders (SCI/D); Cardiac Remodeling

• Study Type: Observational
• Enrollment (Estimated): 48

Contacts and Locations

• Study Contact: Name: Jörg Krebs, PD Dr. med. vet. PhD; Phone Number: +41 41 939 5946; Email: joerg.krebs@paraplegie.ch
• Study Contact Backup: Name: Florian van Dellen, Dr. sc.; Phone Number: +41 41 939 6542; Email: florian.vandellen@paraplegie.ch

Study Locations

• Switzerland
  • Nottwil, Switzerland, 6207
    • Swiss Paraplegic Center
    • Contact: Jens Wöllner, PD Dr. med.; Phone Number: +41939 59 41; Email: jens.wöllner@paraplegie.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
biological sex	biological sex assigned at birth	at enrolment
age (years)	age	at enrolment
body height (cm)	body height	at enrolment
body mass (kg)	body mass	at enrolment
duration of spinal cord injury or disease (years)	time from occurrence of spinal cord injury or disease to study enrolment	at enrolment
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	at enrolment

Collaborators and Investigators

• Sponsor: Swiss Paraplegic Research, Nottwil
• Investigators: Principal Investigator: Jens Wöllner, Prof. Dr. med., Swiss Paraplegic Centre

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): October 31, 2028

Study Registration Dates

• First Submitted: March 2, 2026
• First Submitted That Met QC Criteria: March 2, 2026
• First Posted (Actual): March 6, 2026

Study Record Updates

• Last Update Posted (Actual): March 11, 2026
• Last Update Submitted That Met QC Criteria: March 9, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Pathologic Processes; Trauma, Nervous System; Spinal Cord Diseases; Autonomic Nervous System Diseases; Pathological Conditions, Signs and Symptoms; Disease; Spinal Cord Injuries; Autonomic Dysreflexia
• Other Study ID Numbers: 2024-20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No