NCT07456722

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for all trials

Timeline
30mo left

Started May 2026

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress1%
May 2026Oct 2028

First Submitted

Initial submission to the registry

March 2, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 6, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2028

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2028

Last Updated

March 11, 2026

Status Verified

March 1, 2026

Enrollment Period

2.3 years

First QC Date

March 2, 2026

Last Update Submit

March 9, 2026

Conditions

Autonomic DysreflexiaSpinal Cord Injuries and Disorders (SCI/D)Cardiac Remodeling

Outcome Measures

Primary Outcomes (1)

  • Left ventricular end-diastolic volume (ml)

    Left ventricular end-diastolic volume assessed by cardiac MRI

    baseline

Secondary Outcomes (4)

  • Left ventricular mass (g)

    baseline

  • Left ventricular end systolic volume (ml)

    baseline

  • Left ventricular ejection fraction (%)

    baseline

  • B-type natriuretic peptide level (pg/ml)

    baseline

Other Outcomes (6)

  • biological sex

    at enrolment

  • age (years)

    at enrolment

  • body height (cm)

    at enrolment

  • +3 more other outcomes

Study Arms (2)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Swiss Paraplegic Center

Nottwil, 6207, Switzerland

Location

MeSH Terms

Conditions

Autonomic DysreflexiaSpinal Cord InjuriesDisease

Condition Hierarchy (Ancestors)

Autonomic Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemSpinal Cord DiseasesCentral Nervous System DiseasesWounds and InjuriesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jens Wöllner, Prof. Dr. med.

    Swiss Paraplegic Centre

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jörg Krebs, PD Dr. med. vet. PhD

CONTACT

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

Florian van Dellen, Dr. sc.

CONTACT

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

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2026

First Posted

March 6, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

July 31, 2028

Study Completion (Estimated)

October 31, 2028

Last Updated

March 11, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)