Autonomic DysreflexiaHEART_REMOD_ADNCT07456722
Cardiac Morphology and Function in Individuals With Autonomic Dysreflexia
An observational study of Autonomic Dysreflexia and Spinal Cord Injuries and Disorders (SCI/D), run by Swiss Paraplegic Research, Nottwil at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autonomic Dysreflexia, Spinal Cord Injuries and Disorders (SCI/D), Cardiac Remodeling
- How many people
- 48 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jun 2026to 31 Oct 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- congenital heart defects
- valvular disease(s)
- cardiomyopathy
- medium to severe arrhythmia
- myocardial infarction
- comorbidities causing morphologic heart changes including primary hypertension, aortic stenosis
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Swiss Paraplegic Center
Nottwil, 6207
Jens Wöllner, PD Dr. med., +41939 59 41, jens.wöllner@paraplegie.ch
About this study
Official title: 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.
- Medical subject headings
- Autonomic Dysreflexia, Spinal Cord Injuries, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Left ventricular end-diastolic volume (ml)
Left ventricular end-diastolic volume assessed by cardiac MRI
Measured: baseline
Secondary outcomes (4)
Left ventricular mass (g)
Left ventricular mass assessed by cardiac MRI
Measured: baseline
Left ventricular end systolic volume (ml)
Left ventricular end systolic volume assessed by cardiac MRI
Measured: baseline
Left ventricular ejection fraction (%)
Percentage of blood pumped out of the heart's left ventricle with each contraction assessed by cardiac MRI
Measured: baseline
B-type natriuretic peptide level (pg/ml)
B-type natriuretic peptide levels in blood serum
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start1 Jun 2026
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autonomic DysreflexiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Swiss Paraplegic Research, Nottwil
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Jens Wöllner, Prof. Dr. med., Principal investigator, Swiss Paraplegic Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07456722
- Sponsor's protocol ID
- 2024-20
- Acronym
- HEART_REMOD_AD
- Status last verified
- Aug 2026
- First submitted
- 2 Mar 2026
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Cardiac Morphology and Function in Individuals With and Without Autonomic Dysreflexia Due to Spinal Cord Injury or Disease
- ClinicalTrials.gov ID
- NCT07456722
- Acronym / sponsor ID
- HEART_REMOD_AD / 2024-20
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Swiss Paraplegic Research, NottwilResearch network
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Oct 2028 (estimated)
- First posted
- 6 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (14 listed)
- congenital heart defects
- valvular disease(s)
- cardiomyopathy
- medium to severe arrhythmia
- myocardial infarction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Left ventricular end-diastolic volume (ml)
Time frame: baseline
Left ventricular end-diastolic volume assessed by cardiac MRI
4 secondary outcomes
Left ventricular mass (g)
Time frame: baseline
Left ventricular end systolic volume (ml)
Time frame: baseline
Left ventricular ejection fraction (%)
Time frame: baseline
B-type natriuretic peptide level (pg/ml)
Time frame: baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Individual participant dataSharing planned: No
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Deciphering Preserved Autonomic Function After Multiple Sclerosis
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Non-invasive Spinal Cord Stimulation and Blood Pressure Regulation After Spinal Cord Injury
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NO AD: Use of Nitric Oxide (NO) Donors for the Prevention of Autonomic Dysreflexia (AD) During Bowel Care Following SCI
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jens Wöllner, Prof. Dr. med. principal investigator
Swiss Paraplegic Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autonomic Dysreflexia and Spinal Cord Injuries and Disorders (SCI/D), run by Swiss Paraplegic Research, Nottwil at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jörg Krebs, PD Dr. med. vet. PhD (+41 41 939 5946, joerg.krebs@paraplegie.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left ventricular end-diastolic volume (ml) (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.