NCT07238465 Exploring Sympathetic Nervous System Function in Individuals With Down Syndrome
| NCT ID | NCT07238465 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | University of Colorado, Denver |
| Condition | Down Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2026-04-06 |
| Primary Completion | 2029-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 200 participants in total. It began in 2026-04-06 with a primary completion date of 2029-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Down syndrome (DS), the most common genetic cause of intellectual disability, is associated with widespread organ dysfunction, including abnormalities in the autonomic nervous system (ANS). The ANS regulates critical functions such as heart rate (HR) and blood pressure (BP), both essential for maintaining homeostasis and supporting physical activity. Individuals with DS often exhibit blunted HR responses to exercise-typically \~30 beats per minute below expected levels-suggesting reduced sympathetic nervous system (SNS) activity. The SNS governs rapid changes in HR and BP during stress by releasing catecholamines: epinephrine (from the adrenal medulla) and norepinephrine (from sympathetic nerve endings). Despite its importance, SNS function has not been comprehensively assessed among individuals with DS. This study addresses a critical knowledge gap by evaluating SNS responses to physiological stressors in individuals with DS. The investigators will measure beat-to-beat HR and BP, along with plasma catecholamine levels, in response to sympathetic activation, comparing individuals with DS to age- and sex-matched controls. Understanding the mechanisms of SNS dysfunction in DS is vital, as it likely underlies reduced exercise capacity and contributes to broader clinical challenges. These insights may guide targeted interventions to improve cardiovascular function, physical capacity, and overall quality of life in this understudied population.
Eligibility Criteria
Inclusion Criteria: * 18-50 yrs old and apparently healthy individuals * Ability to understand the study and give assent to participate * Has a study partner who can attend all visits for the individuals with DS, and answer questionnaires, provide consent when necessary * Corrected or non-existent congenital heart disease * Euthyroid or on stable thyroid medication dose for at least 6 months * Free from cardiovascular, pulmonary, inflammatory, or metabolic disease in the past 6 months that would prevent participation in study procedures * BMI \<45kg/m2 * Ability to tolerate repeated blood draws / catheter placement Exclusion Criteria: * Hypertension (resting systolic blood pressure \[SBP\] ≥140 and/or diastolic blood pressure \[DBP\] ≥90 mmHg) this includes those on medications to treat hypertension * Hypotension (resting BP of \<90/60 mmHg) * Cancer in the last six months * Any heart-rate-altering medications or any other medication that may modify metabolic responses * Self-reported diabetes or use of glucose-lowering medication * Tobacco products, including vaping, or marijuana use * Currently pregnant * Post-menopausal women Specific Exclusion Criteria for Certain Stressors: * Orthopedic limitations that would prohibit exercise or movement for exercise * Fracture of limb to be immersed for CPT * Open cut or sore on hand to be immersed for CPT * Raynaud's syndrome for CPT
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07238465 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 50 Years, studying Down Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07238465 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 200 participants.
Is NCT07238465 currently recruiting?
Yes, NCT07238465 is actively recruiting participants. Contact the research team at sara.r.sherman@cuanschutz.edu for enrollment information.
Where is the NCT07238465 trial being conducted?
This trial is being conducted at Aurora, United States.
Who is sponsoring the NCT07238465 clinical trial?
NCT07238465 is sponsored by University of Colorado, Denver. The trial plans to enroll 200 participants.