Spermidine treatment for elderly patients with coronary artery disease
Polyamine Treatment in Elderly Patients With Coronary Artery Disease - a Randomized Controlled Trial
This study is testing if taking spermidine, a natural substance found in some foods, can help older adults with coronary artery disease feel better and improve their heart health over a year.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 65 Years to 90 Years |
| Sex | All |
| Sponsor | University of Aarhus Academic / other |
| Locations | 1 site (Aarhus, Jutland) |
| Trial ID | NCT06186102 on ClinicalTrials.gov |
What this trial studies
This clinical trial is investigating the effects of spermidine, a polyamine found in plant-derived foods, on elderly patients suffering from coronary artery disease. It is a randomized, double-blind, placebo-controlled study designed to assess whether a twelve-month regimen of spermidine can improve cardiovascular health and overall quality of life in this population. The study will include patients aged 65 and older with chronic ischemic heart disease and specific risk factors, comparing outcomes between those receiving spermidine and those receiving a placebo. The research aims to explore the potential benefits of dietary supplementation with spermidine in promoting healthy aging and reducing cardiovascular risks.
Who should consider this trial
Good fit: Ideal candidates are elderly individuals aged 65 and older with chronic ischemic heart disease and at least two additional cardiovascular risk factors.
Not a fit: Patients with unstable coronary syndrome, severe comorbidities, or significant cardiac conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could enhance cardiovascular health and longevity in elderly patients with coronary artery disease.
How similar studies have performed: While clinical data on spermidine supplementation is limited, preliminary findings suggest potential benefits in related populations, indicating a promising but novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 65 years * Chronic ischemic heart disease (previous revascularization or myocardial infarction) * Left ventricular ejection fraction of \> 40% And at least two of the following risk factors: * Type 2 diabetes, * Obesity (BMI ≥ 30 kg/m2), * Hypertension, * Previous LVEF \< 40%, * Left atrial volume index ≥ 30 mL/m2 * Left ventricular wall thickness ≥ 1.1 cm. Exclusion Criteria: * Unstable coronary syndrome * Significant and severe cardiac valve disease * Severe peripheral artery disease * Permanent atrial fibrillation * Pacemaker treatment * Chronic kidney disease with eGFR \<45 ml/min/1,73m2 * Severe comorbidity as judged by the investigator (such as severe pulmonary, neurological, or musculoskeletal disease) * Inability to give informed consent. Exclusion criteria for MRI: * Some metallic implants * Claustrophobia Exclusion criteria for muscle biopsy: * Treatment with either two antiplatelet drugs (aspirin and ADP-receptor antagonists) * Anticoagulants (warfarin, NOACs)
Where this trial is running
Aarhus, Jutland
- Aarhus University Hospital — Aarhus, Jutland, Denmark (Recruiting)
Study contacts
- Principal investigator: Henrik Wiggers, DMSC PHD MD — Dept. of Cardiology, Aarhus University Hospital
- Study coordinator: Thomas H Jensen, MD
- Email: thj@clin.au.dk
- Phone: 0045 20524213
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.