Polyamine Treatment in Elderly Patients With Coronary Artery Disease - a Randomized Controlled Trial
Status: Recruiting
Location: See location...
Intervention Type: Other, Dietary supplement
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
The present study is testing spermidine treatment in elderly patients with coronary artery disease. The study is a randomized, double-blind, placebo-controlled, two-armed, parallel-group, single centre, clinical study.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 65
Maximum Age: 90
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Denmark
Aarhus University Hospital
RECRUITING
Aarhus
Contact Information
Primary
Thomas H Jensen, MD
thj@clin.au.dk
0045 20524213
Backup
Christian V Thorup, MD
christian.thorup@clin.au.dk
Time Frame
Start Date: 2024-01-01
Estimated Completion Date: 2027-01
Participants
Target number of participants: 180
Treatments
Active_comparator: Spermidine
Spermidine will be given orally as capsules of cellulose with spermidine (24 mg/day) and rice flour.
Placebo_comparator: Placebo
Placebo will be given orally as capsules of cellulose and rice flour (same size and visual appearance as spermidine capsules)
Related Therapeutic Areas
Sponsors
Collaborators: Danish Cardiovascular Academy (DCA), Steno Diabetes Center Aarhus (SDCA), Aarhus University Hospital, Sygesikringen Danmark, DoNotAge.org, Danish Diabetes Academy, Eva and Henry Frænkels Mindefond
Leads: University of Aarhus