Status:
ACTIVE_NOT_RECRUITING
Polyamine Treatment in Elderly Patients With Coronary Artery Disease
Lead Sponsor:
University of Aarhus
Collaborating Sponsors:
Sygesikringen Danmark
Steno Diabetes Center Aarhus (SDCA), Aarhus University Hospital
Conditions:
Ischemic Heart Disease
Myocardial Infarction
Eligibility:
All Genders
65-90 years
Phase:
PHASE2
Brief 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 centr...
Detailed Description
Life expectancy has increased tremendously over the past century and as populations age, chronic diseases such as cardiovascular disease and diabetes have become more prevalent. Healthy aging is there...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2027
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT06186102
Start Date
January 1 2024
End Date
January 1 2027
Last Update
November 18 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Aarhus University Hospital
Aarhus, Jutland, Denmark, 8200