Polyamine Treatment in Elderly Patients With Coronary Artery Disease (NCT06186102) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Polyamine Treatment in Elderly Patients With Coronary Artery Disease
Denmark180 participantsStarted 2024-01-01
Plain-language 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.
Who can participate
Age range
65 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in left ventricular mass
Timeframe: From randomization (month 0) to 12 months
2
Change in appendicular lean mass and ALM index
Timeframe: From randomization (month 0) to 12 months
3
Change in High-sensitivity C-reactive Protein (hs-CRP)
Timeframe: From randomization (month 0) to 12 months
4
Change in Physical performance, peak oxygen consumption (VO2max)
Timeframe: From randomization (month 0) to 12 months