Polyamine Treatment in Elderly Patients With Coronary Artery Disease

Launched by UNIVERSITY OF AARHUS · Dec 15, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called spermidine in older patients who have coronary artery disease, which is a condition that affects the heart's blood vessels. The goal is to see if this treatment can improve heart health and overall well-being in people aged 65 and older who have a history of heart issues, such as previous heart attacks or surgeries to improve blood flow. To participate, individuals must have a specific level of heart function and at least two risk factors, such as type 2 diabetes, obesity, or high blood pressure.

Participants in the trial can expect to be randomly assigned to either receive the spermidine treatment or a placebo (a look-alike treatment with no active ingredients) without knowing which one they are getting. This helps ensure the study's results are fair and reliable. It’s important to note that certain serious health conditions, like severe heart problems or kidney disease, may prevent someone from participating. Overall, this study aims to find new ways to help improve heart health in older adults, which can lead to better quality of life.

Gender

ALL

Eligibility 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)