Phase 2 Completed NCT06186102

Polyamine Treatment in Elderly Patients With Coronary Artery Disease - a Randomized Controlled Trial

University of Aarhus · Interventional, Randomized

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Completed June 2026. Read the results summary below →
Study context Single-site study

Overview

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.

Full record on ClinicalTrials.gov (NCT ID NCT06186102).

Results summary

None

Outcome data

EndpointTypeResultSignificance
Change in left ventricular mass Primary None None
Change in appendicular lean mass and ALM index Primary None None
Change in High-sensitivity C-reactive Protein (hs-CRP) Primary None None
Change in Physical performance, peak oxygen consumption (VO2max) Primary None None
Muscle strength, Handgrip strength Secondary None None
Muscle strength, Knee-extension/flexion strength Secondary None None
Physical performance, 6 minute walk test (6MWT) Secondary None None
Physical performance, 30 seconds sit to stand test Secondary None None
The Short Physical Performance Battery Secondary None None
Skeletal muscle mass Secondary None None
Skeletal muscle cross sectional area (CSA) of fibers Secondary None None
Skeletal muscle tissue fiber composition Secondary None None
Skeletal muscle tissue cellular composition Secondary None None
Skeletal muscle mitochondrial function Secondary None None
Total lean body mass Secondary None None
Total body fat percentage Secondary None None
Estimated visceral adipose tissue Secondary None None
Intramuscular and intermuscular fat content Secondary None None
Free fatty acids Secondary None None
Insulin resistance Secondary None None
Markers of autophagy Secondary None None
Polyamine content in muscle biopsy Secondary None None
Polyamine content in blood Secondary None None
Change in 24-hour ambulatory blood pressure measurements (24h ABPM) Secondary None None
Change in central blood pressure Secondary None None
Change in daily physical activity Secondary None None
Change in cardiac extracellular volume fraction Secondary None None
Change in myocardial strain Secondary None None
Change in Carotid-femoral pulse wave velocity Secondary None None
Change in Aortic pulse wave velocity Secondary None None
Change in general cognitive function and memory performance Secondary None None
Change in specific domains of cognitive function Secondary None None
HeartQol Secondary None None
Cytokines Secondary None None
White blood cells Secondary None None
Immune cells Secondary None None
Vascular inflammatory markers Secondary None None
Time to first occurrence of Composite cardiovascular endpoint: Cardiovascular death, heart failure hospitalizations, non-fatal myocardial infarction, non-fatal stroke, and coronary revascularization Secondary None None
Days alive and out of hospital Secondary None None

Full results record on ClinicalTrials.gov.

Study design

Phase
Phase 2
Study type
Interventional
Allocation
Randomized
Masking
Quadruple-blind
Intervention model
Parallel assignment
Primary purpose
Treatment
Enrollment (final)
187 participants
Started
January 2024
Actually completed
June 2026

Recruitment criteria

Age range: 65–90 · Sex: All · Healthy volunteers: Requires diagnosis

Locationsi

1 site participated during the trial period. Representative sites shown below; full historical record on ClinicalTrials.gov.

Aarhus University Hospital — Aarhus, Jutland (Denmark)

Sources

REG
ClinicalTrials.gov — NCT06186102
Trial registry · primary record
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