NCT06186102

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 centre, clinical study.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for phase_2

Timeline
8mo left

Started Jan 2024

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress78%
Jan 2024Jan 2027

First Submitted

Initial submission to the registry

December 7, 2023

Completed
22 days until next milestone

First Posted

Study publicly available on registry

December 29, 2023

Completed
3 days until next milestone

Study Start

First participant enrolled

January 1, 2024

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

November 18, 2025

Status Verified

November 1, 2024

Enrollment Period

2.5 years

First QC Date

December 7, 2023

Last Update Submit

November 14, 2025

Conditions

Ischemic Heart DiseaseMyocardial InfarctionCardiovascular DiseasesHypertensive Heart DiseaseHypertensionDiastolic DysfunctionObesityMetabolic SyndromeDiabetes Mellitus, Type 2Dietary HabitsInflammationQuality of LifeCognition DisorderCognitive Impairment

Keywords

SpermidineDietary supplementPolyaminePreventionTreatmentLifestyleCoronary artery diseaseIschemic heart diseaseCardiovascular diseaseHeart diseaseHypertensionObesityDiabetes Mellitus, Type 2Insulin resistanceInflammationQuality of lifeCognitive functionMemoryAutophagy

Outcome Measures

Primary Outcomes (4)

  • Change in left ventricular mass

    Measured with Cardiac Magnetic Resonance Imaging (CMR).

    From randomization (month 0) to 12 months

  • Change in appendicular lean mass and ALM index

    Appendicular lean mass and ALM index (Appendicular lean mass/height\^2). Measured by a whole-body dual-energy X ray absorptiometry (DXA) scan.

    From randomization (month 0) to 12 months

  • Change in High-sensitivity C-reactive Protein (hs-CRP)

    Measured from blood samples.

    From randomization (month 0) to 12 months

  • Change in Physical performance, peak oxygen consumption (VO2max)

    Measured by cardiopulmonary exercise capacity (CPET) will be performed using a cycle ergometer test. Peak oxygen uptake measured in ml O2/kg/min.

    From randomization (month 0) to 12 months

Secondary Outcomes (35)

  • Muscle strength, Handgrip strength

    From randomization (month 0) to 12 months

  • Muscle strength, Knee-extension/flexion strength

    From randomization (month 0) to 12 months

  • Physical performance, 6 minute walk test (6MWT)

    From randomization (month 0) to 12 months

  • Physical performance, 30 seconds sit to stand test

    From randomization (month 0) to 12 months

  • The Short Physical Performance Battery

    From randomization (month 0) to 12 months

  • +30 more secondary outcomes

Other Outcomes (8)

  • Changes in gut microbiota

    From randomization (month 0) to 12 months

  • Changes in fecal metabolites

    From randomization (month 0) to 12 months

  • Skeletal muscle quality assesment

    From randomization (month 0) to 12 months

  • +5 more other outcomes

Study Arms (2)

Spermidine

ACTIVE COMPARATOR

Spermidine will be given orally as capsules of cellulose with spermidine (24 mg/day) and rice flour.

Dietary Supplement: Spermidine

Placebo

PLACEBO COMPARATOR

Placebo will be given orally as capsules of cellulose and rice flour (same size and visual appearance as spermidine capsules)

Other: Placebo

Interventions

SpermidineDIETARY_SUPPLEMENT

Spermidine capsule of 8 mg x 3 capsules daily.

Also known as: Polyamine
Spermidine
PlaceboOTHER

Placebo capsule. 3 capsules daily.

Placebo

Eligibility Criteria

Age65 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • Some metallic implants
  • Claustrophobia
  • Treatment with either two antiplatelet drugs (aspirin and ADP-receptor antagonists)
  • Anticoagulants (warfarin, NOACs)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University Hospital

Aarhus, Jutland, 8200, Denmark

Location

Related Publications (1)

  • Thorup CV, Jeppesen CNA, Jensen TH, Tinggaard AB, Hvas CL, Rud CL, Skou MK, Mortensen JK, Reggiori F, Dengjel J, Wang J, Farup J, Jessen N, Kim WY, Wiggers H. POLYamine treatment in elderly patients with Coronary Artery Disease (POLYCAD): study protocol for a Danish randomised, double-blind, placebo-controlled trial of spermidine treatment versus placebo. Trials. 2025 Oct 30;26(1):452. doi: 10.1186/s13063-025-09176-z.

    PMID: 41168834DERIVED

MeSH Terms

Conditions

Myocardial IschemiaMyocardial InfarctionCardiovascular DiseasesHypertensionObesityMetabolic SyndromeDiabetes Mellitus, Type 2Feeding BehaviorInflammationCognition DisordersCognitive DysfunctionCoronary Artery DiseaseHeart DiseasesInsulin Resistance

Interventions

SpermidinePolyamines

Condition Hierarchy (Ancestors)

Vascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesDiabetes MellitusEndocrine System DiseasesBehavior, AnimalBehaviorNeurocognitive DisordersMental DisordersCoronary DiseaseArteriosclerosisArterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

PutrescineBiogenic PolyaminesBiogenic AminesAminesOrganic Chemicals

Study Officials

  • Henrik Wiggers, DMSC PHD MD

    Dept. of Cardiology, Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Double (Participant, Investigator)
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized, double-blind, placebo-controlled, two-armed, parallel-group, single centre, clinical study.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2023

First Posted

December 29, 2023

Study Start

January 1, 2024

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

January 1, 2027

Last Updated

November 18, 2025

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)