Ischemic Heart DiseasePhase 2PolyCADNCT06186102
Polyamine Treatment in Elderly Patients With Coronary Artery Disease
A Phase 2 study testing Spermidine in people with Ischemic Heart Disease and Myocardial Infarction, run by University of Aarhus at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 90 years
- Conditions the study is for
- Ischemic Heart Disease, Myocardial Infarction, Cardiovascular Diseases
- What is being tested?
- Spermidine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 187 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jan 2024to 29 Jun 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 90 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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),
Show all 10Show fewer
- Hypertension,
- Previous LVEF < 40%,
- Left atrial volume index ≥ 30 mL/m2
- Left ventricular wall thickness ≥ 1.1 cm.
Who cannot join
- 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
Show all 12Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Polyamine Treatment in Elderly Patients With Coronary Artery Disease - a Randomized Controlled Trial
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.
Read the 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 therefore of paramount importance to further promote longevity and quality of life.
In humans, a high concentration of whole-blood spermidine is associated with longevity, and individuals with a high dietary spermidine intake have improved cardiovascular health and less obesity. Spermidine is essentially a polyamine found in all plant-derived foods, particularly in whole grains, soybeans, nuts, and fruit. Its favorable effects may act via several mechanisms. In an experimental model of hypertensive heart disease, spermidine reduced cardiac hypertrophy and improved diastolic and mitochondrial function. Spermidine also induces cytoprotective autophagy in skeletal muscle and alters body fat accumulation by metabolically modulating glucose and lipid metabolism.
The clinical data on spermidine dietary supplementation are scarce. In elderly subjects with cognitive problems, spermidine supplement was well tolerated and had potential blood-pressure-lowering effects. The reported beneficial effects of spermidine raise the question whether elderly patients with cardiovascular disease can benefit from a dietary supplement of this polyamine.
The central hypothesis of the current proposal is that a twelve-month spermidine treatment regimen in elderly patients with cardiovascular disease will yield positive effects on heart and skeletal muscle function, whole body composition and inflammation. The secondary hypotheses are that spermidine reduces blood pressure and has a beneficial impact on cognitive function, daily activity level, quality of life, biomarker risk profile, skeletal muscle cellular metabolism and lastly but not least gut microbiota.
The study design is a randomized, double-blind, placebo-controlled trial to investigate the effects of a 24 mg daily oral spermidine dietary supplement vs. matching placebo in elderly patients with cardiovascular disease. A total of 200 patients will be included and randomized 1:1 to either spermidine 24 mg x 1 daily or matching placebo for one year.
At baseline and after one year of intervention the patients will undergo study procedures. Changes from baseline to follow-up will be compared between the active and placebo treated patient groups.
- Conditions
- Ischemic Heart Disease, Myocardial Infarction, Cardiovascular Diseases, Hypertensive Heart Disease, Hypertension, Diastolic Dysfunction
- Being tested
- Spermidine, Placebo
- Keywords
- Spermidine, Dietary supplement, Polyamine, Prevention, Treatment, Lifestyle, Coronary artery disease, Ischemic heart disease, Cardiovascular disease, Heart disease, Hypertension, Obesity, Diabetes Mellitus, Type 2, Insulin resistance, Inflammation, Quality of life, Cognitive function, Memory, Autophagy
- Medical subject headings
- Myocardial Ischemia, Myocardial Infarction, Cardiovascular Diseases, Hypertension, Obesity, Metabolic Syndrome, Diabetes Mellitus, Type 2, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpermidineDietary supplement
Also called Polyamine
Spermidine capsule of 8 mg x 3 capsules daily.
PlaceboOther
Placebo capsule. 3 capsules daily.
| Study group | Role | What they receive |
|---|---|---|
| Spermidine | Active comparator | Spermidine will be given orally as capsules of cellulose with spermidine (24 mg/day) and rice flour. Receives: 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) Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in left ventricular mass
Measured with Cardiac Magnetic Resonance Imaging (CMR).
Measured: 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.
Measured: From randomization (month 0) to 12 months
Change in High-sensitivity C-reactive Protein (hs-CRP)
Measured from blood samples.
Measured: 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.
Measured: From randomization (month 0) to 12 months
Secondary outcomes (35)
Muscle strength, Handgrip strength
Hand-held dynamometer for measuring handgrip strength in kilograms.
Measured: From randomization (month 0) to 12 months
Muscle strength, Knee-extension/flexion strength
Change in knee extension and flexion isokinetic strength (assessed by peak torque, Nm) and isometric strength (assessed by peak torque, Nm).
Measured: From randomization (month 0) to 12 months
Physical performance, 6 minute walk test (6MWT)
Change in walking distance in meters.
Measured: From randomization (month 0) to 12 months
Physical performance, 30 seconds sit to stand test
Change in counts of sit to stand.
Measured: From randomization (month 0) to 12 months
The Short Physical Performance Battery
Changes in points.
Measured: From randomization (month 0) to 12 months
Skeletal muscle mass
Thigh muscle mass by Magnetic Resonance Imaging (MRI) using Dixon method.
Measured: From randomization (month 0) to 12 months
Skeletal muscle cross sectional area (CSA) of fibers
CSA of fibers by cryosection of skeletal muscle biopsy obtained from vastus lateralis muscle.
Measured: From randomization (month 0) to 12 months
Skeletal muscle tissue fiber composition
Change in ratio between muscle fiber types (type I, IIa and IIb) assessed by immunohistochemistry.
Measured: From randomization (month 0) to 12 months
Skeletal muscle tissue cellular composition
Change in muscle tissue cellular composition assessed by cell sorting
Measured: From randomization (month 0) to 12 months
Skeletal muscle mitochondrial function
Change in muscle mitochondrial function assessed by high-resolution respirometry
Measured: From randomization (month 0) to 12 months
Total lean body mass
Change in lean body mass (in grams) and total lean mass/height^2.
Measured: From randomization (month 0) to 12 months
Total body fat percentage
Changes in body fat percentage.
Measured: From randomization (month 0) to 12 months
Estimated visceral adipose tissue
Change in VAT index (kilogram-per-meters-squared index) and in mass (in grams).
Measured: From randomization (month 0) to 12 months
Intramuscular and intermuscular fat content
Calculating thigh adipose tissue mass located between and within muscle fibers by MRI Dixon method.
Measured: From randomization (month 0) to 12 months
Free fatty acids
Measured from blood samples.
Measured: From randomization (month 0) to 12 months
Insulin resistance
Changes in insulin resistance assessed by Homeostatic Model Assessment for Insulin Resistance (HOMA-IR).
Measured: From randomization (month 0) to 12 months
Markers of autophagy
Proteomics of skeletal muscle tissue and peripheral blood mononuclear cells (PBMCs).
Measured: From randomization (month 0) to 12 months
Polyamine content in muscle biopsy
Measured with liquid chromatography mass spectrometry (LC-MS).
Measured: From randomization (month 0) to 12 months
Polyamine content in blood
Plasma samples obtained from blood. Measured with liquid chromatography mass spectrometry (LC-MS).
Measured: From randomization (month 0) to 12 months
Change in 24-hour ambulatory blood pressure measurements (24h ABPM)
Measured with the Spacelabs Healthcare 90217A device in an out-of-hospital setting.
Measured: From randomization (month 0) to 12 months
Change in central blood pressure
Measured noninvasive with pulse wave analysis (PWA) using a SphygmoCor system.
Measured: From randomization (month 0) to 12 months
Change in daily physical activity
Assessed by 14-day activity monitoring with an accelerometer (AX3, Axivity).
Measured: From randomization (month 0) to 12 months
Change in cardiac extracellular volume fraction
Assessed using Cardiac Magnetic Resonance Imaging (CMR) with intravenous gadolinium-based agent.
Measured: From randomization (month 0) to 12 months
Change in myocardial strain
Assessed using Cardiac Magnetic Resonance Imaging (CMR) with intravenous gadolinium-based agent.
Measured: From randomization (month 0) to 12 months
Change in Carotid-femoral pulse wave velocity
Measured non-invasively through applanation tonometry using a SphygmoCor system. The unit of measure is m/s.
Measured: From randomization (month 0) to 12 months
Change in Aortic pulse wave velocity
Magnetic resonance imaging (MRI) assessment. The unit of measure is m/s.
Measured: From randomization (month 0) to 12 months
Change in general cognitive function and memory performance
Evaluated using the Montreal Cognitive Assessment (MoCA). It will be administered in a clinical setting using a tablet. MoCA score ranges from 0-30 and a score of 26 or higher is considered normal.
Measured: From randomization (month 0) to 12 months
Change in specific domains of cognitive function
Evaluated using Cambridge Cognition (CANTAB) digital assessment software in a clinical setting using a tablet. The cognitive tests are MOT, RTI, SWM, DMS and PAL. These tests will objectively measure psychomotor speed, executive function and memory.
Measured: From randomization (month 0) to 12 months
HeartQol
HeartQol measures health-related quality of life (HRQL) and is a disease-specific health status instrument for ischemic heart disease. It consists of 14 items and provides two subscales; a 10-item physical subscale and a 4-item emotional subscale, which are scored on a four-point Likert scale (0 to 3). Higher scores indicate a better HRQL. Measured as global, physical and emotional score.
Measured: From randomization (month 0) to 12 months
Cytokines
Changes in cytokines are evaluated through the utilization of multiplex cytokine assays. Measured from plasma blood samples.
Measured: From randomization (month 0) to 12 months
White blood cells
Changes in white blood cell differential count.
Measured: From randomization (month 0) to 12 months
Immune cells
Changes in specific immune cell populations are measured using peripheral blood mononuclear cells (PBMCs) isolated from blood samples.
Measured: From randomization (month 0) to 12 months
Vascular inflammatory markers
Measured from plasma blood samples with a multiplex assay.
Measured: From randomization (month 0) to 12 months
Time to first occurrence of Composite cardiovascular endpoint: Cardiovascular death, heart failure hospitalizations, non-fatal myocardial infarction, non-fatal stroke, and coronary revascularization
Measured in months.
Measured: From randomization (month 0) to 12 months
Days alive and out of hospital
Measured in months.
Measured: From randomization (month 0) to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2023
- Study start1 Jan 2024
- Primary completion29 Jun 2026
- Study completion29 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ischemic Heart DiseaseStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blind, placebo-controlled, two-armed, parallel-group, single centre, clinical study.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 187 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Sygesikringen Danmark, Aarhus University Hospital, Danish Diabetes Academy, Danish Cardiovascular Academy (DCA), Eva and Henry Frænkels Mindefond, DoNotAge.org
- Responsible party
- Sponsor
- Investigators
- Henrik Wiggers, DMSC PHD MD, Principal investigator, Dept. of Cardiology, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06186102
- Sponsor's protocol ID
- M-2023-71-23
- Acronym
- PolyCAD
- Status last verified
- Apr 2026
- First submitted
- 7 Dec 2023
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Thorup C, Jensen TH, Jeppesen CNA, Tinggaard AB, Johannsen M, Hansen J, Hvas CL, Rud CL, Wang J, Farup J, Jessen N, Wiggers H. Spermidine and spermine in elderly patients with coronary artery disease: a cross-sectional study of dietary intake and plasma and skeletal muscle concentrations. Clin Nutr. 2026 Jun;61:106651. doi: 10.1016/j.clnu.2026.106651. Epub 2026 Apr 3.
PubMed 42000692Thorup 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.
PubMed 41168834
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Polyamine Treatment in Elderly Patients With Coronary Artery Disease - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06186102
- Acronym / sponsor ID
- PolyCAD / M-2023-71-23
- Conditions
- Ischemic Heart Disease, Myocardial Infarction, Cardiovascular Diseases, Hypertensive Heart Disease, Hypertension, Diastolic Dysfunction
- Keywords
- Spermidine, Dietary supplement, Polyamine, Prevention, Treatment, Lifestyle, Coronary artery disease, Ischemic heart disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 187 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Sygesikringen Danmark, Aarhus University Hospital, Danish Diabetes Academy, Danish Cardiovascular Academy (DCA), Eva and Henry Frænkels Mindefond, DoNotAge.org
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 29 Jun 2026 (actual)
- Study completion
- 29 Jun 2026 (actual)
- First posted
- 29 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 therefore of paramount importance to further promote longevity and quality of life.
In humans, a high concentration of whole-blood spermidine is associated with longevity, and individuals with a high dietary spermidine intake have improved cardiovascular health and less obesity. Spermidine is essentially a polyamine found in all plant-derived foods, particularly in whole grains, soybeans, nuts, and fruit. Its favorable effects may act via several mechanisms. In an experimental model of hypertensive heart disease, spermidine reduced cardiac hypertrophy and improved diastolic and mitochondrial function. Spermidine also induces cytoprotective autophagy in skeletal muscle and alters body fat accumulation by metabolically modulating glucose and lipid metabolism.
The clinical data on spermidine dietary supplementation are scarce. In elderly subjects with cognitive problems, spermidine supplement was well tolerated and had potential blood-pressure-lowering effects. The reported beneficial effects of spermidine raise the question whether elderly patients with cardiovascular disease can benefit from a dietary supplement of this polyamine.
The central hypothesis of the current proposal is that a twelve-month spermidine treatment regimen in elderly patients with cardiovascular disease will yield positive effects on heart and skeletal muscle function, whole body composition and inflammation. The secondary hypotheses are that spermidine reduces blood pressure and has a beneficial impact on cognitive function, daily activity level, quality of life, biomarker risk profile, skeletal muscle cellular metabolism and lastly but not least gut microbiota.
The study design is a randomized, double-blind, placebo-controlled trial to investigate the effects of a 24 mg daily oral spermidine dietary supplement vs. matching placebo in elderly patients with cardiovascular disease. A total of 200 patients will be included and randomized 1:1 to either spermidine 24 mg x 1 daily or matching placebo for one year.
At baseline and after one year of intervention the patients will undergo study procedures. Changes from baseline to follow-up will be compared between the active and placebo treated patient groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, double-blind, placebo-controlled, two-armed, parallel-group, single centre, clinical study.
| Arm | Type | Receives |
|---|---|---|
| Spermidine | Active comparator | Dietary Supplement: SpermidineSpermidine will be given orally as capsules of cellulose with spermidine (24 mg/day) and rice flour. |
| Placebo | Placebo comparator | Other: PlaceboPlacebo will be given orally as capsules of cellulose and rice flour (same size and visual appearance as spermidine capsules) |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (10 listed)
- Age ≥ 65 years
- Chronic ischemic heart disease (previous revascularization or myocardial infarction)
- Left ventricular ejection fraction of > 40%
- Type 2 diabetes,
- Obesity (BMI ≥ 30 kg/m2),
Key exclusion criteria (12 listed)
- Unstable coronary syndrome
- Significant and severe cardiac valve disease
- Severe peripheral artery disease
- Permanent atrial fibrillation
- Pacemaker treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SpermidineAlso: PolyamineSpermidine capsule of 8 mg x 3 capsules daily. | Dietary supplement | Spermidine |
| PlaceboPlacebo capsule. 3 capsules daily. | Other | Placebo |
Primary outcome
Change in left ventricular mass
Time frame: From randomization (month 0) to 12 months
Measured with Cardiac Magnetic Resonance Imaging (CMR).
Change in appendicular lean mass and ALM index
Time frame: From randomization (month 0) to 12 months
Appendicular lean mass and ALM index (Appendicular lean mass/height^2). Measured by a whole-body dual-energy X ray absorptiometry (DXA) scan.
Change in High-sensitivity C-reactive Protein (hs-CRP)
Time frame: From randomization (month 0) to 12 months
Measured from blood samples.
Change in Physical performance, peak oxygen consumption (VO2max)
Time frame: From randomization (month 0) to 12 months
Measured by cardiopulmonary exercise capacity (CPET) will be performed using a cycle ergometer test. Peak oxygen uptake measured in ml O2/kg/min.
35 secondary outcomes
Muscle strength, Handgrip strength
Time frame: From randomization (month 0) to 12 months
Muscle strength, Knee-extension/flexion strength
Time frame: From randomization (month 0) to 12 months
Physical performance, 6 minute walk test (6MWT)
Time frame: From randomization (month 0) to 12 months
Physical performance, 30 seconds sit to stand test
Time frame: From randomization (month 0) to 12 months
The Short Physical Performance Battery
Time frame: From randomization (month 0) to 12 months
Skeletal muscle mass
Time frame: From randomization (month 0) to 12 months
Skeletal muscle cross sectional area (CSA) of fibers
Time frame: From randomization (month 0) to 12 months
Skeletal muscle tissue fiber composition
Time frame: From randomization (month 0) to 12 months
Skeletal muscle tissue cellular composition
Time frame: From randomization (month 0) to 12 months
Skeletal muscle mitochondrial function
Time frame: From randomization (month 0) to 12 months
Total lean body mass
Time frame: From randomization (month 0) to 12 months
Total body fat percentage
Time frame: From randomization (month 0) to 12 months
Estimated visceral adipose tissue
Time frame: From randomization (month 0) to 12 months
Intramuscular and intermuscular fat content
Time frame: From randomization (month 0) to 12 months
Free fatty acids
Time frame: From randomization (month 0) to 12 months
Insulin resistance
Time frame: From randomization (month 0) to 12 months
Markers of autophagy
Time frame: From randomization (month 0) to 12 months
Polyamine content in muscle biopsy
Time frame: From randomization (month 0) to 12 months
Polyamine content in blood
Time frame: From randomization (month 0) to 12 months
Change in 24-hour ambulatory blood pressure measurements (24h ABPM)
Time frame: From randomization (month 0) to 12 months
Change in central blood pressure
Time frame: From randomization (month 0) to 12 months
Change in daily physical activity
Time frame: From randomization (month 0) to 12 months
Change in cardiac extracellular volume fraction
Time frame: From randomization (month 0) to 12 months
Change in myocardial strain
Time frame: From randomization (month 0) to 12 months
Change in Carotid-femoral pulse wave velocity
Time frame: From randomization (month 0) to 12 months
Change in Aortic pulse wave velocity
Time frame: From randomization (month 0) to 12 months
Change in general cognitive function and memory performance
Time frame: From randomization (month 0) to 12 months
Change in specific domains of cognitive function
Time frame: From randomization (month 0) to 12 months
HeartQol
Time frame: From randomization (month 0) to 12 months
Cytokines
Time frame: From randomization (month 0) to 12 months
White blood cells
Time frame: From randomization (month 0) to 12 months
Immune cells
Time frame: From randomization (month 0) to 12 months
Vascular inflammatory markers
Time frame: From randomization (month 0) to 12 months
Time to first occurrence of Composite cardiovascular endpoint: Cardiovascular death, heart failure hospitalizations, non-fatal myocardial infarction, non-fatal stroke, and coronary revascularization
Time frame: From randomization (month 0) to 12 months
Days alive and out of hospital
Time frame: From randomization (month 0) to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Derived from this study: PubMed 42000692Thorup C, Jensen TH, Jeppesen CNA, Tinggaard AB, Johannsen M, Hansen J, Hvas CL, Rud CL, Wang J, Farup J, Jessen N, Wiggers H. Spermidine and spermine in elderly patients with coronary artery disease: a cross-sectional study of dietary intake and plasma and skeletal muscle concentrations. Clin Nutr. 2026 Jun;61:106651. doi: 10.1016/j.clnu.2026.106651. Epub 2026 Apr 3.
- Derived from this study: PubMed 41168834Thorup 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henrik Wiggers, DMSC PHD MD principal investigator
Dept. of Cardiology, Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Spermidine in people with Ischemic Heart Disease and Myocardial Infarction, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in left ventricular mass (time frame: From randomization (month 0) to 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06186102, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.