Overview
Sponsor-declared trial summary
Heart failure
To visualize and quantify pyruvate metabolism of the heart in patients with heart disease and correlate it to current clinical diagnostic scanning modalities.
Key facts
- Sponsor
- Region Midtjylland
- Participant type
- Patients, Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14], Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
- Trial duration
- 1 Dec 2019 → ongoing
- Decision date (initial)
- 2024-09-16
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-515414-40-00
- EudraCT number
- 2018-003533-15
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Diagnosis
To visualize and quantify pyruvate metabolism of the heart in patients with heart disease and correlate it to current clinical diagnostic scanning modalities.
Conditions and MedDRA coding
Heart failure
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- Chronic heart failure (Heart failure with both reduced and preserved EF are allowed) > 18 years of age. Left ventricular Ejection Fraction (LVEF) of 10 – 60 % Adequate hematologic and organ function, i.e. ANC at least 1.500/uL Platelet count >100/uL Se creatinine up to 1.5 x UNL or creatinine clearance at least 30 ml/min Women who are not postmenopausal or surgically sterile must have a negative serum or urine pregnancy test performed at time of inclusion in the study. Safe and highly effective contraception must be used throughout the study meaning either hormonal anti-conception or an anti-fertility intrauterine device. If the partner is non fertile or the patient has no sexual activities, this is also accepted. Non-insulin dependent Diabetes mellitus is allowed Danish speaking Able and willing to comply after informed consent For substudy 1A only: Ischemic heart disease and referral to viability testing at the Department of Clinical Physiology and Nuclear Medicine at Aarhus University Hospital, Skejby.
Exclusion criteria 1
- Not able or willing to receive heart failure therapy Patients not willing to participate Uncontrolled serious medical condition, such as uncontrolled heart disease, uncontrolled diabetes, intestinal obstruction, uncontrolled hypertension, or recent cerebral ischemia Receiving more than 50% of taget dose of ACE-inhibitor and betablockers before inclusion in study 1 (this does not apply for substudy 1A) Estimated Glomerular Filtration Rate (eGFR) <30 mL/min Insulin dependent Diabetes Mellitus Intolerance to Pyruvate
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Metabolic in vivo flux through the PDC in the myocardium in humans. Co-primary endpoints are: a) [13C]-bicarbonate/[1-13C]-pyruvate ratio, b) [1-13C]-lactate / [1-13C]-pyruvate ratio and [1-13C]-lactate / [1-13C]-bicarbonate ratio. The latter gives ratio indices of PDC-mediated pyruvate oxidation and lactate production via lactate dehydrogenase.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Hyperpolarized [1-13C]pyruvate
PRD10284730 · Product
- Active substance
- Pyruvic Acid
- Pharmaceutical form
- INJECTION
- Route of administration
- IV INJECTION, IV INFUSION
- Authorisation status
- Not Authorised
- MA holder
- AARHUS UNIVERSITY
- Paediatric formulation
- No
- Orphan designation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Region Midtjylland
- Sponsor organisation
- Region Midtjylland
- Address
- Palle Juul-Jensens Boulevard 99
- City
- Aarhus N
- Postcode
- 8200
- Country
- Denmark
Scientific contact point
- Organisation
- Region Midtjylland
- Contact name
- Henrik Wiggers
Public contact point
- Organisation
- Region Midtjylland
- Contact name
- Henrik Wiggers
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Aarhus Universitet ORG-100028380
|
Aarhus N, Denmark | On site monitoring |
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ongoing, recruiting | 30 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Denmark | 2019-12-01 | 2019-12-06 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 7 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Protocol | 6 |
| Recruitment arrangements (for publication) | Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | Deltagerinformation Pilotstudie raske | 1 |
| Subject information and informed consent form (for publication) | Deltagerinformation Studie 1 og 2 | 1 |
| Subject information and informed consent form (for publication) | Deltagerinformation substudie 1A | 1 |
| Subject information and informed consent form (for publication) | Samtykkeerklring | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Pyruvic acid | 1 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-30 | Denmark | Acceptable 2024-09-16
|
2024-09-16 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-04-28 | Denmark | Acceptable 2024-09-16
|
2025-04-28 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-02-13 | Denmark | Acceptable 2024-09-16
|
2026-02-13 |