Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruiting
Participants planned
278
Countries
1
Sites
1
Aortic stenosis
This study is intended to investigate the effect of angiotensin receptor blockers on mild to moderate aortic stenosis.
Key facts
- Sponsor
- Odense University Hospital
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- 30 Jan 2025 → ongoing
- Decision date (initial)
- 2025-01-30
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-518389-28-00
- EudraCT number
- 2018-004653-24
- ClinicalTrials.gov
- NCT04913870
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Safety, Prophylaxis, Therapy
This study is intended to investigate the effect of angiotensin receptor blockers on mild to moderate aortic stenosis.
Secondary objectives 1
- To compare the safety (pre-specified side-effects) of angiotensin-receptor-blocker (Losartan) compared to placebo
Conditions and MedDRA coding
Aortic stenosis
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Patients with mild-moderate aortic stenosis (peak aortic jet velocity ≥2.5 and <4m/s).
- Age ≥ 20 ≤ 85 years
- Left ventricular ejection fraction ≥50%
- Systolic blood pressure ≥100 mmHg
- Signed informed consent
Exclusion criteria 8
- More than mild aortic or mitral regurgitation, or mitral stenosis
- Current use of renin-angiotensin system medication or Aliskiren in patiens with arterial hypertension and diabetes mellitus or arterial hypertension and chronic kidney disease stage 4-5 (estimated glomerular filtration rate <30 ml/min/1.73m2)
- Known allergy or intolerance to Angiotensin-receptor-blockers, poorly controlled blood pressure
- Renal dysfunction (glomerular filtration rate <30ml/min/1.73 m2) or chronic hyperkalemia (P-potassium ≥5.5 mmol/l)
- Hepatic failure, cirrhosis, hepatitis or history of hepatic impairment
- Newly diagnosed (<2 months) or poorly controlled diabetes; HbA1c >86 mmol/mol (>10%)
- Pre-existing obstructive coronary artery disease with CCS III-IV angina or recent myocardial infarction (<3 months)
- Pregnant or lactating women. Fertile women without highly effective birth control method. Patients unable to read, understand or sign research consent
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- The rate of progression of peak aortic velocity (m/s) assessed by echocardiography
- The rate of progression of aortic valve calcification (AU) assessed by non-contrast computed tomography after 24 months treatment with losartan compared with placebo.
Secondary endpoints 3
- Left ventricular geometry and mass (relative wall-thickness, left ventricular mass index) assessed by echocardiography and magnetic resonance imaging after 24 months treatment with losartan compared with placebo treatment.
- Diastolic function assessed by echocardiography
- Markers of left ventricular filling pressures (E/e’, NT-proBNP)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SUB02974MIG · Substance
- Active substance
- Losartan Potassium
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 50 mg milligram(s)
- Max total dose
- 36500 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
SUB21402 · Substance
- Active substance
- Placebo
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Odense University Hospital
- Sponsor organisation
- Odense University Hospital
- Address
- J B Winsloews Vej 4
- City
- Odense C
- Postcode
- 5000
- Country
- Denmark
Scientific contact point
- Organisation
- Odense University Hospital
- Contact name
- Mulham Ali
Public contact point
- Organisation
- Odense University Hospital
- Contact name
- Mulham Ali
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Odense University Hospital ORG-100007716
|
Odense C, Denmark | On site monitoring, E-data capture, Code 8 |
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ongoing, recruiting | 139 | 1 |
| Rest of world
Canada
|
— | 139 | — |
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 | 2025-01-30 | 2025-01-30 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 6 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2018-004653-24 | 6.0 |
| Recruitment arrangements (for publication) | Placeholder Recruitment arrangements_CTA 2024-518389-28-00 | 1 |
| Subject information and informed consent form (for publication) | K2_Deltagerinformation om deltagelse i et videnskabeligt lgemiddelforsg | 7 |
| Subject information and informed consent form (for publication) | K2_samtykkeerklring | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Losartan | 1 |
| Synopsis of the protocol (for publication) | D2_Protokolresume_2018-004653-24 | 6 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-01-14 | Denmark | Acceptable 2025-01-29
|
2025-01-30 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-04-10 | Denmark | Acceptable 2025-01-29
|
2026-04-10 |