Overview
Sponsor-declared trial summary
Chronic heart failure with preserved ejection fraction
To evaluate effectiveness of meldonium and individualised physical activity recommendations in patients with heart failure with preserved ejection fraction.
Key facts
- Sponsor
- Pauls Stradins Clinical University Hospital
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Decision date (initial)
- 2024-03-27
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Prophylaxis
To evaluate effectiveness of meldonium and individualised physical activity recommendations in patients with heart failure with preserved ejection fraction.
Conditions and MedDRA coding
Chronic heart failure with preserved ejection fraction
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Chronic heart failure II - III functional class NYHA (The New York Heart Association)
- In transthoracic echocardiography calculated left ventricle ejection fraction >50 un LAVI >34 ml/m2.
- Patient receives optimal medical therapy for at least 3 months.
- Coronary angiography or computed coronary angiography has been done to rule out obstructive coronary artery disease
- Patients ≥18 years
Exclusion criteria 9
- Allergic reaction to meldonium
- Patient is involved in other trial
- Iron deficiency anemia (men Hb < 13 g/dL, women Hb <12 g/dl un serum ferritin levels < 30ng/ml or transferrin saturation ≤19 %)
- Severe kindey or liver disfunction
- Congenital heart diseases
- Moderate to severe cardiac valve diseases
- Pregnancy/breastfeeding women
- Patient uses digoxin, trimetazidine, ranolazine, meldonium, ivabradine
- Patient underwent coronary revascularisation within 3 months
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Physical activity tolerance change asessed by the cardiopulmonary test (relative maximal oxygen uptake, VO2 max ml/min/kg)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SUB30147 · Substance
- Active substance
- Meldonium
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL
- Max daily dose
- 1000 mg milligram(s)
- Max total dose
- 1000 mg milligram(s)
- Max treatment duration
- 6 Week(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
Pauls Stradins Clinical University Hospital
- Sponsor organisation
- Pauls Stradins Clinical University Hospital
- Address
- Pilsonu Iela 13
- City
- Riga
- Postcode
- 1002
- Country
- Latvia
Scientific contact point
- Organisation
- Pauls Stradins Clinical University Hospital
- Contact name
- Head of clinical trials
Public contact point
- Organisation
- Pauls Stradins Clinical University Hospital
- Contact name
- Head of clinical trials
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Latvia | Authorised, recruitment pending | 200 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-12-08 | Latvia | Acceptable 2024-03-25
|
2024-03-27 |