2023-509804-14-00RecruitingPhase 4
The role of meldonium and individualized physical activities in the treatment of patients with heart failure
Source: EU CTIS (euclinicaltrials.eu) · Last updated 27 Mar 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
To evaluate effectiveness of meldonium and individualised physical activity recommendations in patients with heart failure with preserved ejection fraction.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 8 Dec 2023
- Start date
- 19 Jun 2024
- Lead sponsor
- Pauls Stradins Clinical University Hospital
- Diseases
- Heart failure
- EU CT number
- 2023-509804-14-00
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 200
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with long-term heart failure with preserved ejection fraction. It tests meldonium and individual physical activity advice.
- Age
- 18 years or older
- Sex
- Men and women
- Disease stage
- Chronic heart failure, NYHA class II-III. Left ventricle ejection fraction above 50 and LAVI above 34 ml/m2 on echocardiography.
- Earlier treatment
- On optimal medical therapy for at least 3 months. A coronary angiography or computed coronary angiography was done to rule out obstructive coronary artery disease. No digoxin, trimetazidine, ranolazine, meldonium or ivabradine. No coronary revascularisation within 3 months.
Main reasons for not taking part
- Allergic reaction to meldonium
- Iron deficiency anemia
- Severe kidney or liver disease
- Congenital heart disease, or moderate to severe heart valve disease
- Pregnant or breastfeeding women
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Other illness
- Allergic reaction to meldonium
- Congenital heart diseases
- Moderate to severe cardiac valve diseases
Lab values
- Iron deficiency anemia (men Hb < 13 g/dL, women Hb <12 g/dl un serum ferritin levels < 30ng/ml or transferrin saturation ≤19 %)
Other
- Patient is involved in other trial
- Severe kindey or liver disfunction
- Pregnancy/breastfeeding women
- Patient uses digoxin, trimetazidine, ranolazine, meldonium, ivabradine
- Patient underwent coronary revascularisation within 3 months
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Pauls Stradins Clinical University Hospital | Riga | Latvia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.