Authorised Therapeutic use (Phase IV) Chronic heart failure with preserved ejection fraction

The role of meldonium and individualized physical activities in the treatment of patients with heart failure

EU CTIS ID: 2023-509804-14-00

What this study is testing

To evaluate effectiveness of meldonium and individualised physical activity recommendations in patients with heart failure with preserved ejection fraction.

  • Therapeutic use (Phase IV)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • 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

You likely can't join if

  • 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
See the full eligibility criteria
Who can join
  • 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
What rules you out
  • 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

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.