Clinical trial • Phase IV • Cardiology

MELDONIUM for Heart failure with preserved ejection fraction

Phase IV trial of MELDONIUM for Heart failure with preserved ejection fraction. 200 participants.

Overview

Phase IV trial across 1 site in Latvia.

Recruits 200 Vulnerable population selected: true. No further details on consent or assent handling are provided in the record..

Pregnancy Exclusion: Pregnancy/breastfeeding women
Vulnerable Population: Vulnerable population selected: true. No further details on consent or assent handling are provided in the record.

{"criterion_text":"- Chronic heart failure II - III functional class NYHA (The New York Heart Association)\n- In transthoracic echocardiography calculated left ventricle ejection fraction >50 un LAVI >34 ml/m2.\n- Patient receives optimal medical therapy for at least 3 months.\n- Coronary angiography or computed coronary angiography has been done to rule out obstructive coronary artery disease\n- Patients ≥18 years"}

{"criterion_text":"- Allergic reaction to meldonium\n- Patient is involved in other trial\n- Iron deficiency anemia (men Hb < 13 g/dL, women Hb <12 g/dl un serum ferritin levels < 30ng/ml or transferrin saturation ≤19 %)\n- Severe kindey or liver disfunction\n- Congenital heart diseases\n- Moderate to severe cardiac valve diseases\n- Pregnancy/breastfeeding women\n- Patient uses digoxin, trimetazidine, ranolazine, meldonium, ivabradine\n- Patient underwent coronary revascularisation within 3 months"}

{"endpoint_text":"- Physical activity tolerance change asessed by the cardiopulmonary test (relative maximal oxygen uptake, VO2 max ml/min/kg)","definition_or_measurement_approach":"Assessed by the cardiopulmonary test measuring relative maximal oxygen uptake (VO2 max ml/min/kg)."}

Investigational Product Name: MELDONIUM
Active Substance: MELDONIUM
Modality: Small molecule
Routes Of Administration: ORAL
Route: ORAL
Authorisation Status: Approved for chronic heart failure (as stated in trial justification)
Maximum Dose: 1000 mg (max daily dose amount 1000 mg)

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