2023-508118-40-01招募中2 期
A Phase 2 Proof-of-Concept clinical trial to quantify myocardial manganese uptake rate by cardiovascular magnetic resonance imaging following mangafodipir trisodium administration in healthy volunteers and heart failure patients with preserved ejection fraction caused by hypertrophic cardiomyopathy or cardiac amyloidosis.
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Primary endpoint: Determination of the manganese uptake rate.
研究概览
简要总结
To quantify the manganese uptake rate after administration of mangafodipir trisodium in all segments of the left ventricular wall.
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Main Phase
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Participants who have given their signed declaration of consent and data protection declaration.
- •Males and females (postmenopausal or surgically sterile females) aged ≥ 18 years and ≤ 90 years
- •HFpEF (= LVEF > 50%) with NYHA (New York Heart Association) class I, II and III and objective evidence of cardial structural and/or functional abnormalitieconsistent with the presence of LV diastolic dysfunction/raised LV filling pressures, including raised natriuretic peptides.
- •Patients with HCM or CA (according to current guidelines).
- •Kidney functions eGFR (Estimated Glomerular Filtration Rate) > 30 mL/min/1.73 m2
- •Healthy volunteers (cohort specific criteria): adults with no known pre-existing medical condition.
排除标准
- •Tachycardia (heart rate >100, R-R interval <600ms)
- •Severe valvular disease.
- •Previous heart surgery.
- •Left ventricular assist device (LVAD).
- •Severe pulmonary disease.
- •Hypersensitivity to any medicinal products containing gadolinium.
- •Hypersensitivity to the active substance of the IMP or to any of the excipients.
- •Contraindications to MRI, including implanted cardiac devices / pacemakers.
- •Participants not able to follow instructions necessary to conduct the MRI.
- •Women of childbearing potential.
- •Participation in other clinical studies with investigational drugs either concurrently or within the last 30 days.
- •Previous participation in this clinical trial
- •History of ongoing drug abuse or alcoholism.
- •Legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope, and possible impact of the trial
- •Investigator site staff and sponsor directly involved in the conduct of the study and their family members.
- •Previous coronary artery disease requiring intervention, including history of myocardial infarction including septal reduction therapies.
- •Severely reduced renal function, defined as eGFR (Estimated Glomerular Filtration Rate) < 30mL/min/1.73 m
- •Severely reduced liver function (Child-Pugh class C), especially severe obstructive hepatobiliary disease.
- •Phaeochromocytoma
- •Advanced cancer (with short/medium term prognosis).
- •History of chest radiation therapy.
- •Diabetic patients
结局指标
主要结局
Primary endpoint: Determination of the manganese uptake rate.
Primary endpoint: Determination of the manganese uptake rate.
次要结局
- Safety: Frequency and severity of adverse events, injection site AEs, significant changes in vital signs, significant changes in ECG
- Efficacy: Difference in the uptake rate constant between healthy volunteers, HFpEF with HCM or CA.
研究者
Clinical trial coordinator
Scientific
IC Targets AS
研究点 (1)
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