DRKS00015615招募中不适用
Study to analyze parameters of internal and external cardiac power, cardiac output and aortic compliance using cardiac magnet resonance imaging in patients with heart failure - EMPATHY-HF
Charité Campus Virchowklinikum Medizinische Klinik mit Schwerpunkt Kardiologie0 个研究点目标入组 90 人开始时间: 2018年10月22日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 90
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 45 Years 至 one（—）
- 性别
- All
入选标准
- •must provide written informed consent
- •Age >45 years
- •Signs and symptoms of heart failure NYHA II-IV (at least 30 days prior to screening)
- •in clinically stable condition defined as no i.v. therapy with diuretics or inotropics and no hospitalization within the last 7 days
- •unchanged medication at least 7 days prir to screening
- •must have health insurance (to cover treatment costs arising from incidental findings on MRI)
- •Sub-group HFpEF:
- •HFpEF (according to Paulus et al.) - Baseline-Echocardiography with the following findings:
- •Ejection Fraction (EF) =50 und
- •NT-proBNP = 220 pg/ml while in sinus rhythm at screening
- •LAVI (left atrialer volume index) > 34 ml/m2
- •E/e´ > 13 (medial or lateral mitral anulus)
- •LV-Hypertophy: septal wall thickness or posterior wall thickness = 13mm
- •Sub-group HFrEF:
- •EF <40% in echocardiography during screening
- •individualized optimized and unchanged (at least 7 days prior to screening ) heart failure therapy (must include Beta-Blocker, ACE-Inhibitor/ AT1-Inhibitor, Aldosteron-Antagonist as long as no contraindicationst)
- •EF <40% in imaging within 90 days of screening.
- •Sub-group HFmrEF
- •EF 40-49%
- •NT-proBNP = 220 pg/ml while in Sinus rhythm on screening
- •LAVI (left atrialer volume index) > 34 ml/m2
- •E/e´ > 13 (medial or lateral mitral anulus)
- •LV-Hypertophy: septal wall thickness or posterior wall thickness = 13mm
- •Sub-group healthy controls:
- •No clinically relevant structural heart disease
- •No symptoms of heart failure
- •No symptoms of CAD
- •No relevant arrhythmia
- •No valve defects >I°
- •LVEF = 55%
- •must provide written informed consent
- •Age >45 years
- •must have health insurance (to cover treatment costs arising from incidental findings on MRI)
排除标准
- •Contractual incapacity
- •Atrial Fibrillation
- •symptomatic CAD with Angina pectoris > CCS II
- •recent PCI within 4 weeks or planned PCI/CABG-surgeryI
- •myocardial infarction within the last 3 months
- •stroke within the last 3 months
- •Relevantes valve defect > II°
- •hypertrophic obstructive or infiltrative cardiac disease (z.B.: HOCM, Amyloidose)
- •complex congenital heart defect
- •ongoing myokarditis
- •significant pulmonary disease in investigators discreation
- •significant arrhythmia in investigators discretion
- •persistent atrial fibrillation
- •planned changes of concomitant medication
- •planed heart transplantation, status post heart transplantation
- •Cardiac Resynchronisation Therapy (CRT) begun within last 3 months
- •ICD/Pacemaker implanted within last 4 weeks
- •Uncontrolled Hyper-/Hypotension (sysBP > 180 mmHg/ diasBP > 95mmHg)
- •Enrolled in rehabilitation program
- •known malignant disease limiting life expectancy <1 year
- •Anemia, Hb < 10 mg/dl
- •Pregnant or breastfeeding women
- •untreated clinically significant disease of the thyroid
- •Additional MRI-contraindications
- •-history of claustrophobia
- •-history of hardness of hearing >30 dB
- •-history of tinnitus
- •-implanted pump-devices
- •-recently implanted joint prothesis
- •-metal coils within the brain
- •-Neurostimulators
- •-Cochlea-Implantation
- •-other, older ear implants
- •-magnetically attached teeth prothesis
- •-Metalsplinters from shells within the body
- •-history of neurosurgery using metal clips
- •-early pregnancy <3 months
- •Patients with contrast medium allergy or impaired renal function (GFR<40ml/min/1,73m²KO)
- •unstable cardiorespiratory state within last 4 weeks
- •i.v. administration of diuretics or inotropics within 7 days prior to screening
- •myocardial infarction within 4 days prior to inclusion
研究者
相似试验
尚未招募
不适用
Analyses of extrinsic and intrinsic factors which regulate the immune modulation in polytraumaS28T89T81T88T79T93T94T90I97R57I50D65V99Crushing injury of thorax and traumatic amputation of part of thoraxComplications of procedures, not elsewhere classifiedOther complications of surgical and medical care, not elsewhere classifiedCertain early complications of trauma, not elsewhere classifiedSequelae of injuries of lower limbSequelae of injuries involving multiple and unspecified body regionsSequelae of injuries of headPostprocedural disorders of circulatory system, not elsewhere classifiedShock, not elsewhere classifiedDisseminated intravascular coagulation [defibrination syndrome]Unspecified transport accidentHeart failureDRKS00017215Klinik für Unfall-, Hand- und Wiederherstellungschirurgie, Universitätsklinikum Frankfurt, Goethe Universität550
终止
不适用
Exploring the impact of internal versus external attentional targets on mindfulness skills acquisition in individuals with history of depression or anxietyMindfulness skills (sustained attention, switching attention, nonelaborative processing)ResilienceStressEmotional regulation skillsGeneral psychological wellbeingAlternative and Complementary Medicine - Other alternative and complementary medicineMental Health - DepressionMental Health - AnxietyDepressionAnxietyACTRN12616001085460Murdoch University60
尚未招募
不适用
Comparative evaluation of effect of application of external maneuvers with no maneuver on glottis view during videolaryngoscopy in patients undergoing elective surgery with head in neutral position.CTRI/2022/12/048313Safdarjung Hospital and Vardhman Mahavir Medical College
已完成
不适用
Study of relationship of internal derang ement of TMJ, maxillofacial morpholog y and stomatognathic functiomalocclusionJPRN-UMIN000026333Division of Orthodontics and Dentofacial Orthopedics, Tohoku University Graduate School of Dentistry110
已完成
不适用
A study to compare different intravenous fluids on certain blood parameters during the surgery in patients undergoing elective surgery for brain tumorsCTRI/2022/02/039979Dr Abinaya Prakashbabu75