[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658387":3},{"organization":4,"outcomesModule":7,"designInfo":56,"detailedDescription":60,"studyPopulation":61,"armGroups":62,"interventions":57,"overallOfficials":66,"centralContacts":71,"locations":80,"responsibleParty":101,"collaborators":57,"id":104,"slug":105,"hasResults":106,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":110,"eligibilityCriteria":111,"healthyVolunteers":106,"sex":112,"minAge":113,"maxAge":114,"enrollmentInfo":115,"targetDuration":57,"studyType":118,"phases":57,"briefSummary":119,"conditions":120,"keywords":123,"overallStatus":83,"whyStopped":57,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":138},{"fullName":5,"class":6},"Technical University of Munich","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":45},[9],{"measure":10,"description":11,"timeFrame":12},"Point prevalence of a reduced cardiac output to oxygen uptake slope at baseline.","Point prevalence of a reduced cardiac output to oxygen uptake slope (CO\u002FVO2 slope \\\u003C5) at baseline, as a marker of central (cardiac) limitation of exercise capacity.","Baseline, Visit 1 (V1), prior to chemotherapy initiation",[14,18,21,24,27,30,33,36,39,42],{"measure":15,"description":16,"timeFrame":17},"Cardiac output reserve during exercise","Difference between cardiac output at rest and peak exercise","Baseline (V1)",{"measure":19,"description":20,"timeFrame":17},"Heart rate reserve during exercise","Difference of heart rate between rest and peak exercise",{"measure":22,"description":23,"timeFrame":17},"Stroke volume reserve during exercise","Difference of stroke volume between peak exercise and rest",{"measure":25,"description":26,"timeFrame":17},"Minute ventilation to carbon dioxide production slope","Slope between minute ventilation and carbon dioxide production",{"measure":28,"description":29,"timeFrame":17},"Peak oxygen uptake","Peak oxygen uptake related to body weight and minute",{"measure":31,"description":32,"timeFrame":17},"Extent of late gadolinium enhancement on cardiac magnetic resonance imaging","Percentage of late gadolinium enhancement of the left ventricle on magnetic resonance imaging",{"measure":34,"description":35,"timeFrame":17},"Myocardial oedema on T2-mapping","Myocardial oedema on T2-mapping during magnetic resonance imaging at baseline",{"measure":37,"description":38,"timeFrame":17},"Native T1-time and extracellular volume on cardiac magnetic resonance imaging","Native T1-time and extracellular volume on cardiac magnetic resonance imaging at baseline",{"measure":40,"description":41,"timeFrame":17},"Correlation between cardiac output to oxygen uptake slope and native T1-time and extracellular volume on magnetic resonance imaging","Correlation between cardiac output to oxygen uptake slope and native T1-time and extracellular volume on magnetic resonance imaging at baseline",{"measure":43,"description":44,"timeFrame":17},"Incidence of malignant ventricular arrhythmias during combined cardiopulmonary exercise testing and stress echocardiography","Safety. Incidence of malignant ventricular arrhythmias (defined as sustained ventricular tachycardia, ventricular tachycardia with syncope, ventricular fibrillation, cardiopulmonary resuscitation) during combined cardiopulmonary exercise testing and stress echocardiography at baseline",[46,49,53],{"measure":47,"description":47,"timeFrame":48},"Association of baseline cardiac output to oxygen uptake with heart-failure hospitalisation, cardiovascular and all-cause mortality.","12 months (V3)",{"measure":50,"description":51,"timeFrame":52},"Change from baseline in cardiac biomarkers","Change of serum concentration in cardiac biomarkers (high-sensitivity troponin, NT-proBNP) from baseline (V1)","Baseline (V1) to 3 months (V2) and 12 months (V3)",{"measure":54,"description":55,"timeFrame":52},"Change in quality of life","Change from baseline (V1) in quality of life using the Kansas City Cardiomyopathy Questionnaire (KCCQ) score, 0 being the worst health condition and 100 being the best condition",{"allocation":57,"interventionModel":57,"interventionModelDescription":57,"primaryPurpose":57,"observationalModel":58,"timePerspective":59,"maskingInfo":57},null,"COHORT","PROSPECTIVE","Cardiovascular complications are increasingly recognised as a major determinant of morbidity and mortality in multiple myeloma, whether related to concomitant amyloidosis, direct cardiotoxicity of modern anti-myeloma therapies (including proteasome inhibitors such as carfilzomib and bortezomib), or pre-existing cardiovascular comorbidity unmasked by treatment. Patients whose resting echocardiogram is unremarkable or only mildly abnormal are not currently considered to have clinically manifest cardiac involvement. Whether such patients nonetheless already harbour an exercise-inducible cardiac limitation that cannot be detected at rest has not previously been investigated. A reduced cardiac output to oxygen consumption slope (CO\u002FVO2) has been proposed as a marker of central (cardiac), as opposed to peripheral (musculoskeletal), limitation of exercise capacity, but has never been evaluated in multiple myeloma. Guideline-based cardiotoxicity surveillance in oncology is built around resting-state pillars - cardiac biomarkers, resting echocardiography and, where indicated, cardiac magnetic resonance imaging (CMR) - none of which incorporates a functional, exercise-based assessment.\n\nAll clinical-functional baseline examinations (medical and sports history, laboratory testing, 12-lead electrocardiogram, ECG, resting echocardiography, 6-minute walk distance, and combined cardiopulmonary exercise testing with stress echocardiography, CPETecho) and CMR are performed. Resting echocardiography and CMR follow current European imaging guidelines. CPETecho is performed on a semi-supine bicycle ergometer with a ramp protocol aiming at 10-12 minutes of exercise duration to subjective (Borg scale \\>17) or metabolic (respiratory exchange ratio \\>1.05) exhaustion. Stress-echocardiographic variables are obtained at rest, at the first ventilatory threshold, and at peak exercise, and slopes (including CO\u002FVO2) are calculated by linear regression through these three time-points. All study procedures are performed as diagnostic add-ons to the clinical routine work-up. The study includes no therapeutic intervention and no control\u002Fcomparator group. Comparisons of interest (e.g. CO\u002FVO2 slope \\\u003C5 vs. ≥6, with values between 5 and 6 considered a physiological response to exercise) are made within the single study cohort.\n\nTwo protocol-defined, in-person clinical follow-up visits are performed for each patient, timed relative to that patient's own baseline visit (V1): V2 at 3 months and V3 at 12 months. Both comprise medical and sports history (including chart-documented ascertainment of morbidity, heart-failure hospitalisation and all-cause\u002Fcardiovascular mortality via hospital records), cardiac biomarkers, resting echocardiography, 6-minute walk distance, 12-lead ECG, and the Kansas City Cardiomyopathy Questionnaire (KCCQ) and Karnofsky index. CMR and CPETecho are performed only once, at baseline. For patients who cannot attend V2 or V3 in person, or who transfer care outside the university network, morbidity, hospitalisation and vital status are ascertained by chart-based review of hospital records and, where necessary, structured telephone contact. Adverse events, defined as malignant ventricular arrhythmias during exercise, are documented at every visit. CPETecho and CMR analyses are performed blinded by an experienced investigator; CMR readings are performed independently by two blinded specialists, with a third expert adjudicating discordance. Statistical analysis is descriptive and exploratory (no confirmatory hypothesis testing): the primary endpoint is reported as a proportion with a 95% Clopper-Pearson confidence interval; continuous secondary endpoints are summarised as means ± SD or medians (IQR); correlations between CO\u002FVO2 slope and CMR tissue parameters use Spearman rank correlation; group comparisons use the Mann-Whitney U test (continuous) or Fisher's exact test (categorical); the 12-month clinical outcome is described using Kaplan-Meier estimates. All analyses are hypothesis-generating (α=0.05, no correction for multiple testing).","Adult patients with newly diagnosed multiple myeloma who have not yet initiated chemotherapy, recruited via the haemato-oncology outpatient clinics.",[63],{"label":64,"type":57,"description":65,"interventionNames":57},"Newly diagnosed multiple myeloma, preserved left ventricular ejection fraction","Patients with newly diagnosed, histologically or cytologically confirmed multiple myeloma who have not yet started chemotherapy, and whose resting echocardiogram shows preserved left ventricular ejection fraction (≥50%) with at most mild (grade I) diastolic dysfunction and no echocardiographic signs of clinically manifest cardiac involvement. All participants undergo the identical non-interventional diagnostic protocol (baseline cardiopulmonary exercise testing and stress echocardiography, cardiac magnetic resonance imaging, structured clinical follow-up at 3 and 12 months); there is no comparator\u002Fcontrol group and no study intervention or treatment is assigned.",[67],{"name":68,"affiliation":69,"role":70},"Simon RDITU Wernhart, MD, PhD","TUM - Technische Universität München","PRINCIPAL_INVESTIGATOR",[72,77],{"name":73,"role":74,"phone":75,"phoneExt":57,"email":76},"Simon Wernhart, MD, PhD","CONTACT","491751830099","simon.wernhart@mri.tum.de",{"name":78,"role":74,"phone":57,"phoneExt":57,"email":79},"Sebastian Theurich, MD","Sebastian.Theurich@med.uni-muenchen.de",[81],{"facility":82,"status":83,"city":84,"state":85,"zip":86,"country":87,"countryCode":88,"cosmosGeoPoint":89,"geoPoint":94,"contacts":95},"Department of Preventive Sports Medicine and Sports Cardiology, TUM School of Medicine and Health, Klinikum rechts der Isar","RECRUITING","Munich","Bavaria","81675","Germany","DE",{"type":90,"coordinates":91},"Point",[92,93],11.57549,48.13743,{"lat":93,"lon":92},[96,97,98],{"name":73,"role":74,"phone":75,"phoneExt":57,"email":76},{"name":78,"role":74,"phone":57,"phoneExt":57,"email":79},{"name":99,"role":100,"phone":57,"phoneExt":57,"email":57},"Caterina Fiorentini, MD","SUB_INVESTIGATOR",{"type":70,"investigatorFullName":102,"investigatorTitle":103,"investigatorAffiliation":5,"oldNameTitle":57,"oldOrganization":57},"PD Dr. med. Dr. rer. nat. Simon Wernhart","Deputy of the Clinical Director","100658387","exercise-phenotyping-prior-to-chemotherapy-in-newly-diagnosed-multiple-myeloma-mm-exercise-100658387",false,"NCT07851493","Exercise Phenotyping Prior to Chemotherapy in Newly Diagnosed Multiple Myeloma (MM-Exercise)","Exercise Phenotyping Prior to Chemotherapy Initiation in Patients With Newly Diagnosed Multiple Myeloma Without Resting Echocardiographic Signs of Cardiac Involvement","MM-Exercise","Inclusion Criteria:\n\n* Histologically or cytologically confirmed newly diagnosed multiple myeloma and chemotherapy not yet initiated\n* Resting echocardiogram with preserved left ventricular ejection fraction (≥50%) and at most mild (grade I) diastolic dysfunction with no echocardiographic signs of clinically manifest cardiac involvement\n* Age 18-99 years\n* Written informed consent\n* Sufficient German or English language skills\n\nExclusion Criteria:\n\n* New York Heart Failure Association Class IV heart failure, or recent decompensated heart failure requiring inpatient recompensation\n* Suspected new or progressive coronary artery disease\n* Estimated glomerular filtration rate \\\u003C30 mL\u002Fmin\u002F1.73m², or contraindication to gadolinium-based contrast agents\n* Severe anaemia, defined as haemoglobin \\\u003C8 g\u002FdL at baseline\n* Pregnancy or breastfeeding","ALL","18 Years","99 Years",{"count":116,"type":117},80,"ESTIMATED","OBSERVATIONAL","MM-Exercise is a prospective, single-centre, observational pilot study of patients with newly diagnosed multiple myeloma who have not yet started chemotherapy and whose resting echocardiogram is unremarkable or only mildly abnormal (preserved left ventricular ejection fraction \\[LVEF\\] ≥50%, at most grade I diastolic dysfunction). The study tests whether a relevant proportion of these patients already exhibit a central (cardiac) limitation of exercise capacity - defined as a cardiac output to oxygen uptake slope (CO\u002FVO2 slope) below 5 - despite the absence of overt cardiac disease on resting assessment, and whether this exercise-derived marker correlates with subclinical myocardial tissue abnormalities on cardiac magnetic resonance imaging (CMR) and with heart-failure hospitalisation and mortality over 12 months. Eighty patients referred in comparable numbers from the haemato-oncology departments will undergo a single comprehensive baseline assessment (medical and sports history, cardiac biomarkers, resting echocardiography, 6-minute walk distance, combined cardiopulmonary exercise testing with stress echocardiography \\[CPETecho\\], and CMR with T1-\u002FT2-mapping and late gadolinium enhancement) prior to chemotherapy initiation, followed by in-person clinical follow-up visits 3 and 12 months after each patient's own baseline visit.",[121,122],"Exercise Behavior","Multiple Myeloma",[124,125,126,127,128],"cardiopulmonary exercise testing","cardio-oncology","stress echocardiography","exercise phenotyping","cardiac magnetic resonance imaging","2026-09-30",{"date":131,"type":132},"2026-10-05","ACTUAL",{"date":134,"type":132},"2026-09-01",{"date":136,"type":117},"2029-03",{"name":5,"class":6},1]