[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"transthyretin-amyloid-cardiomyopathy-attr-cm\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:transthyretin-amyloid-cardiomyopathy-attr-cm":149},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,41,72,97,123],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100608919","phase-3-cleopattra-a-research-study-to-look-at-the-effects-of-treatment-with-a-medicine-called-coramitug-nnc6019-0001-in-people-with-heart-failure-due-to-transthyretin-amyloid-attr-amyloidosis-100608919",false,"NCT07207811","CLEOPATTRA: A Research Study to Look at the Effects of Treatment With a Medicine Called Coramitug (NNC6019-0001) in People With Heart Failure Due to Transthyretin Amyloid (ATTR) Amyloidosis","CLEOPATTRA: Effects of NNC6019-0001 Versus Placebo on Cardiovascular Outcomes in Participants With Transthyretin Amyloid Cardiomyopathy (ATTR-CM)","CLEOPATTRA","Inclusion Criteria:\n\n* Male or female.\n* Age 18 years or above at the time of signing the informed consent.\n* Have an established diagnosis of ATTR-CM (wild-type ATTR \\[ATTRwt\\] or variant ATTR \\[ATTRv\\]), with cardiac amyloid infiltration, increased left ventricular (LV) wall thickness, and HF.\n\nNote: Target ATTRv recruitment is approximately 15 percent of the study population.\n\na. Cardiac amyloid infiltration demonstrated by: i. Cardiac biopsy positive for TTR amyloid, OR ii. Grade 2 or 3 cardiac uptake at pyrophosphate (PYP)\u002Fdiphosphono-1,2-propanodicarboxylic acid (DPD)\u002F hydroxymethylene diphosphonate (HMDP) nuclear medicine imaging with single-photon emission computed tomography (SPECT) or SPECT\u002FCT (preferably) combined with an extracardiac biopsy positive for TTR amyloid, OR iii. Grade 2 or 3 cardiac uptake at PYP\u002FDPD\u002FHMDP nuclear medicine imaging with SPECT or SPECT\u002FCT (preferably) combined with normal serum free light chain ratio, and negative serum and urine protein electrophoresis with immunofixation (SPIE \\& UPIE)\u002For mass spectrometry based methods including mass fixation).\n\nNotes:\n\n* Non-invasive diagnostic pathway will be confirmed by a centralised expert review.\n* Bone tracer nuclear medicine imaging with SPECT or SPECT\u002FCT (preferably) will be conducted using 99m-technetium (Tc)-labelled pyrophosphate (99mTc-PYP), 99mTc-labelled 3,3-diphosphono-1,2-propanodicarboxylic acid (99mTc-DPD), or 99mTc-labeled hydroxymethylene diphosphonate (99mTc-HMDP).\n* The eGFR adjusted acceptable serum free light chain ratio.\n* Patients with Grade 2 or 3 cardiac uptake at PYP\u002FDPD\u002FHDMP nuclear imaging with SPECT or SPECT\u002FCT (preferably) and evidence of monoclonal gammopathy of undetermined significance (MGUS; based on serum and urine protein electrophoresis and serum free light chains) will require endomyocardial biopsy with typing using mass spectrometry or immunohistochemistry to confirm presence of TTR protein in tissue.\n* Timing of serum free light chain ratio, SPIE, UPIE and mass spectrometry-based methods including mass fixation should be within 12 months of SPECT or SPECT\u002FCT nuclear imaging.\n\n  b. Increased LV wall thickness, as assessed by centralised review of echocardiography, showing interventricular septal wall thickness greater than or equal to 12 millimeter (mm).\n\n  c. Chronic HF (New York Heart Association \\[NYHA\\] Class I-IV): i. At least 1 documented hospitalisation for HF, OR ii. History of HF manifested by signs or symptoms of volume overload or elevated intracardiac pressures (e.g., elevated jugular venous pressure, shortness of breath, signs of pulmonary congestion on x-ray or auscultation, or peripheral oedema that required or requires ongoing treatment with a diuretic).\n  * Expected to be on stable cardiovascular medical therapy (defined as no greater than 50 percent dose adjustment and no categorical changes of medications), with the exception of diuretics, 4 weeks prior to the randomisation visit.\n  * Completed more than 50 meters on the 6MWT at screening.\n\nExclusion Criteria:\n\n* Known or suspected hypersensitivity to study intervention(s) or related products.\n* Current or previous participation (dosing with active treatment) in a study for an investigational ATTR depleting drug or ATTR gene editing therapy.\n* Total bilirubin greater than 3 times the upper limit of normal (ULN) at screening.\n* Current diagnosis or history of amyloid light chain, other non-ATTR amyloidosis, known leptomeningeal amyloidosis, or multiple myeloma.\n* HF not primarily caused by ATTR-CM (e.g., due to hypertension, valvular heart disease, or ischemic heart disease in the opinion of the investigator).\n* Currently hospitalised or hospitalised within 14 days prior to screening.\n* Currently treated with positive inotropic medication.\n* Uncorrected, severe, haemodynamically significant, left-sided heart valve disease.\n* Acute coronary syndrome, unstable angina, stroke, transient ischemic attack, coronary revascularisation, cardiac device implantation, cardiac valve repair, or major surgery within 60 days of screening.\n* Prior solid organ transplant or planned solid organ transplant during the study.\n* Left ventricular ejection fraction (LVEF) less than 30 percent as assessed by centralised review of echocardiography.\n* Presence or history of malignant neoplasm (other than basal or squamous cell skin cancer, in situ carcinomas of the cervix, carcinoma in situ\u002Fhigh-grade prostatic intraepithelial neoplasia \\[PIN\\], low-risk prostate cancer, or on stable therapy for prostate cancer) within 3 years before screening.\n* End-stage renal disease (estimated glomerular filtration rate \\[eGFR\\] less than 15 mL\u002Fmin\u002F1.73 m\\^2 at screening, or chronic\u002Fintermittent haemodialysis or peritoneal dialysis).","ALL","18 Years",{"count":20,"type":21},1280,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","This study will find out if a new medicine called NNC6019-0001 can help reduce the risk of heart-related death and illness in participants with a condition called transthyretin amyloid cardiomyopathy (ATTR-CM), which affects the heart. Participants will either receive NNC6019-0001 or a placebo (a treatment with no active medicine), and which one they get is decided by chance. Everyone in the study will continue receiving their usual heart treatments as recommended by their doctor.",[27],"Transthyretin Amyloid Cardiomyopathy (ATTR CM)","RECRUITING","2026-06-24",{"date":31,"type":32},"2026-06-25","ACTUAL",{"date":34,"type":32},"2025-10-02",{"date":36,"type":21},"2029-06-29",{"name":38,"class":39},"Novo Nordisk A\u002FS","INDUSTRY",290,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":54,"conditions":55,"keywords":57,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":71},"100641574","phase-2-a-study-to-evaluate-the-efficacy-and-safety-of-concomitant-use-of-eplontersen-and-alxn2220-compared-with-eplontersen-and-placebo-for-adults-participants-with-attr-cm-100641574","NCT07608354","A Study to Evaluate the Efficacy and Safety of Concomitant Use of Eplontersen and ALXN2220 Compared With Eplontersen and Placebo for Adults Participants With ATTR-CM","A Phase IIb, Randomised, Double-blind, Placebo-controlled, Multicentre Study to Evaluate the Efficacy and Safety of Concomitant Use of Eplontersen and ALXN2220 Compared With Eplontersen and Placebo in Adult Participants With Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR-CM)","ATTRiumph","Capable of giving informed consent.\n\nInclusion Criteria:\n\n* Participant must be ≥ 18 years to ≤ 85 years at the time of signing the informed consent.\n* Participants who have a diagnosis of ATTR-CM with either wild-type or variant TTR genotype based on 1 of the following:\n\n  1. Endomyocardial biopsy with confirmatory TTR amyloid typing OR\n  2. Grade 2 or 3 cardiac uptake on 99mTc scintigraphy in the absence of monoclonal gammopathy OR\n  3. Grade 2 or 3 cardiac uptake on 99mTc scintigraphy AND confirmatory TTR amyloid typing in the presence of monoclonal gammopathy.\n* NYHA Class I to III at Screening and life expectancy of ≥ 1 year as per the Investigator's judgement.\n* End-diastolic IVST ≥ 12 mm on echocardiography.\n* NT-proBNP ≥ 600pg\u002FmL for participants without ongoing atrial fibrillation\u002Fflutter at Screening or NT-proBNP ≥ 1200pg\u002FmL for participants with ongoing atrial fibrillation\u002Fflutter at Screening.\n* Able to complete symptom-limited maximal CPET at Screening based on the following test criteria:\n\n  1. Able to exercise to near exhaustion during CPET as exhibited by RER ≥ 1.0 during symptom-limited CPET conducted during screening.\n  2. If participant does not achieve RER ≥1.0, the CPET may be repeated once, at least 48 hours but less than 2 weeks (but before randomization) after the initial test.\n* Treated according to locally recognised guidelines on standard-of-care treatment for patients with HF. Therapy should have been individually optimised and stable for ≥ 4 weeks (except diuretics) and include, unless contraindicated or not tolerated, treatment of high BP (targeting SBP \\\u003C 130 mmHg as suggested in 2022 American College of Cardiology\u002FAmerican Heart Association\u002FHeart Failure Society of America HF guidelines), and ischaemic heart disease.\n* Willingness to adhere to daily self-administered vitamin A supplementation (3000 IU).\n\nExclusion Criteria:\n\n* Known leptomeningeal amyloidosis.\n* Known light chain (AL) or secondary (amyloid A) amyloidosis, or any other form of systemic amyloidosis.\n* Cardiomyopathy not primarily caused by ATTR-CM, for example, cardiomyopathy primarily due to hypertension, valvular heart disease, or ischaemic heart disease per Investigator's assessment.\n* Acute coronary syndrome, unstable angina, stroke, transient ischaemic attack, coronary revascularisation, cardiac device implantation, cardiac valve repair, or major surgery within 12 weeks of Screening.\n* Uncontrolled hypertension (average resting SBP \\> 160 mmHg or DBP \\> 100 mmHg at Screening).\n* Average resting SBP \\\u003C 90 mmHg or symptomatic orthostatic hypotension, despite appropriate treatment, at Screening per Investigator's assessment.\n* Uncontrolled ventricular clinically significant cardiac arrhythmia, per Investigator's assessment.\n* Left ventricular ejection fraction \\\u003C 30% on echocardiography measured locally at Screening.\n* Severe pulmonary impairment (SpO₂ \\\u003C 92%) defined as resting SpO₂ below 92% on room air, measured by pulse oximetry, indicative of severe lung disease. Participants requiring supplemental oxygen to maintain SpO₂ ≥ 92%.\n* Participants with renal failure requiring dialysis.\n* History of solid organ transplantation or ventricular assist device or listing for heart transplantation at Screening. Note: prior history of planned corneal transplant is not an exclusion criterion.\n* Suspected or known intolerance\u002Fallergy to proteins or any components of the study intervention.\n* Any of the following results conducted at screening:\n\n  i) Haemoglobin \\\u003C8g\u002FdL for women or \\\u003C9g\u002FdL for men. ii) Platelet count \\\u003C125 X10\\*9\u002FL or other disorder associated with clinically significant thrombocytopenia.\n\niii) ALT \\>2.0 X ULN iv) TBL \\>2.5 X ULN (participants with known Gilbert's syndrome can be included with TBL \\>2.5 X ULN as long as direct bilirubin is ≤ 1.5 X ULN) v) Serum retinol level \\\u003C LLN vi) By CKD-EPI formula, eGFR \\\u003C20 mL\u002Fmin\u002F1.73 m2 measured by the central laboratory at Screening.\n\n* Current unstable liver or biliary disease per Investigator's assessment.\n* Multiple myeloma, lymphoma, leukemia, or any malignancy or clonal stem cell disorder within the past 5 years (except basal cell or squamous epithelial carcinomas of the skin, melanoma in situ or cervical carcinoma in situ that have been curatively resected, Stage I cancer in remission, or adequately treated prostate cancer stage I, IIA, or IIB with Gleason score ≤ 3+4 and prostate-specific antigen \\\u003C 20 ng\u002FmL).\n* Any prior treatment with an ATTR amyloid depleter or a TTR gene silencing agent approved or in clinical development.\n* Participated in a structured exercise training programme within the 1 month prior to Screening or planned to start during the trial.\n* Participation in another investigational clinical study or intake of another investigational drug within 30 calendar days or 5 half-lives of the IMP, whichever is longer before signing the ICF.\n* Judgement by the Investigator that the participant should not participate in the study if the participant has a known medical or psychological condition or other risk factor that might interfere with the participant's full participation in the study, pose any additional risk for the participant, or confound the assessment of the participant or outcome of the study.\n* Previous enrolment or randomisation in the present study.","85 Years",{"count":51,"type":21},326,[53],"PHASE2","The purpose of this randomised, double-blind, placebo-controlled, multicenter study is to evaluate the efficacy and safety of concomitant use of eplontersen and ALXN2220 compared with eplontersen and placebo in adult participants with Transthyretin-mediated amyloid cardiomyopathy (ATTR-CM).",[56],"Transthyretin Amyloid Cardiomyopathy (ATTR-CM)",[58,59,60,61],"Transthyretin amyloid cardiomyopathy","ATTR-CM","Eplontersen","ALXN2220","2026-06-16",{"date":64,"type":32},"2026-06-17",{"date":66,"type":32},"2026-06-11",{"date":68,"type":21},"2029-02-06",{"name":70,"class":39},"AstraZeneca",78,{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":82,"phases":4,"briefSummary":83,"conditions":84,"keywords":85,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":96},"100635781","single-arm-multi-center-study-evaluating-the-acceptance-and-feasibility-of-a-digital-remote-monitoring-tool-configured-for-patients-with-attr-cm-aco-monitor-100635781","NCT07557147","Single-arm, Multi-center Study Evaluating the Acceptance and Feasibility of a Digital Remote Monitoring Tool Configured for Patients With ATTR-CM: ACO-Monitor","An Observational Study to Learn More About How Acceptable and Practical a Digital Remote Monitoring Tool (Luscii) is in People With Transthyretin Amyloid Cardiomyopathy (ATTR-CM)","ACO-MONITOR","Inclusion Criteria:\n\n* Adult (≥18 years at the date of signing the informed consent form (ICF)).\n* Diagnosis of either wild-type or variant ATTR-CM.\n* Treatment with a drug approved for ATTR-CM, including newly prescribed therapy at the initial visit.\n* Signed ICF.\n* Access to and basic ability to use a personal smartphone with internet connectivity sufficient to install and operate the Luscii contact application.\n\nExclusion Criteria:\n\n* Participation in an investigational program with interventions outside of routine clinical practice.\n* Patients who are unable to provide consent, including those whose consent would need to be given by a legal representative.",{"count":81,"type":21},60,"OBSERVATIONAL","Transthyretin amyloid cardiomyopathy (ATTR-CM) is a heart condition caused by a protein called transthyretin (TTR) building up as amyloid in the heart muscle. This build-up makes the heart stiff and can lead to symptoms of heart failure, such as difficulty breathing, tiredness, swelling in the legs, and reduced ability to be physically active. ATTR-CM occurs in two forms: a hereditary (variant) type caused by changes in genes, and a wild-type form that usually develops with aging.\n\nPeople living with ATTR-CM are usually cared for at specialist centers, which may require them to travel long distances for appointments. Because of this, visits may be infrequent, and sometimes people only see their doctor once a year. This can make it harder to notice if the disease is getting worse or if there are problems with following their treatment plan. As a result, important changes in health may go unnoticed for several months, which can be risky.\n\nRemote monitoring offers a way for people living with ATTR-CM and their healthcare professionals to stay connected between clinic visits. Recent studies have shown that remote monitoring can help by making it easier to share health information, spot problems earlier, and support people to follow their treatment plans. This can lead to fewer hospital visits and better health outcomes.\n\nLuscii is a digital remote monitoring tool designed to help people living with ATTR-CM and their healthcare professionals stay connected between clinic visits. Luscii has two main parts: Luscii contact, a smartphone app that allows secure messaging and video calls, and Luscii vitals, a clinical software system that organizes health data and can alert the healthcare team if there are changes that need attention. Luscii vitals is a CE-marked medical device used within its approved purpose and does not replace a doctor's judgement.\n\nBy making it easier to communicate and share information, Luscii aims to support earlier detection of problems, better management of ATTR-CM, and a more positive experience for people living with this condition.\n\nThe main purpose of this observational study, called ACO-MONITOR, is to learn how acceptable and practical Luscii is for people living with ATTR-CM and their healthcare professionals. The study will take place in Austria, Germany, and Italy at three specialist centers. About 60 adults with a diagnosis of hereditary or wild-type ATTR-CM will be invited to take part. There will be no treatments given as part of this study. Instead, participants will use the Luscii app and devices at home to track their health and share information with their healthcare professionals. The study team will provide training on how to use Luscii and will help participants get started.\n\nThe study team will look at:\n\n* How quickly and how often participants and healthcare professionals use Luscii\n* How long Luscii is used by each person\n* How many times participants use Luscii after being reminded\n* How easy Luscii is to use, based on questionnaires for both participants and healthcare professionals\n\nThe study will last about 18 months in total, including a 6-month period to invite participants and a 12-month follow-up period. During the study, the study team will:\n\n* Support participants in using Luscii to share health information from home\n* Monitor how often and how easily Luscii is used\n* Ask participants and healthcare professionals about their experiences using Luscii, including what worked well and what could be improved\n* Record any problems or technical issues with using Luscii By collecting this information, the researchers hope to learn if Luscii can help improve communication, support earlier detection of health problems, and make it easier for people living with ATTR-CM to manage their condition between clinic visits.",[56],[86],"Remote monitoring, Digital health, ATTR-CM","NOT_YET_RECRUITING","2026-06-10",{"date":66,"type":32},{"date":91,"type":21},"2026-08-31",{"date":93,"type":21},"2028-03-28",{"name":95,"class":39},"Bayer",3,{"id":98,"slug":99,"hasResults":11,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":103,"eligibilityCriteria":104,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":105,"targetDuration":4,"studyType":82,"phases":4,"briefSummary":107,"conditions":108,"keywords":109,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":122},"100611044","a-study-to-learn-about-the-use-of-acoramidis-in-patients-with-a-heart-condition-called-transthyretin-amyloid-cardiomyopathy-attr-cm-in-a-real-world-setting-100611044","NCT07235462","A Study to Learn About the Use of Acoramidis in Patients With a Heart Condition Called Transthyretin Amyloid Cardiomyopathy (ATTR-CM) in a Real-world Setting","ACO-REAL - A Non-interventional Study Providing Insights Into the Use of Acoramidis in Patients With ATTR Amyloidosis With Cardiomyopathy (ATTR-CM) in Routine Clinical Practice","ACO-REAL","Inclusion Criteria:\n\n* \\- Adults (≥18 years at the date of signing the informed consent form (ICF)).\n* Diagnosis of either wild-type or variant ATTR-CM.\n* Signed ICF.\n* Decision to initiate treatment with acoramidis was made as per treating investigator's routine treatment practice before signature of ICF.\n* Treatment start with acoramidis within 90 days after signing the ICF, with the possibility of starting acoramidis on the same day as signing the ICF.\n\nExclusion Criteria:\n\n* Participation in an investigational trial with interventions outside of routine clinical practice, except for participation in potential sub-studies related to this observational study. Please note: In addition to this observational study, separate sub-studies may be conducted to collect additional data. Participation in these sub-studies is voluntary and will be governed by separate protocols and informed consent processes. The main observational study does not include interventional procedures beyond routine clinical practice.\n\n  * Contra-indications according to the local SmPC of acoramidis.\n  * Patients who are unable to provide consent, including those whose consent would need to be given by a legal representative.",{"count":106,"type":21},2000,"Transthyretin Amyloid Cardiomyopathy (ATTR-CM) is a serious and life-threatening condition where a protein called transthyretin (TTR) misfolds and builds up as amyloid fibrils in the heart muscle. This buildup causes the heart to become stiff, leading to restrictive cardiomyopathy and progressive heart failure. There are two forms of ATTR-CM: a hereditary or 'variant' form (vATTR-CM) caused by a gene mutation, and a 'wild-type' form (wtATTR-CM) which is associated with aging. Because its symptoms can be similar to other heart conditions, ATTR-CM is often diagnosed late. However, recent advances in medical imaging are helping doctors to identify the disease earlier. Acoramidis is a new medication designed to treat ATTR-CM. It works by stabilizing the TTR protein, preventing it from misfolding and forming the harmful amyloid deposits. Acoramidis has been shown to be effective and safe in a major clinical trial (the ATTRibute-CM study), which led to its approval for use in both the United States and Europe. While clinical trials provide valuable information, data on how a new medicine performs in everyday clinical practice is also very important. This type of information is called real-world evidence. Currently, there is limited real-world information about the use of acoramidis. This study, called ACO-REAL, is an observational study, which means researchers will observe patients who are receiving acoramidis as part of their normal clinical care, without introducing any experimental interventions. The study will take place in approximately 20 European countries and aims to enroll up to 2,000 adults who have been diagnosed with either wild-type or variant ATTR-CM and are starting treatment with acoramidis. This includes patients who have not been treated for ATTR-CM before, as well as those who have been treated with other therapies. The main goals of the study are to understand the characteristics of patients being treated with acoramidis and to document how the treatment is used in routine medical practice. The study will also collect information on the safety of acoramidis. Furthermore, researchers will assess how the treatment affects patients' heart function, their functional capacity (such as their ability to walk), their overall health status, and their quality of life. The study will also track how often patients need to use healthcare resources like hospitals or emergency rooms. This information will help to improve the understanding and management of ATTR-CM in a real-world setting, ultimately aiming to optimize care for patients with this progressive disease.",[56],[110,111,112,113],"Transthyretin Amyloidosis","Cardiomyopathy","Heart Failure","Wild-type Amyloidosis","2026-03-30",{"date":116,"type":32},"2026-03-31",{"date":118,"type":32},"2025-10-29",{"date":120,"type":21},"2028-07-03",{"name":95,"class":39},1,{"id":124,"slug":125,"hasResults":11,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":4,"eligibilityCriteria":129,"healthyVolunteers":130,"sex":17,"minAge":18,"maxAge":131,"enrollmentInfo":132,"targetDuration":4,"studyType":82,"phases":4,"briefSummary":134,"conditions":135,"keywords":136,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":148},"100542117","thailand-attr-cm-registry-100542117","NCT06338696","Thailand ATTR-CM Registry","Thailand Transthyretin Amyloid Cardiomyopathy Registry","Inclusion Criteria:\n\n* Age \\> 18 years.\n* All patients diagnosed with ATTR-CM (Transthyretin cardiomyopathy) who have either symptomatic or asymptomatic must have evidence of cardiac involvement by echocardiogram as defined by left ventricle wall thickness of ≥ 12 mm and with at least one of the following criteria:\n* Positive scintigraphy by 99mTC-DPD \\[99mTC-3,3-diphosphono-1,2-propano-dicarboxylic acid\\] or 99mTC-PYP \\[Pyrophosphate\\] or 99mTC-HMDP \\[hydroxymethylene diphosphate\\] with Perugini grade ≥ 2 and\u002For H\u002FCL (heart to contralateral lung) ratio \\> 1.5\n* Positive scintigraphy by 99mTC-DPD \\[99mTC-3,3-diphosphono-1,2-propano-dicarboxylic acid\\] or 99mTC-PYP \\[Pyrophosphate\\] or 99mTC-HMDP \\[hydroxymethylene diphosphate\\] with Perugini grade 1 and positive cardiac biopsy tissue confirmed which Congo red stain ≥ 4 sites\n* Positive scintigraphy by 99mTC-DPD \\[99mTC-3,3-diphosphono-1,2-propano-dicarboxylic acid\\] or 99mTC-PYP \\[Pyrophosphate\\] or 99mTC-HMDP \\[hydroxymethylene diphosphate\\] with Perugini grade 1 with positive non-cardiac biopsy tissue confirmed by Congo red stain\n* Abnormalities on CMR (Cardiac MRI) \\[Subendocardium LGE (late gadolinium enhancement) and\u002For elevated native T1 value and\u002For increased extracellular volume (ECV \\> 0.4)\\] with positive non-cardiac and\u002For cardiac tissue biopsy confirmed by Congo red stain\n\nExclusion Criteria:\n\n* Diagnosed with amyloidosis caused by proteins other than transthyretin (light chain Amyloidosis, etc.)\n* Diagnosed with secondary amyloidosis",true,"100 Years",{"count":133,"type":21},105,"The investigators of this registry aim to study the natural history, clinical presentation, characteristics, and imaging findings of patients diagnosed with ATTR amyloidosis in Thailand longitudinally. This will enable the investigators to study this disease in depth. With a better understanding, the investigators can aim to develop early screening programs for at-risk patients, raising awareness among non-cardiologists. As amyloid-specific therapies have now become available in Thailand, the findings of this registry can be helpful for epidemiological studies in Thailand.",[56],[137,112,111],"Transthyretin amyloid cardiomyopathy (ATTR-CM)","2025-05-05",{"date":140,"type":32},"2025-05-08",{"date":142,"type":32},"2024-07-30",{"date":144,"type":21},"2030-06-30",{"name":146,"class":147},"Mahidol University","OTHER",8,"Transthyretin Amyloid Cardiomyopathy (\"ATTR-CM\")"]