The Effects of Sirolimus in Patients With Dilated Cardiomyopathy Infected With Kaposi Sarcoma-associated Virus

Launched by TONGJI HOSPITAL · Jan 24, 2024

Nctid: NCT06236022

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{"id"=>"M7442", "name"=>"DNA Virus Infections", "relevance"=>"LOW"}, {"id"=>"M12328", "name"=>"Neoplasms, Vascular Tissue", "relevance"=>"LOW"}, {"id"=>"M9420", "name"=>"Cardiomegaly", "relevance"=>"LOW"}, {"id"=>"M2392", "name"=>"Laminopathies", "relevance"=>"LOW"}, {"id"=>"M23686", "name"=>"Genetic Diseases, Inborn", "relevance"=>"LOW"}, {"id"=>"T5284", "name"=>"Soft Tissue Sarcoma", "asFound"=>"Sarcoma", "relevance"=>"HIGH"}, {"id"=>"T1876", "name"=>"Dilated Cardiomyopathy", "asFound"=>"Dilated Cardiomyopathy", "relevance"=>"HIGH"}, {"id"=>"T3199", "name"=>"Kaposi Sarcoma", "asFound"=>"Kaposi's Sarcoma", "relevance"=>"HIGH"}], "browseBranches"=>[{"name"=>"Infections", "abbrev"=>"BC01"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"Heart and Blood Diseases", "abbrev"=>"BC14"}, {"name"=>"Diseases and Abnormalities at or Before Birth", "abbrev"=>"BC16"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D000020123", "term"=>"Sirolimus"}], "ancestors"=>[{"id"=>"D000000900", "term"=>"Anti-Bacterial Agents"}, {"id"=>"D000000890", "term"=>"Anti-Infective Agents"}, {"id"=>"D000000903", "term"=>"Antibiotics, Antineoplastic"}, {"id"=>"D000000970", "term"=>"Antineoplastic Agents"}, {"id"=>"D000000935", "term"=>"Antifungal Agents"}, {"id"=>"D000007166", "term"=>"Immunosuppressive Agents"}, {"id"=>"D000007155", "term"=>"Immunologic Factors"}, {"id"=>"D000045505", "term"=>"Physiological Effects of Drugs"}], "browseLeaves"=>[{"id"=>"M21960", "name"=>"Sirolimus", "asFound"=>"Vitamin D", "relevance"=>"HIGH"}, {"id"=>"M4222", "name"=>"Anti-Bacterial Agents", "relevance"=>"LOW"}, {"id"=>"M4214", "name"=>"Anti-Infective Agents", "relevance"=>"LOW"}, {"id"=>"M4224", "name"=>"Antibiotics, Antitubercular", "relevance"=>"LOW"}, {"id"=>"M6252", "name"=>"Clotrimazole", "relevance"=>"LOW"}, {"id"=>"M11796", "name"=>"Miconazole", "relevance"=>"LOW"}, {"id"=>"M4254", "name"=>"Antifungal Agents", "relevance"=>"LOW"}, {"id"=>"M10212", "name"=>"Immunosuppressive Agents", "relevance"=>"LOW"}, {"id"=>"M10201", "name"=>"Immunologic Factors", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Anti-Infective Agents", "abbrev"=>"Infe"}, {"name"=>"Antineoplastic Agents", "abbrev"=>"ANeo"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE4"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>276}}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2024-01-01", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2028-12-31", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-01-24", "studyFirstSubmitDate"=>"2024-01-24", "studyFirstSubmitQcDate"=>"2024-01-24", "lastUpdatePostDateStruct"=>{"date"=>"2024-02-01", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-02-01", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2028-12-31", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Cardiac mortality", "timeFrame"=>"up to 36 months", "description"=>"Death from cardiovascular disease which includes coronary artery diseases, stroke, heart failure, hypertensive heart disease, rheumatic heart disease, cardiomyopathy, heart arrhythmia, congenital heart disease, valvular heart disease and carditis"}, {"measure"=>"Rate of heart transplantation", "timeFrame"=>"up to 36 months", "description"=>"The rate of heart trans plantation on patients with DCM when other medical or surgical treatments have failed"}], "secondaryOutcomes"=>[{"measure"=>"Readmission rate for cardiovascular diseases", "timeFrame"=>"up to 36 months", "description"=>"The readmission rate for cardiovascular diseases"}, {"measure"=>"Recurrence rate of heart failure", "timeFrame"=>"up to 36 months", "description"=>"The recurrence rate of heart failure"}, {"measure"=>"All-cause mortality", "timeFrame"=>"up to 36 months", "description"=>"Death from all diseases"}, {"measure"=>"KCCQ score", "timeFrame"=>"up to 36 months", "description"=>"The score of patients measured with the Kansas City Cardiomyopathy Questionnaire (KCCQ)"}]}, "oversightModule"=>{"isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Dilated Cardiomyopathy", "Kaposi's Sarcoma-Associated Herpesvirus Infection"]}, "descriptionModule"=>{"briefSummary"=>"Evaluating the efficacy of sirolimus (compared to standard therapy alone) in the treatment of dilated cardiomyopathy infected with Kaposi Sarcoma-associated virus -- a multicenter randomized controlled study.", "detailedDescription"=>"Dilated cardiomyopathy (DCM), defined as left ventricular or biventricular dilation and systolic dysfunction in the absence of either pressure or volume overload or coronary artery disease sufficient to explain the dysfunction, is associated with poor cardiovascular outcome and poor prognosis. Inflammation, activated by viral persistence, was considered as a key trigger factor of cardiac remodeling and thereby the development of DCM. As a risk factor for DCM, Kaposi's sarcoma-associated herpes virus (KSHV) inhibits the type I IFN signaling pathway and thereby aggravates known cardiotropic viruses-induced cardiac dysfunction and inflammatory infiltration. Activated mTOR signaling pathway is a typical feature of KSHV-infected cells, which is the most effective therapeutic target of diseases caused by KSHV infection. Sirolimus, a mTOR inhibitor, is a drug that can effectively treat the KSHV-infected diseases and suppresses the replication of KSHV.Therefore, multicenter large randomized controlled trials are needed to verify the efficacy of sirolimus on patients with DCM infected with KSHV.\n\nThis study aimed to evaluate the effiects of sirolimus on the clinical outcomes of patients with DCM infected with KSHV and provide theoretical evidence for the clinical application of sirolimus in these patients."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"70 years", "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* 18 to 70 years of age;\n* Diagnosed as dilated cardiomyopathy. Specifically, (i) left ventricular ejection fraction \\<45% (\\>2 SD) and/or fractional shortening \\<25% (\\>2 SD), as ascertained by echocardiography, radionuclide scanning, or cardiac magnetic resonance imaging; (ii) left ventricular end-diastolic diameter \\>117% of the predicted value corrected for age and body surface area (Henry's formula), which corresponds to 2 SD of the predicted normal limit +5%; and (iii) In the absence of severe coronary artery disease or valvular disease.\n* KSHV DNA seropositivity;\n* Patients are voluntary and signed informed consent.\n\nExclusion Criteria:\n\n* Allergic to rapamycin or its derivatives；\n* The proportion of neutrophils less than 0.5\\*10\\^9/L or platelet less than 2.5\\*10\\^10/L;\n* Pregnant women or plan to;\n* Participate in any drug clinical trials within 3 months;\n* Serious neurological disease (Alzheimer's disease, Parkinson syndrome, progressive lower limbs or deaf patients);\n* Previous history of cancer or tumor, or pathological examination confirmed precancerous lesions;\n* Patients were not optimally managed."}, "identificationModule"=>{"nctId"=>"NCT06236022", "acronym"=>"SDCMK", "briefTitle"=>"The Effects of Sirolimus in Patients With Dilated Cardiomyopathy Infected With Kaposi Sarcoma-associated Virus", "organization"=>{"class"=>"OTHER", "fullName"=>"Tongji Hospital"}, "officialTitle"=>"The Effects of Sirolimus in Patients With Dilated Cardiomyopathy Infected With Kaposi Sarcoma-associated Virus", "orgStudyIdInfo"=>{"id"=>"TJH-SDCMK"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"NO_INTERVENTION", "label"=>"Control", "description"=>"patients with dilated cardiomyopathy infected with Kaposi sarcoma-associated virus to receive standard DCM therapy"}, {"type"=>"EXPERIMENTAL", "label"=>"Sirolimus", "description"=>"patients with dilated cardiomyopathy infected with Kaposi sarcoma-associated virus to receive sirolimus (at a dose of 2 mg once daily) in addition to standard DCM therapy", "interventionNames"=>["Drug: Sirolimus"]}], "interventions"=>[{"name"=>"Sirolimus", "type"=>"DRUG", "description"=>"at a dose of 2 mg once daily", "armGroupLabels"=>["Sirolimus"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"430030", "city"=>"Wuhan", "state"=>"Hubei", "status"=>"RECRUITING", "country"=>"China", "contacts"=>[{"name"=>"Yanru Zhao, Doctor", "role"=>"CONTACT", "email"=>"zyrecho@163.com", "phone"=>"86-027-83663280"}], "facility"=>"Tongji Hospital", "geoPoint"=>{"lat"=>30.58333, "lon"=>114.26667}}], "centralContacts"=>[{"name"=>"Yanru Zhao, Doctor", "role"=>"CONTACT", "email"=>"zyrecho@163.com", "phone"=>"86-027-83663280"}], "overallOfficials"=>[{"name"=>"Dao Wen Wang, Doctor", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Tongji Hospital"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Tongji Hospital", "class"=>"OTHER"}, "collaborators"=>[{"name"=>"Wuhan Central Hospital", "class"=>"OTHER"}, {"name"=>"Wuhan Fourth Hospital", "class"=>"UNKNOWN"}, {"name"=>"Wuhan University", "class"=>"OTHER"}], "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Prof.", "investigatorFullName"=>"Dao Wen Wang", "investigatorAffiliation"=>"Tongji Hospital"}}}}