Ignite Creation Date:
2025-12-24 @ 5:12 PM
Ignite Modification Date:
2026-02-26 @ 4:16 PM
Study NCT ID:
NCT04197050
Status:
UNKNOWN
Last Update Posted:
2020-01-07
First Post:
2019-11-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Sacubitril/Valsartan on Reduced Right Ventricular Ejection Fraction in Patients With CTD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003240', 'term': 'Connective Tissue Diseases'}], 'ancestors': [{'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C549068', 'term': 'sacubitril and valsartan sodium hydrate drug combination'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-02-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2022-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-01-04', 'studyFirstSubmitDate': '2019-11-27', 'studyFirstSubmitQcDate': '2019-12-10', 'lastUpdatePostDateStruct': {'date': '2020-01-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Exercise tolerance', 'timeFrame': 'change between 1 and 6 months after treatment', 'description': '6 minutes walking test'}, {'measure': 'Fibrosis Assessment', 'timeFrame': 'change between 1 and 6 months after treatment', 'description': 'LGE assessment'}, {'measure': 'Fibrosis Assessment', 'timeFrame': 'change between 1 and 6 months after treatment', 'description': 'ECV quantification'}], 'secondaryOutcomes': [{'measure': 'CTD activity', 'timeFrame': 'change between 1 and 6 months after treatment', 'description': 'antinuclear antibody'}, {'measure': 'Cardiovascular Mortality Rate', 'timeFrame': 'change between 1 and 6 months after treatment', 'description': 'all cause of death'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Connective Tissue Diseases', 'sacubitril/valsartan', 'Cardiovascular Magnetic Resonance', 'Extracellular Volume', 'exercise tolerance'], 'conditions': ['Myocardial Injury', 'Connective Tissue Diseases']}, 'referencesModule': {'references': [{'pmid': '28407841', 'type': 'BACKGROUND', 'citation': 'Braun J, Kruger K, Manger B, Schneider M, Specker C, Trappe HJ. Cardiovascular Comorbidity in Inflammatory Rheumatological Conditions. Dtsch Arztebl Int. 2017 Mar 24;114(12):197-203. doi: 10.3238/arztebl.2017.0197.'}, {'pmid': '25492941', 'type': 'BACKGROUND', 'citation': 'Leal GN, Silva KF, Franca CM, Lianza AC, Andrade JL, Campos LM, Bonfa E, Silva CA. Subclinical right ventricle systolic dysfunction in childhood-onset systemic lupus erythematosus: insights from two-dimensional speckle-tracking echocardiography. Lupus. 2015 May;24(6):613-20. doi: 10.1177/0961203314563135. Epub 2014 Dec 8.'}, {'pmid': '25992267', 'type': 'BACKGROUND', 'citation': 'Hassoun PM. The right ventricle in scleroderma (2013 Grover Conference Series). Pulm Circ. 2015 Mar;5(1):3-14. doi: 10.1086/679607.'}, {'pmid': '15986394', 'type': 'BACKGROUND', 'citation': 'Wigley FM, Lima JA, Mayes M, McLain D, Chapin JL, Ward-Able C. 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Chest. 2010 Nov;138(5):1234-9. doi: 10.1378/chest.09-2815.'}, {'pmid': '22133851', 'type': 'BACKGROUND', 'citation': 'van de Veerdonk MC, Kind T, Marcus JT, Mauritz GJ, Heymans MW, Bogaard HJ, Boonstra A, Marques KM, Westerhof N, Vonk-Noordegraaf A. Progressive right ventricular dysfunction in patients with pulmonary arterial hypertension responding to therapy. J Am Coll Cardiol. 2011 Dec 6;58(24):2511-9. doi: 10.1016/j.jacc.2011.06.068.'}, {'pmid': '30070061', 'type': 'BACKGROUND', 'citation': 'Guo Q, Wu LM, Wang Z, Shen JY, Su X, Wang CQ, Gong XR, Yan QR, He Q, Zhang W, Xu JR, Jiang M, Pu J. Early Detection of Silent Myocardial Impairment in Drug-Naive Patients With New-Onset Systemic Lupus Erythematosus: A Three-Center Prospective Study. Arthritis Rheumatol. 2018 Dec;70(12):2014-2024. doi: 10.1002/art.40671.'}, {'pmid': '27686019', 'type': 'BACKGROUND', 'citation': 'Owens AT, Brozena S, Jessup M. Neprilysin Inhibitors: Emerging Therapy for Heart Failure. Annu Rev Med. 2017 Jan 14;68:41-49. doi: 10.1146/annurev-med-052915-015509. Epub 2016 Sep 21.'}, {'pmid': '25176015', 'type': 'BACKGROUND', 'citation': 'McMurray JJ, Packer M, Desai AS, Gong J, Lefkowitz MP, Rizkala AR, Rouleau JL, Shi VC, Solomon SD, Swedberg K, Zile MR; PARADIGM-HF Investigators and Committees. Angiotensin-neprilysin inhibition versus enalapril in heart failure. N Engl J Med. 2014 Sep 11;371(11):993-1004. doi: 10.1056/NEJMoa1409077. Epub 2014 Aug 30.'}, {'pmid': '28455343', 'type': 'BACKGROUND', 'citation': 'Yancy CW, Jessup M, Bozkurt B, Butler J, Casey DE Jr, Colvin MM, Drazner MH, Filippatos GS, Fonarow GC, Givertz MM, Hollenberg SM, Lindenfeld J, Masoudi FA, McBride PE, Peterson PN, Stevenson LW, Westlake C. 2017 ACC/AHA/HFSA Focused Update of the 2013 ACCF/AHA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Failure Society of America. Circulation. 2017 Aug 8;136(6):e137-e161. doi: 10.1161/CIR.0000000000000509. Epub 2017 Apr 28. No abstract available.'}, {'pmid': '27206819', 'type': 'BACKGROUND', 'citation': 'Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JGF, Coats AJS, Falk V, Gonzalez-Juanatey JR, Harjola VP, Jankowska EA, Jessup M, Linde C, Nihoyannopoulos P, Parissis JT, Pieske B, Riley JP, Rosano GMC, Ruilope LM, Ruschitzka F, Rutten FH, van der Meer P; ESC Scientific Document Group. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC)Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur Heart J. 2016 Jul 14;37(27):2129-2200. doi: 10.1093/eurheartj/ehw128. Epub 2016 May 20. No abstract available.'}, {'pmid': '30415601', 'type': 'BACKGROUND', 'citation': 'Velazquez EJ, Morrow DA, DeVore AD, Duffy CI, Ambrosy AP, McCague K, Rocha R, Braunwald E; PIONEER-HF Investigators. Angiotensin-Neprilysin Inhibition in Acute Decompensated Heart Failure. N Engl J Med. 2019 Feb 7;380(6):539-548. doi: 10.1056/NEJMoa1812851. Epub 2018 Nov 11.'}, {'pmid': '29239515', 'type': 'BACKGROUND', 'citation': 'Pascual-Figal D, Wachter R, Senni M, Belohlavek J, Noe A, Carr D, Butylin D. Rationale and design of TRANSITION: a randomized trial of pre-discharge vs. post-discharge initiation of sacubitril/valsartan. ESC Heart Fail. 2018 Apr;5(2):327-336. doi: 10.1002/ehf2.12246. Epub 2017 Dec 14.'}, {'pmid': '29968754', 'type': 'BACKGROUND', 'citation': 'Jiang M, Wang Z, Su X, Gong X, Pu J, Wu L, Liu C, Yao Q, Kong L, Xu J, He B. The Significance of Interstitial Fibrosis on Left Ventricular Function in Hypertensive versus Hypertrophic Cardiomyopathy. Sci Rep. 2018 Jul 3;8(1):9995. doi: 10.1038/s41598-018-27049-1.'}, {'pmid': '27579709', 'type': 'BACKGROUND', 'citation': 'Jiang M, Xu J, He B. Diffuse Epicardial Involvement on Cardiac Magnetic Resonance Imaging. JAMA Cardiol. 2016 Oct 1;1(7):845-846. doi: 10.1001/jamacardio.2016.2557. No abstract available.'}, {'pmid': '27111161', 'type': 'BACKGROUND', 'citation': 'Jiang M, Pu J, Yao J, Xu J, He B. An acromegaly-induced cardiomyopathy mimicking amyloidosis: (Manifestation of acromegaly-induced-cardiomyopathy). Int J Cardiol. 2016 Jul 15;215:60-1. doi: 10.1016/j.ijcard.2016.04.043. Epub 2016 Apr 13. No abstract available.'}, {'pmid': '27436293', 'type': 'BACKGROUND', 'citation': 'Leng S, Jiang M, Zhao XD, Allen JC, Kassab GS, Ouyang RZ, Tan JL, He B, Tan RS, Zhong L. Three-Dimensional Tricuspid Annular Motion Analysis from Cardiac Magnetic Resonance Feature-Tracking. Ann Biomed Eng. 2016 Dec;44(12):3522-3538. doi: 10.1007/s10439-016-1695-2. Epub 2016 Jul 19.'}, {'pmid': '28552325', 'type': 'BACKGROUND', 'citation': 'Wu LM, An DL, Yao QY, Ou YZ, Lu Q, Jiang M, Xu JR. Hypertrophic cardiomyopathy and left ventricular hypertrophy in hypertensive heart disease with mildly reduced or preserved ejection fraction: insight from altered mechanics and native T1 mapping. Clin Radiol. 2017 Oct;72(10):835-843. doi: 10.1016/j.crad.2017.04.019. Epub 2017 May 25.'}]}, 'descriptionModule': {'briefSummary': 'Heart failure, one of the leading causes of connective tissue disease (CTD) mortality, has attracted increasing attention. Currently, no known study had focused on the effect of sacubitril/valsartan on right ventricular dysfunction and in the systemic disease induced heart disease. We aimed to observe the effect of sacubitril/valsartan on primary endpoints (6 minutes walking test and myocardial fibrosis) in CTD patients with right ventricular ejection fraction reduction (RV-HFrEF).', 'detailedDescription': 'Patients with CTD frequently exhibit multi-organ pathophysiological and functional damage. Heart failure, one of the leading causes of CTD mortality, has attracted increasing attention. Mostly, patients with CTD present with nonspecific cardiac symptoms, normal ECG, and preserved left ventricular ejection fraction (LVEF) and therefore do not receive an early cardiac diagnosis and treatment. Pulmonary arterial hypertension (PAH), right ventricular (RV) dilatation and hypertrophy might become the first and the most frequent cardiac findings. Sacubitril/valsartan, an angiotensin receptor-neprilysin inhibitors, is a "superstar" which inhibits both neprilysin and renin-angiotensin aldosterone system that closely related to the heart failure mechanism. It has been strongly recommended as class I drug in treating the patient with chronic HFrEF from 2017 ACC/AHA/HFSA heart failure guideline for the ability of dramatically reduce the cardiovascular mortality rate.\n\nCardiovascular magnetic resonance (CMR) is able to depict myocardial characteristics from structure to tissue properties using cine and late gadolinium enhancement (LGE) sequences. Newly developed imaging studies to date include T1 mapping and T1-derived extracellular volume estimation. All the previous studies in CTD have been restricted to patients with advanced cardiac involvement.\n\nTogether with clinical assessment and multi-imaging tests, the aim of the present study is going to observe the effect of sacubitril/valsartan on primary endpoints (6 minutes walking test and myocardial fibrosis) in CTD patients with RV-HFrEF.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age between 18-75 years old.\n* confirmed CTD（including systemic lupus erythematosus, myositis, polymyositis, systemic sclerosis, sarcoid, Sjögren's syndrome or mixed connective tissue disease）\n* SLEDAI ≤ 6 in patients with SLE or ESR ≤ 30 in patients with SSc\n* already have OPT for CTD at least 3 month\n* RVEF ≤ 45%\n* Providing written informed consent\n\nExclusion Criteria:\n\n* Documented coronary artery disease or prior angiography for coronary artery disease (\\>50% stenosis).\n* Patients with known congenital heart disease or other systemic diseases that might induce RVrEF.\n* Patients with standard metallic contraindications to CMR or an estimated glomerular filtration rate \\< 30 ml/min/1.73 m2."}, 'identificationModule': {'nctId': 'NCT04197050', 'acronym': 'EARLY-MYO-CTD', 'briefTitle': 'Effect of Sacubitril/Valsartan on Reduced Right Ventricular Ejection Fraction in Patients With CTD', 'organization': {'class': 'OTHER', 'fullName': 'RenJi Hospital'}, 'officialTitle': 'Effect of Sacubitril/Valsartan on Right Ventricular Dysfunctioning Patients With Connective Tissue Disease', 'orgStudyIdInfo': {'id': '2019-11-01R'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'sacubitril/valsartan group', 'description': 'The diagnosis of CTD was made based on the clinical classification criteria. The patient was diagnosed by an echocardiography demonstration, when RVEF is suggested lower or equal to 45%, the patient will be considered a candidate after consent is signed. sacubitril/valsartan will be given.', 'interventionNames': ['Drug: Sacubitril / Valsartan Oral Tablet']}, {'type': 'NO_INTERVENTION', 'label': 'control group', 'description': 'The diagnosis of CTD was made based on the clinical classification criteria. The patient was diagnosed by an echocardiography demonstration, when RVEF is suggested lower or equal to 45%, the patient will be considered a candidate after consent is signed. Valsartan will be given.'}], 'interventions': [{'name': 'Sacubitril / Valsartan Oral Tablet', 'type': 'DRUG', 'otherNames': ['CMR examination'], 'description': 'After recruiting participants and collecting the baseline information, sacubitril/valsartan group will receive sacubitril/valsartan and optimal pharmaceutical treatment (OPT). The control group will receive valsartan and OPT. A CMR scan and a post-processed imaging procedure will later be carried on in order to detect the cardiac impairment.', 'armGroupLabels': ['sacubitril/valsartan group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200127', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Renji Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Meng Jiang, MD', 'role': 'CONTACT', 'email': 'jiangmeng0919@163.com', 'phone': '+86 13788912766'}], 'overallOfficials': [{'name': 'Meng Jiang, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'RenJi Hospital, School of Medicine, Shanghai Jiantong University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RenJi Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}