Stroke Clinical Trial
Official title:
Cardiac Structure and Function in Patients With Cystic Fibrosis
Verified date | October 2023 |
Source | Herlev and Gentofte Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
In a prospective observational cohort study (n = 100), the investigators aim to assess the correlation between cardiac biomarkers, advanced echocardiography and cystic fibrosis genotype and severity and determine whether these are prognostic markers of heart disease in patients suffering from cystic fibrosis (CF).
Status | Active, not recruiting |
Enrollment | 104 |
Est. completion date | March 1, 2032 |
Est. primary completion date | March 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - CF diagnosis - Age = 18 years Exclusion Criteria: - Prior lung transplant - Inability to cooperate - Inability to understand and sign informed consent |
Country | Name | City | State |
---|---|---|---|
Denmark | Department of Infectious Diseases, University Hospital of Copenhagen, Cystic Fibrosis Centre, Copenhagen, Denmark | Copenhagen | |
Denmark | Department of Cardiology, Herlev and Gentofte University Hospital, University of Copenhagen | Hellerup | Copenhagen |
Lead Sponsor | Collaborator |
---|---|
Herlev and Gentofte Hospital | Copenhagen University Hospital, Denmark |
Denmark,
Bright-Thomas RJ, Webb AK. The heart in cystic fibrosis. J R Soc Med. 2002;95 Suppl 41(Suppl 41):2-10. No abstract available. — View Citation
Corriveau S, Sykes J, Stephenson AL. Cystic fibrosis survival: the changing epidemiology. Curr Opin Pulm Med. 2018 Nov;24(6):574-578. doi: 10.1097/MCP.0000000000000520. — View Citation
Duan D, Ye L, Britton F, Miller LJ, Yamazaki J, Horowitz B, Hume JR. Purinoceptor-coupled Cl- channels in mouse heart: a novel, alternative pathway for CFTR regulation. J Physiol. 1999 Nov 15;521 Pt 1(Pt 1):43-56. doi: 10.1111/j.1469-7793.1999.00043.x. — View Citation
Eising JB, van der Ent CK, Teske AJ, Vanderschuren MM, Uiterwaal CSPM, Meijboom FJ. Young patients with cystic fibrosis demonstrate subtle alterations of the cardiovascular system. J Cyst Fibros. 2018 Sep;17(5):643-649. doi: 10.1016/j.jcf.2017.12.009. Epub 2018 Feb 3. — View Citation
Florea VG, Florea ND, Sharma R, Coats AJ, Gibson DG, Hodson ME, Henein MY. Right ventricular dysfunction in adult severe cystic fibrosis. Chest. 2000 Oct;118(4):1063-8. doi: 10.1378/chest.118.4.1063. — View Citation
Gao Z, Sun HY, Lau CP, Chin-Wan Fung P, Li GR. Evidence for cystic fibrosis transmembrane conductance regulator chloride current in swine ventricular myocytes. J Mol Cell Cardiol. 2007 Jan;42(1):98-105. doi: 10.1016/j.yjmcc.2006.10.002. Epub 2006 Nov 16. — View Citation
Johnson GL, Kanga JF, Moffett CB, Noonan JA. Changes in left ventricular diastolic filling patterns by Doppler echocardiography in cystic fibrosis. Chest. 1991 Mar;99(3):646-50. doi: 10.1378/chest.99.3.646. — View Citation
Labombarda F, Pellissier A, Ellafi M, Creveuil C, Ribault V, Laurans M, Guillot M, Bergot E, Grollier G, Milliez P, Zalcman G, Saloux E. Myocardial strain assessment in cystic fibrosis. J Am Soc Echocardiogr. 2011 Sep;24(9):1037-45. doi: 10.1016/j.echo.2011.06.004. Epub 2011 Jul 18. — View Citation
Sellers ZM, McGlocklin L, Brasch A. Strain rate echocardiography uncovers subclinical left ventricular dysfunction in cystic fibrosis. J Cyst Fibros. 2015 Sep;14(5):654-60. doi: 10.1016/j.jcf.2015.03.010. Epub 2015 Apr 9. — View Citation
Shah PH, Lee JH, Salvi DJ, Rabbani R, Gavini DR, Hamid P. Cardiovascular System Involvement in Cystic Fibrosis. Cureus. 2021 Jul 29;13(7):e16723. doi: 10.7759/cureus.16723. eCollection 2021 Jul. — View Citation
Tilly BC, Bezstarosti K, Boomaars WE, Marino CR, Lamers JM, de Jonge HR. Expression and regulation of chloride channels in neonatal rat cardiomyocytes. Mol Cell Biochem. 1996 Apr 12-26;157(1-2):129-35. doi: 10.1007/BF00227891. — View Citation
Warth JD, Collier ML, Hart P, Geary Y, Gelband CH, Chapman T, Horowitz B, Hume JR. CFTR chloride channels in human and simian heart. Cardiovasc Res. 1996 Apr;31(4):615-24. — View Citation
Weitzenblum E, Chaouat A. Cor pulmonale. Chron Respir Dis. 2009;6(3):177-85. doi: 10.1177/1479972309104664. — View Citation
* Note: There are 13 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of cardiovascular mortality | 2, 5 and 10 year follow-up | ||
Primary | Incidence of myocardial infarction | 2, 5 and 10 year follow-up | ||
Primary | Incidence of coronary revascularization (percutaneous coronary intervention/coronary artery bypass graft) | 2, 5 and 10 year follow-up | ||
Primary | Incidence of heart failure | 2, 5 and 10 year follow-up | ||
Secondary | Rate of all-cause mortality | 2, 5 and 10 year follow-up | ||
Secondary | Incidence of stroke | 2, 5 and 10 year follow-up | ||
Secondary | Number of Participants with admission with cardiac heart failure | 2, 5 and 10 year follow-up | ||
Secondary | Number of Participants with admission with stroke | 2, 5 and 10 year follow-up |
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