Cardiac Structure and Function in Patients with Cystic Fibrosis

NCT06084468 | Active Not Recruiting DMC

• 1 other identifier: Cardiac-CF
• Study Type: observational
• Target: 104
• Locations: 1 country
• Sites: 2

Brief Summary

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).

Conditions

Cystic Fibrosis; Cystic Fibrosis-related Diabetes; Cystic Fibrosis, Pulmonary; Cystic Fibrosis of Pancreas; Cystic Fibrosis Gastrointestinal Disease; Cystic Fibrosis Modifier 1; Left Ventricular Dysfunction; Heart Failure; Heart Failure, Systolic; Heart Failure, Diastolic; Myocardial Infarction; Stroke; Heart Diseases

Keywords

Cystic Fibrosis; Echocardiography; Advanced echocardiography; Biomarkers; Cardiovascular disease; Cardiovascular mortality; Mortality

Outcome Measures

Primary Outcomes (4)

• Rate of cardiovascular mortality

  2, 5 and 10 year follow-up

• Incidence of myocardial infarction

  2, 5 and 10 year follow-up

• Incidence of coronary revascularization (percutaneous coronary intervention/coronary artery bypass graft)

  2, 5 and 10 year follow-up

• Incidence of heart failure

  2, 5 and 10 year follow-up

Secondary Outcomes (4)

• Rate of all-cause mortality

  2, 5 and 10 year follow-up

• Incidence of stroke

  2, 5 and 10 year follow-up

• Number of Participants with admission with cardiac heart failure

  2, 5 and 10 year follow-up

• Number of Participants with admission with stroke

  2, 5 and 10 year follow-up

Study Arms (2)

Cystic Fibrosis

Adult CF patients (\>/=18 years) at Department of Infectious Diseases, Copenhagen University Hospital, will be invited to participate in this study. Potential participants are invited by their regular CF physician to participate during routine visits at the CF outpatient clinic. Inclusion criteria: Diagnosis of CF and age \>/=18 years. Exclusion criteria: * Lung transplanted patients * Inability to cooperate * Inability to understand and sign informed consent

Control group

The control group will consist of a random sample of age- and sex-matched participants from the general population examined in the 5th Copenhagen City Heart Study, 2011-2014 (ClinicalTrials.gov identifier NCT02993172, I-Suite no. 03741, National Committee on Health Research Ethics approval HEH-2015-045). Existing data from the Copenhagen City Heart Study will be transferred to the current study and will include personal identification number from the Central Office of Civil Registration, echocardiographic assessments, electrocardiograms as well as health related data (health conditions including symptoms, risk factors for cardiovascular disease, medication, prior clinical and/or paraclinical assessments including blood test results and procedures relevant to psoriasis and potential heart disease).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult CF patients (≥18 years) at Department of Infectious Diseases, CF Centre, Rigshospitalet, will be invited consecutively to participate in this study regardless of health status. Potential participants are invited by their regular CF physician to participate during routine visits at the CF Centre outpatient clinic.

You may qualify if:

• CF diagnosis
• Age ≥ 18 years

You may not qualify if:

• Prior lung transplant
• Inability to cooperate
• Inability to understand and sign informed consent

Sponsors & Collaborators

• Herlev and Gentofte Hospital: lead
• Copenhagen University Hospital, Denmark: collaborator

Study Sites (2)

Department of Cardiology, Herlev and Gentofte University Hospital, University of Copenhagen

Hellerup, Copenhagen, 2900, Denmark

Location

Department of Infectious Diseases, University Hospital of Copenhagen, Cystic Fibrosis Centre, Copenhagen, Denmark

Copenhagen, 2100, Denmark

Location

Related Publications (13)

• 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.

  PMID: 30281026 BACKGROUND

• 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.

  PMID: 8689654 BACKGROUND

• 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.

  PMID: 8739239 BACKGROUND

• 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.

  PMID: 10562333 BACKGROUND

• 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.

  PMID: 17112538 BACKGROUND

• 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.

  PMID: 12216270 BACKGROUND

• Weitzenblum E, Chaouat A. Cor pulmonale. Chron Respir Dis. 2009;6(3):177-85. doi: 10.1177/1479972309104664.

  PMID: 19643833 BACKGROUND

• 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.

  PMID: 29398489 BACKGROUND

• 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.

  PMID: 25866147 BACKGROUND

• 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.

  PMID: 1995219 BACKGROUND

• 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.

  PMID: 21764552 BACKGROUND

• 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.

  PMID: 34513358 BACKGROUND

• 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.

  PMID: 11035678 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Hemoglobin A1c (HbA1c), hemoglobin level, fasting plasma glucose, alanine aminotransferase (ALAT), cholesterol, triglyceride levels, creatinine, potassium, sodium, thyroid-stimulating hormone, high-sensitivity C-reactive protein, high-sensitivity troponin (TnT) and N-terminal pro brain natriuretic peptide (NT-pro-BNP).

MeSH Terms

Conditions

Cystic Fibrosis; Ventricular Dysfunction, Left; Heart Failure; Heart Failure, Systolic; Heart Failure, Diastolic; Myocardial Infarction; Stroke; Heart Diseases; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Ventricular Dysfunction; Myocardial Ischemia; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Tor Biering-Sørensen, Professor MD PhD MPH

  Department of Cardiology, Department of Biomedical Sciences, Herlev and Gentofte University Hospital, University of Copenhagen

  PRINCIPAL INVESTIGATOR

• Susanne D Poulsen, MD DMSc

  Viro-immunology Research Unit, Department of Infectious Diseases 8632, Copenhagen University Hospital Rigshospitalet, University of Copenhagen

  STUDY DIRECTOR

• Daniel Faurholt-Jepsen, MD PhD

  CF Centre Copenhagen University Hospital Rigshospitalet

  STUDY DIRECTOR

• Terese L Katzenstein, MD PhD DMSc

  CF Centre Copenhagen University Hospital Rigshospitalet

  STUDY DIRECTOR

• Tacjana Pressler, MD

  CF Centre Copenhagen University Hospital Rigshospitalet

  STUDY DIRECTOR

• Rebekka F Thudium, MD PhD

  CF Centre Copenhagen University Hospital Rigshospitalet

  STUDY DIRECTOR

• Lisa S Duus, MD

  Department of Cardiology, Department of Biomedical Sciences, Herlev and Gentofte University Hospital, University of Copenhagen

  STUDY DIRECTOR

• Maria Dons, MD

  Department of Cardiology, Department of Biomedical Sciences, Herlev and Gentofte University Hospital, University of Copenhagen

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 10, 2023
• First Posted: October 16, 2023
• Study Start: January 1, 2023
• Primary Completion: March 1, 2023
• Study Completion (Estimated): March 1, 2032
• Last Updated: March 13, 2025

Record last verified: 2024-11

Locations

DK (2)