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Towards Understanding the Phenotype of Cardiovascular Disease in CKD - TRUE-Type-CKD Study (TRUE-TypeCKD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03749551
Recruitment Status : Recruiting
First Posted : November 21, 2018
Last Update Posted : November 21, 2018
Sponsor:
Collaborator:
Kerckhoff Klinik
Information provided by (Responsible Party):
Valentina Puentmann, Johann Wolfgang Goethe University Hospital

Brief Summary:
Premature cardiovascular disease (CVD) is the leading cause of death in patients with kidney disease (CKD). Excessive cardiac mortality is thought to be secondary to non-atherosclerotic processes, with left ventricular (LV) hypertrophy (LVH) and remodelling being the predominant phenotypical features. Along with other risk factors, subclinical ischaemia and haemodynamic perturbations associated with haemodialysis (HD) are thought to contribute to the ultimate development of LV systolic and diastolic dysfunction. The development of these adverse features reflects a specific cardiomyopathy due to CKD and subsequently, to uraemia. Patients receiving hemodialysis (HD) have a higher incidence rate of heart failure (predominantly with preserved ejection fraction), with phenotypically eccentric hypertrophic remodelling, systolic and diastolic dysfunction as well as high rate of interstitial myocardial fibrosis. Detection and ultimately reversal of the development of this CKD-related cardiomyopathy are important goals for improving the CVD, morbidity and mortality of CKD patients.The objectives of this study are, firstly, to investigate the complex myocardial phenotype in patients with various stages of CKD, secondly, to relate the CMR-measures to outcome, and thirdly, to be able to estimate the effects of chronic uremia/hypervolemia. Deciphering the predominant driver of remodelling on an individual level may help to personalise anti-remodelling strategies. Native T1 and T2 mapping imaging provide non-invasive imaging tools to detect myocardial fibrosis and oedema, respectively. Prognostic associations of these measures may clarify the relative prevalence of adverse phenotype and their relative contribution to adverse events and poor outcome. The role of chronic water retention and uraemia may be associated with interstitial myocardial oedema promoting further the remodelling process.

Condition or disease Intervention/treatment
Heart Failure Cardiomyopathies Chronic Kidney Diseases Hypertrophy, Left Ventricular Diagnostic Test: cardiac magnetic resonance (CMR) post haemodialysis

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Study Type : Observational
Estimated Enrollment : 215 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: TowaRds Understanding the phEnoTYPEs of Cardiovascular Dysfunction in Patients With Chronic Kidney Disease and HaemoDialysis Using Cardiovascular Magnetic Resonance Imaging - TRUE-Type-CKD Study
Actual Study Start Date : March 28, 2018
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : March 1, 2027

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Participants
diagnostic test - patients serving as their own controls
Diagnostic Test: cardiac magnetic resonance (CMR) post haemodialysis
patients will undergo a second CMR scan immediately after receiving haemodialysis (native CMR study)




Primary Outcome Measures :
  1. survival [ Time Frame: 1 year ]
    number of deaths

  2. survival [ Time Frame: 5 year ]
    number of deaths

  3. rate of death due to cardiovascular causes [ Time Frame: 1 year ]
    number of participants died due to death due to myocardial infarction, sudden cardiac death, heart failure

  4. rate of death due to cardiovascular causes [ Time Frame: 5 year ]
    number of participants died due to death due to myocardial infarction, sudden cardiac death, heart failure


Secondary Outcome Measures :
  1. rate of heart failure events [ Time Frame: 1 year ]
    number of participants with heart failure death and hospitalisation due to heart failure

  2. rate of heart failure events [ Time Frame: 5 year ]
    number of participants with heart failure death and hospitalisation due to heart failure


Other Outcome Measures:
  1. Change in native T1 and T2 (in msec) pre and post haemodialysis [ Time Frame: 24 hour ]
    measurement of change in magnetisation relaxation (in msec)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients with established diagnosis of chronic kidney disease
Criteria

Inclusion Criteria:

  1. Adults >18 years of age
  2. Able to provide informed consent
  3. Chronic kidney disease stages G3-5 (eGFR<59 ml/min/1.73m2)

Exclusion Criteria:

  1. Absence of absolute clinical indication for MRI studies (MR unsafe or incompatible devices, aneurysm clips, cochlear implants, loose metal foreign objects)
  2. Absolute contraindications to gadolinium contrast agent (previous allergic reaction or pregnancy),

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03749551


Contacts
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Contact: Valentina Puentmann, MD, PhD +4969630184454 cvi-research@kgu.de
Contact: Franziska Weis +4969630184454 cvi-research@kgu.de

Locations
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Germany
University Hospital Frankfurt Recruiting
Frankfurt, Hessen, Germany, Frankfurt am Main
Contact: Valentina Puentmann, MD, PhD    +4969186760    cvi-research@kgu.de   
Contact: Franziska Weis    +4969630184454    cvi-research@kgu.de   
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospital
Kerckhoff Klinik
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Responsible Party: Valentina Puentmann, Principal Investigator, Clinical professor, Johann Wolfgang Goethe University Hospital
ClinicalTrials.gov Identifier: NCT03749551    
Other Study ID Numbers: TrueTypeCKD 4/17
First Posted: November 21, 2018    Key Record Dates
Last Update Posted: November 21, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Cardiomyopathies
Hypertrophy, Left Ventricular
Hypertrophy
Heart Diseases
Cardiovascular Diseases
Urologic Diseases
Renal Insufficiency
Pathological Conditions, Anatomical
Cardiomegaly