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Romanian Kidney Transplant Cardiovascular Risk Registry (ROKET-CV)

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ClinicalTrials.gov Identifier: NCT04451356
Recruitment Status : Recruiting
First Posted : June 30, 2020
Last Update Posted : June 30, 2020
Information provided by (Responsible Party):
Dimitrie Siriopol, Grigore T. Popa University of Medicine and Pharmacy

Brief Summary:

Kidney transplantation (KT) represents the best treatment for patients with end-stage kidney disease, being associated with improved outcomes and reduced mortality. Although the survival benefit with KT is mostly attributable to reduction in cardiovascular (CV) disease, KT recipients continue to remain at higher risk for CV-related morbidity and mortality when compared with the general population. Additionally, CV events represent the leading cause of death in KT recipients with a functioning allograft. KT recipients have high rates of hospitalization for myocardial infarction, congestive heart failure, dysrhythmias, stroke, malignant hypertension, and cardiac arrest. Significant amounts of research have been aimed at reducing event rates, primarily aimed at understanding prevalent risk factors, defining outcomes, and application of guideline-based care.

The post-KT milieu represents the confluence of several traditional and nontraditional CV risk factors contributing to the significant CV risk in this population. CV disease remains an understudied and undertreated source of morbidity and mortality in KT patients. Patients with chronic kidney disease (CKD) are generally excluded from major cardiovascular outcome trials, and this phenomenon of aversion to including patients with CKD in CV trials and providing appropriate goal-directed medical and interventional therapies (renalism) extends into KT .

The main aim of this study is to evaluate holistically the CV risk in a KT population. The investigators will compare bioimpedance spectroscopy derived fluid status parameters (overhydration, total body water, extracellular water and intracellular water) with clinical evaluation, lung ultrasonography, pulse wave velocity, different biomarkers, and echocardiographic characteristics and also to determine the impact of these parameters on renal and CV outcomes in the same population.

Condition or disease Intervention/treatment
Kidney Transplant; Complications Cardiovascular Diseases Device: Bioimpedance Spectroscopy Device: Arterial Stiffness Diagnostic Test: Echocardiography Diagnostic Test: Lung ultrasonography

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 36 Months
Official Title: The Complex Evaluation of the Cardiovascular Risk in the Kidney Transplant Patients
Actual Study Start Date : February 1, 2020
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

Intervention Details:
  • Device: Bioimpedance Spectroscopy
    This analysis will be performed at baseline using the portable whole-body multifrequency bioimpedance analysis device (BCM®Body Composition Monitor - Fresenius Medical Care D GmbH). The technique involves attaching electrodes to the patient's forearm and ipsilateral ankle, with the patient in a supine position. The BCM® measures the body resistance and reactance to electrical currents of 50 discrete frequencies, ranging between 5 and 1000 kHz. Based on a fluid model using these resistances, the extracellular water (ECW), the intracellular water (ICW) and the total body water (TBW) are calculated. These volumes are then used to determine the amount of fluid overload. All calculations are automatically performed by the software of the BCM® device. In addition, this analysis will provide the LTI and FTI for the included patients.
  • Device: Arterial Stiffness
    Arterial stiffness assessment will be performed by applanation tonometry (SphygmoCorTM; PWV Inc., Westmead, Sydney, Australia) with the patient being recumbent, 10 minutes before the measures were done. The carotid and femoral pulse will be acquired by applanation tonometry sequentially, allowing a single operator to acquire the measurement. The transit time from the R-wave of the simultaneously acquired electrocardiogram to the foot of the carotid and femoral pulse is measured. The difference acquired electrocardiogram to the foot of the carotid and femoral pulse is measured. The difference between these 2 transit times is divided by distances measured from the body surface to estimate the arterial path length in order to calculate carotid-femoral PWV.
  • Diagnostic Test: Echocardiography
    Echocardiographic evaluations will be made in each patient at baseline. All echocardiographic measurements will be carried out according to the recommendations of the American Society of Echocardiography by an observer unaware of the lung ultrasound and bioimpedance results. Echocardiographic evaluation will provide information about cardiac anatomy (e.g. volumes, geometry, mass) and function (e.g. left ventricular function and wall motion, valvular function, right ventricular function, pulmonary artery pressure, pericardium).
  • Diagnostic Test: Lung ultrasonography
    Examinations will be performed in the supine position. Scanning of the anterior and lateral chest will be performed on both sides of the chest, from the second to the fourth (on the right side to the fifth) intercostal spaces, at parasternal to mid-axillary lines. B-lines will be recorded in each intercostal space and were defined as a hyperechoic, coherent US bundle at narrow basis going from the transducer to the limit of the screen. B-lines starting from the pleural line can be either localized or scattered to the whole lung and be present as isolated or multiple artifacts. The sum of B-lines produces a score reflecting the extent of lung water accumulation (0 being no detectable B-line).

Primary Outcome Measures :
  1. Composite Renal Outcome [ Time Frame: 36 months ]
    Doubling of creatinine or dialysis initiation.

  2. Composite Cardiovascular Outcome [ Time Frame: 36 months ]
    Time to first non-fatal myocardial infarction, non-fatal stroke, hospitalization for heart failure, or cardiovascular death

Secondary Outcome Measures :
  1. Chronic kidney disease progression [ Time Frame: 36 months ]
    The impact of baseline characteristics on eGFR (as assessed by the CKD-EPI formula) evolution

  2. Proteinuria progression [ Time Frame: 36 months ]
    The impact of baseline characteristics on proteinuria (as assessed by the urine protein to creatinine ratio) evolution

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Kidney Transplant Recipients

Inclusion Criteria:

  1. age>18 years;
  2. Kidney Transplant Recipient.

Exclusion Criteria:

  1. metallic joint prostheses, cardiac stent or pacemakers, decompensated cirrhosis, pregnancy and limb amputations (due to bioimpedance technique limitations);
  2. no prior diagnosis of pulmonary fibrosis, pneumectomy or massive pleural effusion (due to lung ultrasonography limitations);
  3. active systemic infections (due to difficulties in the interpretation of nespecific inflammation biomarkers in this type of patients);
  4. absence of congenital heart disease;
  5. eGFR below 30 ml/min/1.73m2;
  6. KT vintage of at least 6 months.

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): NCT04451356

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Contact: Dimitrie Siriopol +40740138874 dimitrie.siriopol@yahoo.com

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"Dr. C.I. Parhon" Hospital Recruiting
Iasi, Romania
Contact: Dimitrie Siriopol         
Sponsors and Collaborators
Grigore T. Popa University of Medicine and Pharmacy
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Study Chair: Adrian Covic, Prof Grigore T. Popa University of Medicine and Pharmacy, Iasi
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Responsible Party: Dimitrie Siriopol, Associate Professor, Grigore T. Popa University of Medicine and Pharmacy
ClinicalTrials.gov Identifier: NCT04451356    
Other Study ID Numbers: UMF
First Posted: June 30, 2020    Key Record Dates
Last Update Posted: June 30, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dimitrie Siriopol, Grigore T. Popa University of Medicine and Pharmacy:
Kidney Transplant
Bioimpedance Spectroscopy
Arterial stiffness
Additional relevant MeSH terms:
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Cardiovascular Diseases