Romanian Kidney Transplant Cardiovascular Risk Registry

NCT04451356 | Unknown DMC

• 1 other identifier: UMF
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Transplant; Complications; Cardiovascular Diseases

Keywords

Kidney Transplant; Bioimpedance Spectroscopy; Arterial stiffness

Outcome Measures

Primary Outcomes (2)

• Composite Renal Outcome

  Doubling of creatinine or dialysis initiation.

  36 months

• Composite Cardiovascular Outcome

  Time to first non-fatal myocardial infarction, non-fatal stroke, hospitalization for heart failure, or cardiovascular death

  36 months

Secondary Outcomes (2)

• Chronic kidney disease progression

  36 months

• Proteinuria progression

  36 months

Interventions

Bioimpedance Spectroscopy DEVICE

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.

Arterial Stiffness DEVICE

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.

Echocardiography DIAGNOSTIC_TEST

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).

Lung ultrasonography DIAGNOSTIC_TEST

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).

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Kidney Transplant Recipients

You may qualify if:

• age\>18 years;
• Kidney Transplant Recipient.

You may not qualify if:

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

Sponsors & Collaborators

• Grigore T. Popa University of Medicine and Pharmacy: lead

Study Sites (1)

"Dr. C.I. Parhon" Hospital

Iași, Romania

RECRUITING

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Echocardiography

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Officials

• Adrian Covic, Prof

  Grigore T. Popa University of Medicine and Pharmacy, Iasi

  STUDY CHAIR

Central Study Contacts

Dimitrie Siriopol

CONTACT

+40740138874; dimitrie.siriopol@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 36 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 8, 2019
• First Posted: June 30, 2020
• Study Start: February 1, 2020
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: June 30, 2020

Record last verified: 2020-06

Locations

RO (1)