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Kidney Transplant; ComplicationsROKET-CVNCT04451356

Romanian Kidney Transplant Cardiovascular Risk Registry

An observational study of Kidney Transplant; Complications and Cardiovascular Diseases, run by Grigore T. Popa University of Medicine and Pharmacy at 1 site in Romania.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Bioimpedance Spectroscopy, Arterial Stiffness and Echocardiography
Type of treatment
Medical device
How many people
300 participants
Where
1 siteRomania
Study dates
1 Feb 2020to Dec 2022
How long will I take part?
36 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Kidney Transplant Recipients

Who may be able to join

  • age>18 years;
  • Kidney Transplant Recipient.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Romania1 site, 1 recruiting
  • "Dr. C.I. Parhon" Hospital

    Iași

    Dimitrie Siriopol

    Recruiting

Other trials in Romania

About this study

Official title: The Complex Evaluation of the Cardiovascular Risk in the Kidney Transplant Patients

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.

Read the detailed description
  • Patients:

The inclusion criteria are:

  1. age>18 years;
  2. KT recipient.

The exclusion criteria are:

  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.
  • Methods:

All patients will have a complete clinical and paraclinical evaluation:

  • Personal data (age, sex, height);
  • Cardiovascular risk factors (smoking, weight, body mass index);
  • Medication (including immunosupression);
  • Kidney transplantation data (date of transplantation, type - living or cadaveric donor, missmatch number, type of induction therapy);
  • Dialysis vintage (before KT)
  • Comorbidities (diabetes, hypertension, stroke, coronary artery disease, etc);
  • Physical examination (blood pressure, crackles, pedal edema etc);
  • Renal function evaluation (serum urea and creatinine, serum electrolytes - K, Na, Cl)
  • Nutrition status evaluation: serum protein, cholesterol, triglycerides;
  • Inflammation evaluation: CRP;
  • Serum glucose and uric acid;
  • Hemoleucogram;
  • Electrocardiogram.

Bioimpedance spectroscopy analysis 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. Absolute fluid overload (AFO) is is defined as the difference between the expected patient's ECW under normal physiological conditions and the actual ECW, whereas the relative fluid overload (RFO) is defined as the absolute fluid overload AFO to ECW ratio. Normohydration is defined when AFO is between the 10th and the 90th percentile for healthy, age- and gender-matched individuals from the reference population, i.e. between -1.1 to +1.1 L, while volumes below and above this range defining underhydration and overhydration, respectively. In addition, this analysis will provide the LTI and FTI for the included patients.

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).

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).

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. The SphygmoCor PWV has been established in the literature as a reference for comparison due to the wealth of population data and healthy population refence values. The investigators will determine two PWVs for every patient and use the media for the statistical analysis. If the difference between these two measurements will be higher than 0.5 m/s then another determination will be performed and the median will be used for analysis.

Being tested
Bioimpedance Spectroscopy, Arterial Stiffness, Echocardiography, Lung ultrasonography
Keywords
Kidney Transplant, Bioimpedance Spectroscopy, Arterial stiffness
Medical subject headings
Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bioimpedance SpectroscopyDevice

    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 StiffnessDevice

    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.

  • EchocardiographyDiagnostic 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 ultrasonographyDiagnostic 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).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Composite Renal Outcome

    Doubling of creatinine or dialysis initiation.

    Measured: 36 months

  2. Composite Cardiovascular Outcome

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

    Measured: 36 months

Secondary outcomes (2)
  1. Chronic kidney disease progression

    The impact of baseline characteristics on eGFR (as assessed by the CKD-EPI formula) evolution

    Measured: 36 months

  2. Proteinuria progression

    The impact of baseline characteristics on proteinuria (as assessed by the urine protein to creatinine ratio) evolution

    Measured: 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jun 2020
  2. Study start1 Feb 2020
  3. Primary completionDec 2022 (estimated)
  4. Study completionDec 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
300 participants (estimated)
Target duration
36 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT04451356
Sponsor's protocol ID
UMF
Acronym
ROKET-CV
Status last verified
Jun 2020
First submitted
8 Oct 2019
Last updated
30 Jun 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Kidney Transplant; Complications and Cardiovascular Diseases, run by Grigore T. Popa University of Medicine and Pharmacy at 1 site in Romania.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 30 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Dimitrie Siriopol (+40740138874, dimitrie.siriopol@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite Renal Outcome (time frame: 36 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2020.

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