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Lung Water by Ultrasound Guided Treatment in Hemodialysis Patients (The Lust Study). (LUST)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02310061
Recruitment Status : Unknown
Verified September 2016 by Carmine Zoccali, Istituto di Fisiologia Clinica CNR.
Recruitment status was:  Recruiting
First Posted : December 5, 2014
Last Update Posted : September 9, 2016
Sponsor:
Collaborators:
Manhes Hospital, Fleury Mérogis
Saarland University
Centre Hospitalier Universitaire, Amiens
Renal Unit, University of Madrid
Universitatea de Medicina si Farmacie Iasi
Medical University of Silesia
Hospital Universitari de Bellvitge
Akdeniz University
King's College London
Central Hospital, Nancy, France
ALTIR Nancy
University Hospital, Strasbourg
Shaare Zedek Medical Center
University Medical Centre Maribor
IASIO Hospital – General Clinic of Kallithea
ASL Parma
University Hospital, Ioannina
Hannover Medical School
Wroclaw Medical University
C.T.M.R. Saint-Augustin
Hospital Ambroise Paré Paris
Centre Hospitalier F.H. Manhès
Azienda USL 12 Versilia
Aristotle University Of Thessaloniki
Information provided by (Responsible Party):
Carmine Zoccali, Istituto di Fisiologia Clinica CNR

Brief Summary:

Volume overload is a leading risk factor for death and cardiovascular events in end stage renal disease patients maintained on chronic dialysis, particularly in those with myocardial ischemia and heart failure which represent a substantial fraction of this population. Early identification of volume overload may prevent cardiovascular sequel in these patients but clinical signs of volume expansion are unsatisfactory to reliably identify patients at risk and to monitor them over time. On the other hand, however reliable, standard techniques for measuring extracellular or circulating (blood) volume do not convey information on fundamental heart function parameters that determine the individual haemodynamic tolerance to volume excess and the response to ultrafiltration, i.e. left ventricular (LV) filling pressure and LV function.

Extra-vascular lung water is critically dependent on these parameters and represents a proxy of both, circulating volume and LV filling pressure and function, and may therefore be a better criterion to identify patients at a higher risk of volume-dependent adverse clinical outcomes and to monitor the effect of therapy aimed at preventing these outcomes. A fast (< 5 min.), easy to learn, simple and non-expensive technique which measures extra-vascular lung water by using standard ultrasound (US) machines has been validated in dialysis patients. Whether systematic measurement of lung water by this technique may translate into better clinical outcomes in End Stage Renal Disease (ESRD) patients has never been tested.

The aim of this randomized clinical trial is that of testing a treatment policy guided by extra-vascular lung water measurements by ultrasound to prevent death, decompensated heart failure and myocardial infarction as well as progression of Left Ventricular Hypertrophy (LVH) and LV dysfunction and hospitalization in high risk dialysis patients with myocardial ischemia (a history of myocardial infarction with or without ST elevation or unstable angina, acute coronary syndrome documented by ECG recordings and cardiac troponins or stable angina pectoris with documented coronary artery disease by prior coronary angiography or ECG) or overt heart failure (NYHA class III-IV).


Condition or disease Intervention/treatment Phase
Kidney Failure, Chronic Procedure: Extra-vascular lung water measurements by ultrasound (LW-US) Other: Standard protocol of fluid management in hemodialysis Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Lung Water By Ultra-Sound Guided Treatment To Prevent Death and Cardiovascular Complications in High Risk End Stage Renal Disease Patients With Cardiomyopathy (Lust Study)
Study Start Date : November 2013
Estimated Primary Completion Date : November 2016
Estimated Study Completion Date : May 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Control arm
Standard protocol of fluid management in hemodialysis
Other: Standard protocol of fluid management in hemodialysis
The intervention consists in applying a standard clinical approach for monitoring/tailoring fluid excess in HD patients.

Experimental: Active arm
Extra-vascular lung water measurements by ultrasound (LW-US)
Procedure: Extra-vascular lung water measurements by ultrasound (LW-US)
It is widely agreed that the high prevalence of patients with LV dysfunction and heart failure and the lack of simple, non-expensive, bedside techniques that may serve to estimate and monitor parameters of central hemodynamics for guiding the prescription of ultrafiltration (UF) and drug treatment is a factor of major clinical relevance. So,in patients allocated to the active arm, nephrologists register pre- and post-dialysis US-B lines whenever considered useful for volume monitoring.
Other Name: LW-US




Primary Outcome Measures :
  1. Cumulative incidence of the composite outcome "death, myocardial infarction, heart failure". [ Time Frame: All events occurred during 24 months of follow up will be assessed at 1 year and 2 years after the start of the study. For Time-to-Event analyses, we will consider the time from the first visit to the first occurrence of death, or MI or heart failure. ]

    Myocardial infarction and heart failure will be defined on the basis of international standard protocols.

    - The following figures we expect to occur in the two study arms:

    Active arm: 30% Control arm: 45%


  2. All-cause and cardiovascular hospitalization. [ Time Frame: All events occurred during 24 months of follow up will be assessed at 1 year and 2 years after the start of the study. For Time-to-Event analyses, we will consider the time from the first visit to the first occurrence of all-cause and CV hospitalization ]

    Hospitalization will be characterized on the basis of ICD9 codes.

    - The following figures we expect to occur in the two study arms:

    Active arm: 1.00 hospitalization/patientyear Control arm: 1.50 hospitalization/patientyear


  3. Left atrial volume [ Time Frame: Left atrial volume (LAV) will be measured by cardiologists at baseline, 6, 12 and 24 months ]

    Left atrial volume will be measured by Echocardiography.

    We expect the following changes in LAV between the two study arms:

    Active arm: -2±17 Control arm: 4±17


  4. Diastolic function. [ Time Frame: Diastolic function (E/E') will be measured by cardiologists at baseline, 6, 12 and 24 months ]

    Diastolic function will be assessed by Echocardiography.

    We expect the following changes in E/E' between the two study arms:

    Active arm: -2±6 Control arm: 0±6


  5. Left ventricular mass index (LVMI) [ Time Frame: LVMI will be measured by cardiologists at baseline, 6, 12 and 24 months ]

    LVMI will be measured by Echocardiography.

    We expect the following changes in LVMI between the two study arms:

    Active arm: - 2±11 Control arm: 3±11


  6. Left ventricular ejection fraction (LVEF) [ Time Frame: LVEF will be measured by cardiologists at baseline, 6, 12 and 24 months ]

    Left ventricular ejection fraction will be measured by Echocardiography.

    We expect the following changes in LVEF between the two study arms:

    Active arm: 3±9% Control arm: 0±9%




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
Criteria

Inclusion Criteria:

  • Age > 18 years
  • Dialysis vintage > 3 months
  • A history of myocardial infarction with or without ST elevation or unstable angina, acute coronary syndrome, documented by ECG recordings and cardiac troponins, or stable angina pectoris with documented coronary artery disease by prior coronary angiography or ECG or dyspnoea class III-IV NYHA
  • Written consent to take part in the study

Exclusion Criteria:

  • Cancer or other advanced non cardiac disease or comorbidity (e.g. end-stage liver failure) imposing a very poor short-term prognosis
  • Active infections or relevant inter-current disease
  • Inadequate lung scanning and echocardiographic studies

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): NCT02310061


Contacts
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Contact: Carmine Zoccali, Prof 0965 397002 carmine.zoccali@tin.it

Locations
Show Show 25 study locations
Sponsors and Collaborators
Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
Manhes Hospital, Fleury Mérogis
Saarland University
Centre Hospitalier Universitaire, Amiens
Renal Unit, University of Madrid
Universitatea de Medicina si Farmacie Iasi
Medical University of Silesia
Hospital Universitari de Bellvitge
Akdeniz University
King's College London
Central Hospital, Nancy, France
ALTIR Nancy
University Hospital, Strasbourg
Shaare Zedek Medical Center
University Medical Centre Maribor
IASIO Hospital – General Clinic of Kallithea
ASL Parma
University Hospital, Ioannina
Hannover Medical School
Wroclaw Medical University
C.T.M.R. Saint-Augustin
Hospital Ambroise Paré Paris
Centre Hospitalier F.H. Manhès
Azienda USL 12 Versilia
Aristotle University Of Thessaloniki
Investigators
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Principal Investigator: Carmine Zoccali, Prof CNR-IBIM and Nephrology Unit, Reggio Calabria
Publications:

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Responsible Party: Carmine Zoccali, MD, FASN, Professor of Nephrology (PG), Istituto di Fisiologia Clinica CNR
ClinicalTrials.gov Identifier: NCT02310061    
Other Study ID Numbers: ERA-EDTA-01062012
First Posted: December 5, 2014    Key Record Dates
Last Update Posted: September 9, 2016
Last Verified: September 2016
Keywords provided by Carmine Zoccali, Istituto di Fisiologia Clinica CNR:
Dialysis
ESRD
lung congestion
heart failure
LW-US
Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic