LVAD Versus GDMT in Ambulatory Advanced Heart Failure Patients (AMBU-VAD)

May 4, 2026 updated by: Hospices Civils de Lyon

Left Ventricular Assist Device (LVAD) Versus Guideline Recommended Medical Therapy in Ambulatory Advanced Heart Failure Patients (GDMT)

Heart failure is a severe disease affecting approximately 1-2% of the adult population in developed countries and around 26 million people worldwide. Up to 10% of these patients are in advanced stage heart failure, which is defined by a significant morbimortality and considerable medical expenses. Despite advances in its medical management, advanced (or end stage) heart failure is characterized by refractoriness to conventional therapies including guideline-directed pharmacological and non-surgical device treatments. These patients remain severely symptomatic (NYHA IV) and have objective signs of congestion or low cardiac output.

Left ventricular assist devices (LVADs) have been used in patients with heart failure with reduced ejection fraction for almost 20 years either as an alternative or a bridge to heart transplantation. LVADs improve heart failure symptoms and survival at the cost of increased rates of infection, stroke and bleeding.

Despite the lack of evidence, LVAD implantation in ambulatory patients is not rare, with INTERMACS profiles ≥4 patients representing 15.7% of the overall population implanted between 2012 and 2016.

The aim of this study is to investigate the efficacy and safety of left ventricular assist devices compared to traditional HF medical treatment alone in a population of ambulatory advanced heart failure patients. Secondary objectives are to better identify subgroups of patients that would benefit the most from the implantation of an LVAD as well as to assess the optimal timing of intervention.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
92

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Besançon, France
        • Recruiting
        • CHU Besancon
        • Contact:
          • MARIE FRANCE SERONDE, Pr
        • Principal Investigator:
          • MARIE FRANCE SERONDE, Pr
      • Bron, France
        • Recruiting
        • Hôpital Pneumologique et Cardiovasculaire Louis Pradel
        • Contact:
      • Caen, France
        • Recruiting
        • CHU Caen
        • Contact:
          • KATRIEN DR BLANCHART, Dr
        • Principal Investigator:
          • KATRIEN DR BLANCHART, Dr
      • La Tronche, France
        • Recruiting
        • La Tronche Hospital / CHU Grenoble
        • Contact:
        • Principal Investigator:
          • AUDE BOIGNARD, Dr
      • Montpellier, France
      • Rouen, France
        • Recruiting
        • CHU Rouen
        • Principal Investigator:
          • FABRICE BAUER
        • Contact:
          • FABRICE BAUER
      • Tours, France
        • Recruiting
        • CHU Tours
        • Contact:
          • Thierry BOURGUIGNON, Dr
        • Principal Investigator:
          • Thierry BOURGUIGNON
      • Vandœuvre-lès-Nancy, France
        • Recruiting
        • CHRU, Institut Lorrain du Coeur et des Vaisseaux Louis Mathieu
        • Contact:
        • Principal Investigator:
          • GUILLAUME BAUDRY, Dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. All patients ≥18 years,

  2. End-stage heart failure, evaluated by the local Heart Team, defined as:

    • Left ventricular ejection fraction ≤ 35% within 1 week prior to randomization and
    • Cardiac Index < 2.2 L/min/m² by hemodynamic use within 1 month prior to randomization or VO2 max < 14 ml/kg/min (or <50% of predicted VO2max) within 1 month prior to randomization OR low 6-min walking test (< 420 m) within 1 month prior to randomization or ≥ 2 hospitalizations for heart failure in the past year and
    • NYHA III-IV (INTERMACS profile 4-6) and and
    • Receiving medical management with optimal doses of betablockers, Angiotensin-Converting-Enzyme-inhibitors or Angiotensin II Receptor Blockers or angiotensin receptor neprilysin inhibitor (if eligible) and Mineralocorticoid Receptor Antagonists and Sodium-GLucose co-Transporter-2 (SGLT2) inhibitors for at least 45 days if tolerated according to guideline at maximal tolerated dose (if maximal HF drug dosage is not reached the investigators will have to explain reason behind not maximal dosage).
    • Receiving Cardiac Resynchronization Therapy and or Implantable Cardioverter Defibrillators if indicated for at least 45 days and
    • No mechanical circulatory support or inotrope therapy since > 30 days,
  3. Having a health coverage,
  4. Signed written informed consent,
  5. Patient without any legal protection measure.

Exclusion Criteria:

  1. Inotrope dependent patients or existence of ongoing mechanical circulatory support (MCS) in the last 30 days,
  2. Right ventricular dysfunction (heart team consensus) with the expected need of Bi-VAD support,
  3. Female patients currently pregnant or women of childbearing age who were not using contraception,
  4. Active infection,
  5. Irreversible end-organ dysfunction prior to LVAD implantation,
  6. Contraindication to anti-coagulant or anti-platelet therapies,
  7. History of any organ transplant prior to inclusion,
  8. Psychiatric disease/disorder, irreversible cognitive dysfunction or psychosocial issues likely to impair compliance,
  9. Frailty according to heart team,
  10. Platelet count < 100,000 x 103/liter (<100,000/ml)
  11. Body Surface Area (BSA) < 1.2 m2,
  12. Any condition other than heart failure that could limit survival to less than 24 months,
  13. Chronic renal insufficiency (GFR definitely <30 ml/min) or hepatic cirrhosis,
  14. Participation in any other interventional clinical investigation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Early Left Ventricular Assist Device and Guideline Directed Medical Therapy
The intervention group will receive an early left ventricular assist device implantation (bridge to transplantation, bridge to candidacy or destination therapy) in addition to guideline directed medical therapy within 21 days of randomization.
Device: HeartMate 3 TM Left Ventricular Assist System
The HeartMate 3 TM Left Ventricular Assist System will be implanted within 21 days of randomization.
Other: Guideline Directed Medical Therapy
Patients randomized in the control group will continue their guideline directed medical therapy which comprises the following stable combination at the maximal tolerated dose of betablockers, Angiotensin-Converting-Enzyme-inhibitors or Angiotensin II Receptor Blockers or Angiotensin receptor Neprilysin inhibitor and Mineralocorticoid Receptor Antagonists and Sodium-GLucose co-Transporter-2 (SGLT2) inhibitors if tolerated.
Other: Guideline Directed Medical Therapy
Patients randomized in the control group will continue their guideline directed medical therapy which comprises the following stable combination at the maximal tolerated dose of betablockers, Angiotensin-Converting-Enzyme-inhibitors or Angiotensin II Receptor Blockers or Angiotensin receptor Neprilysin inhibitor and Mineralocorticoid Receptor Antagonists and Sodium-GLucose co-Transporter-2 (SGLT2) inhibitors if tolerated.
Other: Guideline Directed Medical Therapy
Patients randomized in the control group will continue their guideline directed medical therapy which comprises the following stable combination at the maximal tolerated dose of betablockers, Angiotensin-Converting-Enzyme-inhibitors or Angiotensin II Receptor Blockers or Angiotensin receptor Neprilysin inhibitor and Mineralocorticoid Receptor Antagonists and Sodium-GLucose co-Transporter-2 (SGLT2) inhibitors if tolerated.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
All-cause mortality rate
Time Frame: Through 24 months when the last subject completes 12 months of follow-up
The composite of 5 clinical endpoints is using a win ratio concept. Mortality has higher priority than Urgent ECMO implantation, urgent heart transplantation or LVAD implantation, unplanned hospitalization for heart failure, improvement of KCCQ by at least 5points, improvement of 6-minute walk test distance by at least 75 meters. Our main approach uses matched pairs of patients. Each pair is 'untied' first on the basis of the most important event (death) and secondly (if necessary) on the lesser event. The numbers of pairs in which the patient on new treatment 'won' and 'lost' are compared to produce the 'win ratio'. The 95% CI and P-value for the win ratio are readily obtained.
Through 24 months when the last subject completes 12 months of follow-up
Number of urgent ECMO implantation
Time Frame: Through 24 months when the last subject completes 12 months of follow-up
The composite of 5 clinical endpoints is using a win ratio concept. Mortality has higher priority than Urgent ECMO implantation, urgent heart transplantation or LVAD implantation, unplanned hospitalization for heart failure, improvement of KCCQ by at least 5points, improvement of 6-minute walk test distance by at least 75 meters. Our main approach uses matched pairs of patients. Each pair is 'untied' first on the basis of the most important event (death) and secondly (if necessary) on the lesser event. The numbers of pairs in which the patient on new treatment 'won' and 'lost' are compared to produce the 'win ratio'. The 95% CI and P-value for the win ratio are readily obtained.
Through 24 months when the last subject completes 12 months of follow-up
Number of urgent heart transplantation
Time Frame: Through 24 months when the last subject completes 12 months of follow-up
The composite of 5 clinical endpoints is using a win ratio concept. Mortality has higher priority than Urgent ECMO implantation, urgent heart transplantation or LVAD implantation, unplanned hospitalization for heart failure, improvement of KCCQ by at least 5points, improvement of 6-minute walk test distance by at least 75 meters. Our main approach uses matched pairs of patients. Each pair is 'untied' first on the basis of the most important event (death) and secondly (if necessary) on the lesser event. The numbers of pairs in which the patient on new treatment 'won' and 'lost' are compared to produce the 'win ratio'. The 95% CI and P-value for the win ratio are readily obtained.
Through 24 months when the last subject completes 12 months of follow-up
Number of LVAD implantation
Time Frame: Through 24 months when the last subject completes 12 months of follow-up
The composite of 5 clinical endpoints is using a win ratio concept. Mortality has higher priority than Urgent ECMO implantation, urgent heart transplantation or LVAD implantation, unplanned hospitalization for heart failure, improvement of KCCQ by at least 5points, improvement of 6-minute walk test distance by at least 75 meters. Our main approach uses matched pairs of patients. Each pair is 'untied' first on the basis of the most important event (death) and secondly (if necessary) on the lesser event. The numbers of pairs in which the patient on new treatment 'won' and 'lost' are compared to produce the 'win ratio'. The 95% CI and P-value for the win ratio are readily obtained.
Through 24 months when the last subject completes 12 months of follow-up
Number of unplanned hospitalization for heart failure
Time Frame: Through 24 months when the last subject completes 12 months of follow-up
The composite of 5 clinical endpoints is using a win ratio concept. Mortality has higher priority than Urgent ECMO implantation, urgent heart transplantation or LVAD implantation, unplanned hospitalization for heart failure, improvement of KCCQ by at least 5points, improvement of 6-minute walk test distance by at least 75 meters. Our main approach uses matched pairs of patients. Each pair is 'untied' first on the basis of the most important event (death) and secondly (if necessary) on the lesser event. The numbers of pairs in which the patient on new treatment 'won' and 'lost' are compared to produce the 'win ratio'. The 95% CI and P-value for the win ratio are readily obtained.
Through 24 months when the last subject completes 12 months of follow-up
Quality of life assessed by KCCQ score
Time Frame: Through 24 months when the last subject completes 12 months of follow-up
The composite of 5 clinical endpoints is using a win ratio concept. Mortality has higher priority than Urgent ECMO implantation, urgent heart transplantation or LVAD implantation, unplanned hospitalization for heart failure, improvement of KCCQ by at least 5points, improvement of 6-minute walk test distance by at least 75 meters. Our main approach uses matched pairs of patients. Each pair is 'untied' first on the basis of the most important event (death) and secondly (if necessary) on the lesser event. The numbers of pairs in which the patient on new treatment 'won' and 'lost' are compared to produce the 'win ratio'. The 95% CI and P-value for the win ratio are readily obtained.
Through 24 months when the last subject completes 12 months of follow-up
Distance in meters at 6-min walking test
Time Frame: Through 24 months when the last subject completes 12 months of follow-up
The composite of 5 clinical endpoints is using a win ratio concept. Mortality has higher priority than Urgent ECMO implantation, urgent heart transplantation or LVAD implantation, unplanned hospitalization for heart failure, improvement of KCCQ by at least 5points, improvement of 6-minute walk test distance by at least 75 meters. Our main approach uses matched pairs of patients. Each pair is 'untied' first on the basis of the most important event (death) and secondly (if necessary) on the lesser event. The numbers of pairs in which the patient on new treatment 'won' and 'lost' are compared to produce the 'win ratio'. The 95% CI and P-value for the win ratio are readily obtained.
Through 24 months when the last subject completes 12 months of follow-up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of adverse events (AEs)
Time Frame: at 1 month
at 1 month
Number of adverse events (AEs)
Time Frame: at 3 months
at 3 months
Number of adverse events (AEs)
Time Frame: at 6 months
at 6 months
Number of adverse events (AEs)
Time Frame: at 12 months
at 12 months
Number of adverse events (AEs)
Time Frame: at 18 months
at 18 months
Number of adverse events (AEs)
Time Frame: at 24 months
at 24 months
All-cause mortality rate
Time Frame: at 1 month
at 1 month
All-cause mortality rate
Time Frame: at 3 months
at 3 months
All-cause mortality rate
Time Frame: at 6 months
at 6 months
All-cause mortality rate
Time Frame: at 12 months
at 12 months
All-cause mortality rate
Time Frame: at 18 months
at 18 months
All-cause mortality rate
Time Frame: at 24 months
at 24 months
number of ECMO implantation
Time Frame: at 1 month
at 1 month
number of ECMO implantation
Time Frame: at 3 months
at 3 months
number of ECMO implantation
Time Frame: at 6 months
at 6 months
number of ECMO implantation
Time Frame: at 12 months
at 12 months
number of ECMO implantation
Time Frame: at 18 months
at 18 months
number of ECMO implantation
Time Frame: at 24 months
at 24 months
number of urgent heart transplantation
Time Frame: at 1 month
at 1 month
number of urgent heart transplantation
Time Frame: at 3 months
at 3 months
number of urgent heart transplantation
Time Frame: at 12 months
at 12 months
number of urgent heart transplantation
Time Frame: at 18 months
at 18 months
number of urgent heart transplantation
Time Frame: at 24 months
at 24 months
VAD implantation rate
Time Frame: at 1 month
at 1 month
VAD implantation rate
Time Frame: at 3 months
at 3 months
VAD implantation rate
Time Frame: at 6 months
at 6 months
VAD implantation rate
Time Frame: at 12 months
at 12 months
VAD implantation rate
Time Frame: at 18 months
at 18 months
VAD implantation rate
Time Frame: at 24 months
at 24 months
Unplanned hospitalization for heart failure rate
Time Frame: at 1 month
at 1 month
Unplanned hospitalization for heart failure rate
Time Frame: at 3 months
at 3 months
Unplanned hospitalization for heart failure rate
Time Frame: at 6 months
at 6 months
Unplanned hospitalization for heart failure rate
Time Frame: at 12 months
at 12 months
Unplanned hospitalization for heart failure rate
Time Frame: at 18 months
at 18 months
Unplanned hospitalization for heart failure rate
Time Frame: at 24 months
at 24 months
Recurrent hospitalizations rate
Time Frame: at 1 month
Defined as total number of hospitalizations
at 1 month
Recurrent hospitalizations rate
Time Frame: at 3 months
Defined as total number of hospitalizations
at 3 months
Recurrent hospitalizations rate
Time Frame: at 6 months
Defined as total number of hospitalizations
at 6 months
Recurrent hospitalizations rate
Time Frame: at 12 months
Defined as total number of hospitalizations
at 12 months
Recurrent hospitalizations rate
Time Frame: at 18 months
Defined as total number of hospitalizations
at 18 months
Recurrent hospitalizations rate
Time Frame: at 24 months
Defined as total number of hospitalizations
at 24 months
Number of patients with a persistence of the eligibility to LVAD implantation
Time Frame: at 12 and 24 months
In the GDMT group only
at 12 and 24 months
Number of patients with a persistence of the eligibility to LVAD implantation
Time Frame: at 12 months
In the GDMT group only
at 12 months
Number of days alive out of hospital
Time Frame: at 24 months
at 24 months
New York Heart Association (NYHA) status
Time Frame: at inclusion
at inclusion
New York Heart Association (NYHA) status
Time Frame: at 1 month
at 1 month
New York Heart Association (NYHA) status
Time Frame: at 3 months
at 3 months
New York Heart Association (NYHA) status
Time Frame: at 6 months
at 6 months
New York Heart Association (NYHA) status
Time Frame: at 12 months
at 12 months
New York Heart Association (NYHA) status
Time Frame: at 18 months
at 18 months
New York Heart Association (NYHA) status
Time Frame: at 24 months
at 24 months
Distance in meters at 6-min walking test
Time Frame: at inclusion
at inclusion
Distance in meters at 6-min walking test
Time Frame: at 3 months
at 3 months
Distance in meters at 6-min walking test
Time Frame: at 6 months
at 6 months
Distance in meters at 6-min walking test
Time Frame: at 12 months
at 12 months
Distance in meters at 6-min walking test
Time Frame: at 18 months
at 18 months
Distance in meters at 6-min walking test
Time Frame: at 24 months
at 24 months
Quality of life assessed by European Quality of Life-5 Dimensions (EQ-5D) questionnaire score
Time Frame: at inclusion
at inclusion
Quality of life assessed by European Quality of Life-5 Dimensions (EQ-5D) questionnaire score
Time Frame: at 3 months
at 3 months
Quality of life assessed by European Quality of Life-5 Dimensions (EQ-5D) questionnaire score
Time Frame: at 6 months
at 6 months
Quality of life assessed by European Quality of Life-5 Dimensions (EQ-5D) questionnaire score
Time Frame: at 12 months
at 12 months
Quality of life assessed by European Quality of Life-5 Dimensions (EQ-5D) questionnaire score
Time Frame: at 18 months
at 18 months
Quality of life assessed by European Quality of Life-5 Dimensions (EQ-5D) questionnaire score
Time Frame: at 24 months
at 24 months
Quality of life assessed by KCCQ score
Time Frame: at inclusion
at inclusion
Quality of life assessed by KCCQ score
Time Frame: at 3 months
at 3 months
Quality of life assessed by KCCQ score
Time Frame: at 6 months
at 6 months
Quality of life assessed by KCCQ score
Time Frame: at 12 months
at 12 months
Quality of life assessed by KCCQ score
Time Frame: at 18 months
at 18 months
Quality of life assessed by KCCQ score
Time Frame: at 24 months
at 24 months
Right ventricular function assessed by echocardiographic parameters
Time Frame: at inclusion
at inclusion
Right ventricular function assessed by echocardiographic parameters
Time Frame: at 3 months
at 3 months
Right ventricular function assessed by echocardiographic parameters
Time Frame: at 6 months
at 6 months
Right ventricular function assessed by echocardiographic parameters
Time Frame: at 12 months
at 12 months
Right ventricular function assessed by echocardiographic parameters
Time Frame: at 18 months
at 18 months
Right ventricular function assessed by echocardiographic parameters
Time Frame: at 24 months
at 24 months
Heart failure assessed by N Terminal Pro-Brain Natriuretic Peptide (NT-proBNP) rate
Time Frame: at inclusion
at inclusion
Heart failure assessed by N Terminal Pro-Brain Natriuretic Peptide (NT-proBNP) rate
Time Frame: at 3 months
at 3 months
Heart failure assessed by N Terminal Pro-Brain Natriuretic Peptide (NT-proBNP) rate
Time Frame: at 6 months
at 6 months
Heart failure assessed by N Terminal Pro-Brain Natriuretic Peptide (NT-proBNP) rate
Time Frame: at 12 months
at 12 months
Heart failure assessed by N Terminal Pro-Brain Natriuretic Peptide (NT-proBNP) rate
Time Frame: at 18 months
at 18 months
Heart failure assessed by N Terminal Pro-Brain Natriuretic Peptide (NT-proBNP) rate
Time Frame: at 24 months
at 24 months
Cardio-renal syndrome assessed by rates of Soluble urokinase-type Plasminogen Activator Receptor (SuPAR)
Time Frame: at inclusion
at inclusion
Cardio-renal syndrome assessed by rates of Soluble urokinase-type Plasminogen Activator Receptor (SuPAR)
Time Frame: at 1 month
at 1 month
Cardio-renal syndrome assessed by rates of Soluble urokinase-type Plasminogen Activator Receptor (SuPAR)
Time Frame: at 6 months
at 6 months
Cardio-renal syndrome assessed by rates of Soluble urokinase-type Plasminogen Activator Receptor (SuPAR)
Time Frame: at 12 months
at 12 months
Cardio-renal syndrome assessed by rates of Soluble urokinase-type Plasminogen Activator Receptor (SuPAR)
Time Frame: at 24 months
at 24 months
Cardio-renal syndrome assessed by rates of Interleukin-6 (IL-6)
Time Frame: at inclusion
at inclusion
Cardio-renal syndrome assessed by rates of Interleukin-6 (IL-6)
Time Frame: at 1 month
at 1 month
Cardio-renal syndrome assessed by rates of Interleukin-6 (IL-6)
Time Frame: at 6 months
at 6 months
Cardio-renal syndrome assessed by rates of Interleukin-6 (IL-6)
Time Frame: at 12 months
at 12 months
Cardio-renal syndrome assessed by rates of Interleukin-6 (IL-6)
Time Frame: at 24 months
at 24 months
Cardio-renal syndrome assessed by rates of Kidney Injury Molecule-1 (KIM1)
Time Frame: at inclusion
at inclusion
Cardio-renal syndrome assessed by rates of Kidney Injury Molecule-1 (KIM1)
Time Frame: at 1 month
at 1 month
Cardio-renal syndrome assessed by rates of Kidney Injury Molecule-1 (KIM1)
Time Frame: at 3 months
at 3 months
Cardio-renal syndrome assessed by rates of Kidney Injury Molecule-1 (KIM1)
Time Frame: at 12 months
at 12 months
Cardio-renal syndrome assessed by rates of Kidney Injury Molecule-1 (KIM1)
Time Frame: at 18 months
at 18 months
Cardio-renal syndrome assessed by rates of Kidney Injury Molecule-1 (KIM1)
Time Frame: at 24 months
at 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospices Civils de Lyon

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Guillaume BAUDRY, Dr, CHRU Nancy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 24, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 17, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 22, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 24, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 69HCL20_0072
  • ID-RCB (Other Identifier: 2025-A02239-40)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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