Tolerability and Safety of CARDIOMEMS™ Intracardiac Continuous Cardiac Hemodynamic Monitoring Device in Patients with Cardio Renal Syndrome with Severe Renal Impairment

Official title

Evaluation of the Tolerability and Safety of the CARDIOMEMS™ Intracardiac Continuous Cardiac Hemodynamic Monitoring Device in Patients with Cardio Renal Syndrome with Severe Renal Impairment

Overview

Renal failure is present in 40% of heart failure patients, and is one of the main comorbidities of heart failure. Follow-up with pulmonary artery pressure (PAP) monitoring has shown a reduction in mortality and frequency of hospitalization in patients with heart failure alone in the CHAMPION trial. Patients with New York Heart Association class III heart failure and a hospitalization in the previous 12 months were included in that study. They benefited from the "CardioMEMS™ HF" device with a sensor implanted in the pulmonary artery to measure PAP. According to that study, the information led to more precise and early adaptation of therapy by avoiding the onset of heart failure symptoms and reducing the number of hospitalizations. However, in that study, patients with impaired renal function (Glomerular Filtration Rate\<25 mL/min/1.73m2) were excluded, limiting the indication for treatment in those patients, and the evolution of renal function during the study was not reported. Patients with heart failure AND advanced renal failure are defined as having a cardio-renal syndrome, with strong interaction between these 2 organs. In the event of predominant right heart failure, they may require treatment by renal replacement or dialysis. There seems to be a link between high venous pressure, renal repercussions and the need for dialysis. Additional follow-up data in this clinical situation are needed to confirm this link and to suggest the interest of continuous PAP monitoring to improve the management of these patients with cardio-renal syndrome with severe renal impairment defined by a Glomerular Filtration Rate\< 30 ml/min/1.73m2 (KDIGO Cardio-renal 2019). This pilot study aims to evaluate how tolerable the "CARDIOMEMS™ HF" device in patients with cardio-renal syndrome and obtain the first information on the relationship between cardiac hemodynamics and renal function in this population.

Detailed description

There are currently 1.5 million heart failure patients in France. The high morbidity and mortality make it a major public health issue. Renal failure, present in 40% of these patients, is one of the main comorbidities of heart failure and makes its management more complex. Medical follow-up with pulmonary artery pressure (PAP) monitoring has shown a reduction in mortality and frequency of hospitalization in patients with heart failure alone in the CHAMPION trial. Patients with New York Heart Association class III heart failure and a hospitalization in the previous 12 months were included in this study. They benefited from the "CardioMEMS™ HF" device with implantation of a sensor in the pulmonary artery allowing direct and continuous measurement of PAP. According to this study, this information allowed for more precise and early adaptation of therapy by avoiding the occurrence of heart failure symptoms and reducing the frequency of hospitalizations. In this study, patients with impaired renal function were excluded (Glomerular Filtration Rate \<25 mL/min/1.73m2), limiting the indication for treatment in these patients, and the evolution of renal function during the study was not reported.

Patients with heart failure associated with advanced renal failure are defined as having a cardio-renal syndrome, with a strong interaction between these 2 organs that may, in particular in the case of predominant right heart failure, require treatment by renal replacement or dialysis. According to the data available to date, the predominant hypothesis is a link between high venous pressure, renal repercussions and the need for dialysis. Additional follow-up data in this clinical situation are needed to confirm this link and to suggest the interest of continuous monitoring of PAP to improve the management of these patients with cardio-renal syndrome with severe renal impairment defined by a Glomerular Filtration Rate\< 30 ml/min/1.73m2 (KDIGO Cardio-renal 2019). Therefore, the investigators wish to initiate a pilot study evaluating the tolerability of the "CARDIOMEMS™ HF" device in patients with cardio renal syndrome and obtain the first information on the relationship between cardiac hemodynamics and renal function in this population.

This is the first pilot study on the safety and tolerability of the use of the CardioMEMS™ HF medical device in cardio renal syndrome with severe renal impairment (documented by Glomerular Filtration Rate \< 30 mL/min/1.73m2 measured by Iohexol clearance) treated medically and without renal replacement therapy.

In this study, the CARDIOMEMS™ HF device, the most successful implanted pulmonary arterial pressure monitoring system currently available on the market will be implemented. Its teletransmitted information can guide the treatment of patients with heart failure.This system, by responding to the recent international recommendations which advocate a better understanding of the hemodynamic situation in this pathology with in particular the link between pulmonary arterial pressure and renal function, could help us to identify innovative evaluation tools with a view to improving therapeutic management with the new treatments available in heart failure (AA House et al: HF in kidney disease: a KDIGO conference report).

Interventions

• Device Implantation of the CARDIOMEMS™ HF device
  The initial routine workup includes a nephrological evaluation: mGFR with Iohexol before fitting the CARDIOMEMS™ HF device, renal echo-Doppler, urinary sedimentation, etiological assessment of severe Chronic Kidney Disease, NT-ProBNP, impedancemetry, urinary ionogram, weight, anemia assessment, and correction of possible iron and/or vitamin deficiency and a cardiology evaluation: blood pressure, heart rate, clinical data, biology (Complete Blood Count, iono, urea, creatinine, total bilirubin, fe

Primary outcome measures

• Adverse events [Time frame: On the day of implanting the Cardiomems device]
• Adverse events [Time frame: One month after implanting the Cardiomems device]
• Adverse events [Time frame: Two months after implanting the Cardiomems device]
• Adverse events [Time frame: Three months after implanting the Cardiomems device]
• Adverse events [Time frame: Four months after implanting the Cardiomems device]
• Adverse events [Time frame: Five months after implanting the Cardiomems device]
• Adverse events [Time frame: Six months after implanting the Cardiomems device]
• Adverse events [Time frame: Seven months after implanting the Cardiomems device]
• Adverse events [Time frame: Eight months after implanting the Cardiomems device]
• Adverse events [Time frame: Nine months after implanting the Cardiomems device]

Secondary outcome measures (12)

• Estimated effect on renal function [Time frame: Between 1 day to 1 month before implanting the device.]
• Measured effect on renal function [Time frame: Between 1 day to 1 month before implanting the device.]
• Estimated effect on renal function [Time frame: Day 0 (day of implanting the device)]
• Measured effect on renal function [Time frame: Day 0 (day of implanting the device)]
• Estimated effect on renal function [Time frame: Month 3]
• Measured effect on renal function [Time frame: Month 3]
• Estimated effect on renal function [Time frame: Month 6]
• Measured effect on renal function [Time frame: Month 6]
• Estimated effect on renal function [Time frame: Month 9]
• Measured effect on renal function [Time frame: Month 9]
• Estimated effect on renal function [Time frame: Month 12]
• Measured effect on renal function [Time frame: Month 12]

Eligibility criteria

Inclusion criteria

• Patient with class NYHA III heart failure having been hospitalized in the previous 12 months for cardiac decompensation (the current indication for the CARDIOMEMS™ system), right heart failure or biventricular heart failure with the definition of TAPSE<15mm and/or SDTI<9.5cm/s regardless of LVEF, NtproBNP>1500 pg/ml.
• Patient with advanced renal failure with GFR (CKD-EPI) < 30 ml/min/1.73m2 for more than 3 months confirmed by GFR measurement (Iohexol clearance)
• Patient with a pulmonary artery greater than 7 mm in diameter.
• The patient has been informed of the study set-up, objectives, constraints and patient rights.
• The patient must have given free and informed consent and signed the consent form.
• The patient must be affiliated or a beneficiary of a health insurance plan. Precautions: if the patient is on anticoagulant therapy, an International Normalized Ratio <1.5 is recommended before right heart catheterization and any implantation procedure

Exclusion criteria

• Patients with a contraindication to the CARDIOMEMS™ HF system (pulmonary embolism with sequelae, artery less than 7 mm, active infection).
• Patients already on renal replacement therapy.
• Patients with a history of acute venous thrombosis.
• Patients unable to tolerate right heart catheterization.
• Patients with a major cardiovascular event (i.e., myocardial infarction, stroke) within 2 months of the initial examination.
• Patients with congenital heart disease or mechanical right heart valve(s).
• Patients with known hypersensitivity or allergy to aspirin and/or clopidogrel.
• Patients with a body mass index >35. Measure the patient's chest circumference at the armpit: if the patient's chest circumference is > 165 cm, the sensor should not be implanted.
• Patients unable to take dual anti-platelet therapy or anticoagulant therapy for one month after implantation
• Patient hypersensitive or allergic to iohexol.
• Patient is participating in another Class I interventional study, or has participated in another interventional study within the last 3 months.
• Patient is in an exclusion period determined by a previous study.
• Patient is under guardianship, conservatorship, or conservatorship.
• The patient refuses to sign the consent form.
• It is impossible to give the patient informed information.
• The patient is pregnant or nursing.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Prevention

Study locations

France · 2 centers

• Centre Hospitalier Universitaire de Nîmes — Nîmes
• CHRU de Montpellier - Hôpital Arnaud de Villeneuve — Montpellier

Identifiers

NCT: NCT05428631 · AOI GCS-MERRI/2019/JER001

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗