RecruitingNot ApplicableNCT05428631

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

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

Sponsor

Centre Hospitalier Universitaire de Nīmes

Enrollment

10 participants

Start Date

Aug 26, 2022

Study Type

INTERVENTIONAL

Conditions

Heart Failure Renal Insufficiency

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a small wireless sensor called CardioMEMS — already approved to monitor heart pressures in heart failure patients — is safe and usable in people who have both severe heart failure and advanced kidney disease. Normally, patients with severe kidney disease are excluded from using this device, and this trial is checking whether it is still safe for them. **You may be eligible if:** - You have Class III heart failure (significant symptoms with mild activity) and have been hospitalized in the past 12 months for heart decompensation - You have advanced kidney disease (GFR below 30 ml/min for more than 3 months) - Your pulmonary artery is large enough for the device (over 7 mm) - You have given informed consent **You may NOT be eligible if:** - You are already on dialysis - You have had a recent blood clot in your veins - You have a contraindication to the CardioMEMS device (e.g., pulmonary embolism, active infection) - You cannot tolerate the right heart catheterization procedure needed to implant the sensor - You had a major cardiovascular event (heart attack or stroke) within the past 2 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEImplantation 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, ferritin, CST), echocardiography (Left Ventricle Ejection Fraction, E/A, E/e', indexed volume of the left atrium, Tricuspid Annular Plane Systolic Excursion, Tissue Doppler S-wave, surface area of the right atrium, Systolic Pulmonary Artery Pressure, Right Atrial Pressure). The device will be implanted in the selected patients by Pr François Roubille at Montpellier University Hospital within 1 month of the pre-inclusion visit. It will monitor their pulmonary artery pressure.