Monitoring heart and kidney health with a special device in patients with severe kidney issues

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

This study is testing a special device that continuously checks heart pressure to see if it can help people with severe kidney problems and heart failure feel better and manage their symptoms.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Centre Hospitalier Universitaire de Nīmes (other)
• Locations: 2 sites (Nîmes, Gard and 1 other locations)
• Trial ID: NCT05428631 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and tolerability of the CARDIOMEMS™ device, which continuously monitors pulmonary artery pressure in patients suffering from both heart failure and severe renal impairment. It aims to include patients with New York Heart Association class III heart failure who have been hospitalized in the past year and have a Glomerular Filtration Rate of less than 30 ml/min/1.73m2. By implanting the device, the study seeks to provide real-time data that could lead to better management of heart failure symptoms and potentially improve patient outcomes. The study is particularly focused on a population that has been previously excluded from similar research, addressing a significant gap in treatment options.

Who should consider this trial

Good fit: Ideal candidates are patients with NYHA class III heart failure and advanced renal failure, specifically those with a GFR of less than 30 ml/min/1.73m2.

Not a fit: Patients with heart failure who do not have significant renal impairment or those with a GFR above 30 ml/min/1.73m2 may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved management of heart failure symptoms and reduced hospitalizations for patients with severe renal impairment.

How similar studies have performed: While previous studies have shown success with the CARDIOMEMS™ device in heart failure patients without renal impairment, this specific approach in patients with severe renal issues is novel and untested.

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.

Where this trial is running

Nîmes, Gard and 1 other locations

• Centre Hospitalier Universitaire de Nîmes — Nîmes, Gard, France (RECRUITING)
• CHRU de Montpellier - Hôpital Arnaud de Villeneuve — Montpellier, France (RECRUITING)

Study contacts

• Principal investigator: Jean-Etienne RICCI, Dr. — Nîmes University Hospital
• Study coordinator: Olivier MORANNE, Prof.

Conditions: Heart Failure, Renal Insufficiency, Renal insufficiency,, heart failure,, medical device, blood pressure monitoring, tolerance