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

NCT05428631 | Recruiting

• 1 other identifier: AOI GCS-MERRI/2019/JER001
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Heart Failure; Renal Insufficiency

Keywords

Renal insufficiency,; heart failure,; medical device; blood pressure monitoring; tolerance

Outcome Measures

Primary Outcomes (13)

• Adverse events

  Perioperative collection of complications related to the puncture site (hematoma, arteriovenous fistula) and right catheterization (arrhythmia, peri-procedure heart failure decompensation).

  On the day of implanting the Cardiomems device

• Adverse events

  Monthly collection of adverse events over the 12-month follow-up period. In particular, cardiac parameters will be collected (sensor failure, migration, re-calibration, re-intervention, gas embolism, allergic reaction, abnormal heart rate or rhythm, bleeding, hematoma, chest pain, nausea, vascular accident, infection, sepsis, delayed healing, atrial dysrhythmia clot formation, ecchymosis, vascular trauma, valve damage, pulmonary infarction, pulmonary embolism, heart attack (myocardial infarction), death, hemoptysis, separation of sensor and delivery system impossible) and renal (risk of infection, thrombotic risk, interference with dialysis catheter placement).

  One month after implanting the Cardiomems device

• Adverse events

  Perioperative collection of complications related to the puncture site (hematoma, arteriovenous fistula) and right catheterization (arrhythmia, peri-procedure heart failure decompensation). Monthly collection of adverse events over the 12-month follow-up period. In particular, cardiac parameters will be collected (sensor failure, migration, re-calibration, re-intervention, gas embolism, allergic reaction, abnormal heart rate or rhythm, bleeding, hematoma, chest pain, nausea, vascular accident, infection, sepsis, delayed healing, atrial dysrhythmia clot formation, ecchymosis, vascular trauma, valve damage, pulmonary infarction, pulmonary embolism, heart attack (myocardial infarction), death, hemoptysis, separation of sensor and delivery system impossible) and renal (risk of infection, thrombotic risk, interference with dialysis catheter placement).

  Two months after implanting the Cardiomems device

• Adverse events

  Monthly collection of adverse events over the 12-month follow-up period. In particular, cardiac parameters will be collected (sensor failure, migration, re-calibration, re-intervention, gas embolism, allergic reaction, abnormal heart rate or rhythm, bleeding, hematoma, chest pain, nausea, vascular accident, infection, sepsis, delayed healing, atrial dysrhythmia clot formation, ecchymosis, vascular trauma, valve damage, pulmonary infarction, pulmonary embolism, heart attack (myocardial infarction), death, hemoptysis, separation of sensor and delivery system impossible) and renal (risk of infection, thrombotic risk, interference with dialysis catheter placement).

  Three months after implanting the Cardiomems device

• Adverse events

  Monthly collection of adverse events over the 12-month follow-up period. In particular, cardiac parameters will be collected (sensor failure, migration, re-calibration, re-intervention, gas embolism, allergic reaction, abnormal heart rate or rhythm, bleeding, hematoma, chest pain, nausea, vascular accident, infection, sepsis, delayed healing, atrial dysrhythmia clot formation, ecchymosis, vascular trauma, valve damage, pulmonary infarction, pulmonary embolism, heart attack (myocardial infarction), death, hemoptysis, separation of sensor and delivery system impossible) and renal (risk of infection, thrombotic risk, interference with dialysis catheter placement).

  Four months after implanting the Cardiomems device

• Adverse events

  Monthly collection of adverse events over the 12-month follow-up period. In particular, cardiac parameters will be collected (sensor failure, migration, re-calibration, re-intervention, gas embolism, allergic reaction, abnormal heart rate or rhythm, bleeding, hematoma, chest pain, nausea, vascular accident, infection, sepsis, delayed healing, atrial dysrhythmia clot formation, ecchymosis, vascular trauma, valve damage, pulmonary infarction, pulmonary embolism, heart attack (myocardial infarction), death, hemoptysis, separation of sensor and delivery system impossible) and renal (risk of infection, thrombotic risk, interference with dialysis catheter placement).

  Five months after implanting the Cardiomems device

• Adverse events

  Monthly collection of adverse events over the 12-month follow-up period. In particular, cardiac parameters will be collected (sensor failure, migration, re-calibration, re-intervention, gas embolism, allergic reaction, abnormal heart rate or rhythm, bleeding, hematoma, chest pain, nausea, vascular accident, infection, sepsis, delayed healing, atrial dysrhythmia clot formation, ecchymosis, vascular trauma, valve damage, pulmonary infarction, pulmonary embolism, heart attack (myocardial infarction), death, hemoptysis, separation of sensor and delivery system impossible) and renal (risk of infection, thrombotic risk, interference with dialysis catheter placement).

  Six months after implanting the Cardiomems device

• Adverse events

  Monthly collection of adverse events over the 12-month follow-up period. In particular, cardiac parameters will be collected (sensor failure, migration, re-calibration, re-intervention, gas embolism, allergic reaction, abnormal heart rate or rhythm, bleeding, hematoma, chest pain, nausea, vascular accident, infection, sepsis, delayed healing, atrial dysrhythmia clot formation, ecchymosis, vascular trauma, valve damage, pulmonary infarction, pulmonary embolism, heart attack (myocardial infarction), death, hemoptysis, separation of sensor and delivery system impossible) and renal (risk of infection, thrombotic risk, interference with dialysis catheter placement).

  Seven months after implanting the Cardiomems device

• Adverse events

  Monthly collection of adverse events over the 12-month follow-up period. In particular, cardiac parameters will be collected (sensor failure, migration, re-calibration, re-intervention, gas embolism, allergic reaction, abnormal heart rate or rhythm, bleeding, hematoma, chest pain, nausea, vascular accident, infection, sepsis, delayed healing, atrial dysrhythmia clot formation, ecchymosis, vascular trauma, valve damage, pulmonary infarction, pulmonary embolism, heart attack (myocardial infarction), death, hemoptysis, separation of sensor and delivery system impossible) and renal (risk of infection, thrombotic risk, interference with dialysis catheter placement).

  Eight months after implanting the Cardiomems device

• Adverse events

  Monthly collection of adverse events over the 12-month follow-up period. In particular, cardiac parameters will be collected (sensor failure, migration, re-calibration, re-intervention, gas embolism, allergic reaction, abnormal heart rate or rhythm, bleeding, hematoma, chest pain, nausea, vascular accident, infection, sepsis, delayed healing, atrial dysrhythmia clot formation, ecchymosis, vascular trauma, valve damage, pulmonary infarction, pulmonary embolism, heart attack (myocardial infarction), death, hemoptysis, separation of sensor and delivery system impossible) and renal (risk of infection, thrombotic risk, interference with dialysis catheter placement).

  Nine months after implanting the Cardiomems device

• Adverse events

  Monthly collection of adverse events over the 12-month follow-up period. In particular, cardiac parameters will be collected (sensor failure, migration, re-calibration, re-intervention, gas embolism, allergic reaction, abnormal heart rate or rhythm, bleeding, hematoma, chest pain, nausea, vascular accident, infection, sepsis, delayed healing, atrial dysrhythmia clot formation, ecchymosis, vascular trauma, valve damage, pulmonary infarction, pulmonary embolism, heart attack (myocardial infarction), death, hemoptysis, separation of sensor and delivery system impossible) and renal (risk of infection, thrombotic risk, interference with dialysis catheter placement).

  Ten months after implanting the Cardiomems device

• Adverse events

  Monthly collection of adverse events over the 12-month follow-up period. In particular, cardiac parameters will be collected (sensor failure, migration, re-calibration, re-intervention, gas embolism, allergic reaction, abnormal heart rate or rhythm, bleeding, hematoma, chest pain, nausea, vascular accident, infection, sepsis, delayed healing, atrial dysrhythmia clot formation, ecchymosis, vascular trauma, valve damage, pulmonary infarction, pulmonary embolism, heart attack (myocardial infarction), death, hemoptysis, separation of sensor and delivery system impossible) and renal (risk of infection, thrombotic risk, interference with dialysis catheter placement).

  Eleven months after implanting the Cardiomems device

• Adverse events

  Monthly collection of adverse events over the 12-month follow-up period. In particular, cardiac parameters will be collected (sensor failure, migration, re-calibration, re-intervention, gas embolism, allergic reaction, abnormal heart rate or rhythm, bleeding, hematoma, chest pain, nausea, vascular accident, infection, sepsis, delayed healing, atrial dysrhythmia clot formation, ecchymosis, vascular trauma, valve damage, pulmonary infarction, pulmonary embolism, heart attack (myocardial infarction), death, hemoptysis, separation of sensor and delivery system impossible) and renal (risk of infection, thrombotic risk, interference with dialysis catheter placement).

  Twelve months after implanting the Cardiomems device

Secondary Outcomes (109)

• Estimated effect on renal function

  Between 1 day to 1 month before implanting the device.

• Measured effect on renal function

  Between 1 day to 1 month before implanting the device.

• Estimated effect on renal function

  Day 0 (day of implanting the device)

• Measured effect on renal function

  Day 0 (day of implanting the device)

• Estimated effect on renal function

  Month 3

Other Outcomes (15)

• Age of patients

  Day 0

• Weight of patients

  Day 0

• Height of patients

  Day 0

Study Arms (1)

CARDIOMEMS(TM) HF device

EXPERIMENTAL

Renal failure patients testing the CARDIOMEMS(TM) HF device

Device: Implantation of the CARDIOMEMS™ HF device

Interventions

Implantation of the CARDIOMEMS™ HF device 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.

Also known as: Nephrolocical evaluation measured with the CARDIOMEMS™ HF device

CARDIOMEMS(TM) HF device

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead
• CHU Arnaud de Villeneuve MONTPELLIER: collaborator

Study Sites (2)

Centre Hospitalier Universitaire de Nîmes

Nîmes, Gard, 30029, France

RECRUITING

CHRU de Montpellier - Hôpital Arnaud de Villeneuve

Montpellier, 34295, France

RECRUITING

MeSH Terms

Conditions

Heart Failure; Renal Insufficiency

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Jean-Etienne RICCI, Dr.

  Nîmes University Hospital

  PRINCIPAL INVESTIGATOR

• François ROUBILLE, Prof.

  CHU Arnaud de Villeneuve MONTPELLIER

  PRINCIPAL INVESTIGATOR

• Guillaume CAYLA, Prof.

  Nîmes University Hospital

  PRINCIPAL INVESTIGATOR

• Sylvain AGUILHON, Dr.

  CHU Arnaud de Villeneuve MONTPELLIER

  PRINCIPAL INVESTIGATOR

• Sylvain CARIOU, Dr.

  Nîmes University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Olivier MORANNE, Prof.

CONTACT

+33 4.66.68.31.49; olivier.moranne@chu-nimes.fr

Anissa MEGZARI

CONTACT

+33466684236; drc@chu-nimes.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be pre-selected (pre-inclusion visit) during hospitalizations in the cardiology and nephrology departments of the Nîmes University Hospital. The study will be offered to any patient with class NYHA III heart failure who has been hospitalized in the previous 12 months for cardiac decompensation (current indication for the CARDIOMEMS™ system) and with advanced chronic renal failure with GFR (CKD-EPI) \< 30 ml/min/1.73m2 persisting for more than 3 months and confirmed by Iohexol clearance.

Study Record Dates

• First Submitted: May 12, 2022
• First Posted: June 23, 2022
• Study Start: August 26, 2022
• Primary Completion (Estimated): August 26, 2026
• Study Completion (Estimated): August 26, 2027
• Last Updated: December 10, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)