Pulmonary Artery Sensor System Pressure Monitoring to Improve Heart Failure (HF) Outcomes

Launched by IHF GMBH - INSTITUT FÜR HERZINFARKTFORSCHUNG · May 18, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a new way to help patients with heart failure by using a special device called the CardioMEMS™ HF system, which measures pressure in the pulmonary artery. The goal is to see if this pressure monitoring can improve patients' health outcomes, safety, and overall quality of life. Participants in the trial will be adults aged 18 and older who have experienced significant heart failure symptoms recently and have been hospitalized for their condition within the past year. They will receive standard care, but those in the intervention group will also have the pressure sensor implanted to help guide their treatment.

If you or a loved one is considering participation, it is important to know that candidates must be able to tolerate certain heart medications and have specific health conditions. Throughout the study, participants will be monitored over a 12-month follow-up period. They will receive support from trained staff, who will help adjust treatments based on the pressure readings from the sensor. This trial is currently recruiting participants and aims to enhance management of heart failure, which can lead to better health and a higher quality of life.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Written consent received from the patient or a legal representative after the in-formation has been provided.
• • 2. ≥≥ 18 years of age.
• • 3. Predominant symptoms in NYHA Stage III in the 30-day period prior to consent to the study.
• • 4. Objectified HF diagnosis for more than three months.
• • 5. Hospitalisation within 12 months prior to inclusion due to deterioration of HF symptoms.
• • 6. Able to tolerate dual antiplatelet therapy or anticoagulation therapy for one month after sensor implantation
• • 7. Patients with reduced left ventricular ejection fraction (LVEF) ≤40% (diagnosed within 6 months prior to inclusion) must be treated with guideline-compliant HF pharmacotherapy; if one class of guideline-compliant medication is not tolerated, appropriate documentation must be supplied; patients must receive and tolerate at least one class of guideline-compliant medication; if no guideline-compliant medication is tolerated at all, the patient may not participate in the study.
• • 8. In patients with preserved LVEF (\>40%; diagnosed within 6 months prior to inclu-sion) comorbidities must be treated in accordance with guideline-compliant medi-cation.
• • 9. Chest circumference (measured at axillary level) of less than 165 cm if BMI \>35 kg/m2.
• • 10. Willing and mentally and physically able to meet the requirements for follow-up and long-term basic care (this includes the long-term willingness of the patient, and of their relatives where relevant, to participate in PA pressure-based monitor-ing).
• • 11. Appropriate domestic situation, defined as being accessible by telephone (via fixed or mobile network) .
• • 12. For the intervention group: Implantation is only performed if the diameter of the pulmonary artery branch intended for implantation is ≥7 mm (assessment will be made during the right heart catheterization)
• Exclusion criteria:
• • 1. Enrolment in another study with an active treatment arm.
• • 2. Severe cardiovascular event (e.g. myocardial infarction, open heart surgery, stroke, CRT implantation) in the 2 months prior to admission
• • 3. Therapy-refractory heart failure in ACC/AHA stage D or new therapies that have taken place or are planned in the next 12 months (e.g. implantation of a left ven-tricular assist system / transplantation)
• • 4. Active infection.
• • 5. History of recurrent (\>1 episode) pulmonary embolism and/or deep vein throm-bosis.
• • 6. Continuous or intermittent chronic inotropic therapy.
• • 7. Estimated glomerular filtration rate (eGFR) \<25 ml/min
• • 8. Life expectancy (according to the study physician's assessment) \<12 months.
• • 9. Severe, unrepaired congenital heart defect that would prevent implantation of the sensor.
• • 10. Severe valve vitium with planned intervention in the next 3 months
• • 11. Presence of a mechanical right heart valve.
• • 12. Mental disorder that presumably (in the opinion of the study physician) has a negative impact on patient compliance or consent.
• • 13. Failure of the coordinating physician to approve if the patient is enrolled in an HF disease management program or comparable case management program.
• • 14. Women of childbearing age with a positive pregnancy test at the time of inclusion