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

  • STATUS
    Recruiting
  • End date
    May 30, 2024
  • participants needed
    554
  • sponsor
    IHF GmbH - Institut für Herzinfarktforschung
Updated on 23 March 2022
ejection fraction
heart failure

Summary

Randomized, parallel group controlled study examines the effect of supporting the Heart failure supply through pulmonary arterial (PA) pressure measurement with the CardioMEMS™ HF system to hard endpoints, safety and quality of life. The target population consists of heart failure (HF) patients who have been predominantly in New York Heart Association (NYHA) Stage III for the past 30 days and at least once in the past 12 months for HF were admitted to hospital. All patients receive basic care, which is based on structured telephone contact (between the care center, patient and family doctor) to optimize guideline compliant therapy. In the intervention group a PA pressure sensor is (CardioMEMS™-HF Sensor) implanted. These patients are structured by specially trained non-medical personnel aftercare with additional inclusion of the PA pressure values: adjusted to the basis of the information collected in PA monitoring the therapy is optimized. The follow-up period until the primary endpoint is 12 months.

Details
Condition Heart Failure
Treatment CardioMEMSTM HF sensor - pulmonary artery pressure measurement
Clinical Study IdentifierNCT04398654
SponsorIHF GmbH - Institut für Herzinfarktforschung
Last Modified on23 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Written consent received from the patient or a legal representative after the in-formation has been provided
≥≥ 18 years of age
Predominant symptoms in NYHA Stage III in the 30-day period prior to consent to the study
Objectified HF diagnosis for more than three months
Hospitalisation within 12 months prior to inclusion due to deterioration of HF symptoms
Able to tolerate dual antiplatelet therapy or anticoagulation therapy for one month after sensor implantation
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
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
Chest circumference (measured at axillary level) of less than 165 cm if BMI >35 kg/m2
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)
Appropriate domestic situation, defined as being accessible by telephone (via fixed or mobile network)
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

Enrolment in another study with an active treatment arm
Severe cardiovascular event (e.g. myocardial infarction, open heart surgery, stroke, CRT implantation) in the 2 months prior to admission
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)
Active infection
History of recurrent (>1 episode) pulmonary embolism and/or deep vein throm-bosis
Continuous or intermittent chronic inotropic therapy
Estimated glomerular filtration rate (eGFR) <25 ml/min
Life expectancy (according to the study physician's assessment) <12 months
Severe, unrepaired congenital heart defect that would prevent implantation of the sensor
Severe valve vitium with planned intervention in the next 3 months
Presence of a mechanical right heart valve
Mental disorder that presumably (in the opinion of the study physician) has a negative impact on patient compliance or consent
Failure of the coordinating physician to approve if the patient is enrolled in an HF disease management program or comparable case management program
Women of childbearing age with a positive pregnancy test at the time of inclusion
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