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

Study Overview
=================
Brief 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.

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

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Device: CardioMEMSTM HF sensor - pulmonary artery pressure measurement


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group<br>Monitoring and therapy adjustment within the scope of the basic care described in the clinical trial plan. | |
| Active Comparator: Intervention Group<br>As in control group. In addition, in the intervention arm the CardioMEMSTM HF sensor implanted. | Device: CardioMEMSTM HF sensor - pulmonary artery pressure measurement<br>* CardioMEMSTM HF sensor implantation to meassure pulmonary artery pressure. Evaluation of the pressure curves by telemetric transmission and coordination of necessary adjustments of the therapy.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary efficacy endpoint: composite of unplanned HF-related rehospitalisations and all-cause death | Composite endpoint of number of unplanned HF-related rehospitalisations or all-cause death | 12 months | 
| Primary safety endpoint: device-related complications | Rate of Device / System related complications | 12 months | 
| Co-primary safety endpoint: sensor failure | Rate of sensor failures | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major secondary endpoint: changes in disease-related quality of life | Change in quality of life score after 6 and 12 month measured by Kansas City Cardiomyopathy questionnaire. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. | 6 and 12 months | 
| Changes in generic health-related quality of life | Change in Quality of Life score after 6 and 12 month measures by EQ-5D questionnaire. The EQ-5D-5L descriptive system comprises the five dimensions (MOBILITY, SELF-CARE, USUAL ACTIVITIES, PAIN / DISCOMFORT and ANXIETY / DEPRESSION), each dimension has five response levels: no problems, slight problems, moderate problems, severe problems, unable to /extreme problems. Responses are coded as single-digit numbers expressing the severity level selected in each dimension (1 - 5, where higher scores indicate more severe problems). The EQ VAS records the respondent's overall current health on a vertical visual analogue scale (0-100), where the endpoints are labelled 'The best health you can imagine - 100' and 'The worst health you can imagine - 0'. The EQ VAS provides a quantitative measure of the patient's perception of their overall health. | 6 and 12 months | 
| HF-related mortality | Rate of HF-related mortality | 12 months | 
| Cardiovascular Mortality | Rate of cardiovascular mortality | 12 months | 
| All-cause Mortality | Rate of all-cause mortality | 12 months | 
| Unplanned HF-related hospitalizations | Rate of HF-related hospitalisations | 12 months | 
| Unplanned cardiovascular-related hospitalizations | Rate of cardiovascular-related hospitalisations | 12 months | 
| Unplanned all-cause hospitalizations | Rate of all-cause hospitalisations | 12 months | 
| Unplanned hospitalizations, other | Number of days alive and out of hospital | 12 months | 
| Non-serious Adverse Events | Rate of non-serious adverse events | 12 months | 
| Serious Adverse Events | Rate of serious adverse events | 12 months | 
| Symptoms of heart failure | Patient-reported symptoms of heart failure, measured by of the KCCQ Symptoms Score | 12 months |