Introduction
Patients and methods
Legal framework
Study design, eligibility criteria for study sites and patients, and main hypothesis
1 | Written informed consent received from the patient or a legal representative after the information 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 3 months |
5 | Hospitalization within 12 months prior to inclusion due to deterioration of HF symptoms |
6 | Able to tolerate dual antiplatelet therapy or anticoagulation therapy for 1 month after sensor implantation |
7 | Patients with reduced left ventricular ejection fraction (LVEF) ≤ 40% (assessed 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%; assessed within 6 months prior to inclusion), comorbidities must be treated in accordance with guideline-compliant medication |
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 monitoring) |
11 | Appropriate domestic situation, defined as being accessible by telephone (via fixed or mobile network)a |
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) |
1 | Enrollment 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 ventricular assist system / transplantation) |
4 | Active infection |
5 | History of recurrent (> 1 episode) pulmonary embolism and/or deep vein thrombosis |
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 programa |
14 | Women of childbearing age with a positive pregnancy test at the time of inclusion |
Randomization
CardioMEMS™ HF-System
Basic HF care
Component | Description |
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Patient training at study start | An educational session with specialized HF staff while the patient is still in hospital; with the option to repeat educational segments during subsequent telephone calls, if required |
Patient manual | An illustrated brochure handed out at study start; it informs on HF symptoms, medication, and gives advice regarding self-care, life-style adjustments, and emergency measures; during telephone follow-up calls, specialized HF staff can refer to its content |
Symptom calendar | Booklet for daily self-recording of the patient´s body weight, blood pressure, heart rate, and symptoms |
Repetitive structured telephone contact | Weekly calls in the first month after study initiation, then bi-weekly calls for patients in NYHA class III/IV, and 4-weekly calls for patients in NYHA class I/II for the remainder of the study period; contents of these contacts are documented in a structured fashion; a modified 14-item questionnaire [5] will be used addressing general health status, most recent self-measured values, indicators of deteriorating HF, well-being, and (changes in) medication; all educational elements relate to recommendations listed in the The German National Disease Management Guideline “Chronic Heart Failure” (Nationale VersorgungsLeitlinie Chronische Herzinsuffizienz, https://www.leitlinien.de/nvl/herzinsuffizienz) |
Usual medical care | Treatment of HF and concomitant diseases by means of guideline-directed therapy and routine pathways established at the respective site or region |
CardioMEMS™ HF supported care
Clinical study flow
Patient visits
Impact of the COVID-19 pandemic
Outcome measures
Primary end point
Secondary end points
Primary efficacy end point | Composite of the number of unplanned HF-related rehospitalizations or all-cause mortality 365 days after randomization (12-month time) |
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Primary safety end point | 1. Device/system-related complications (DSRC) of the patients as a result of the attempted or successful implantation of an CardioMEMS™ sensor at the 12-month time point and 2. Freedom from sensor failures at the 12-month time |
Secondary end points | (A) Health-related quality of life Major secondary: changes in quality of life (QoL) measured using the Kansas City Cardiomyopathy Questionnaire (KCCQ) scores (TSS, OSS, CSS), after 6 and 12 months Changes in QoL scores measured after 6 and 12 months using Euro-QoL-5D (B) Mortality HF-related mortality in the 12-month period Other cardiovascular mortality in the 12-month period Non-cardiovascular mortality in the 12-month period All-cause mortality in the 12-month period (C) Unplanned hospitalizations HF-related hospitalizations in the 12-month period Other cardiac-related hospitalizations in the 12-month period Non-cardiovascular-related hospitalizations in the 12-month period All-cause hospitalizations in the 12-month period Number of days alive and out of hospital in the 12-month period (D) Adverse events Frequency of adverse events in the 12-month period Frequency of serious adverse events in the 12-month period (E) Symptoms of heart failure and psychometric assessments Patient-reported symptoms of heart failure assessed by the KCCQ Symptoms Score Unscheduled HF-related hospitalizations HF-related mortality Days alive and out of hospital Laboratory parameters for organ damage and disease progression Change in symptom burden of anxiety (GAD-7) at 6- and 12-month time points Change in symptom burden of depressive symptoms (PHQ-9) at 6- and 12-month time points (F) Care-related aspects Patient adherence in the intervention group in terms of obtaining PA pressure readings, at 6 and 12 months Change in PA pressure values at 6 and 12 months, based on the area under the curve Number of adjustments made within each guideline-recommended substance class and their underlying reasons Change in drug dose (equivalent dosages) of maximum guideline-recommended substance class received, at 6 and 12 months Rate of documented atrial and ventricular arrhythmias over a 12-month period Laboratory measures of organ damage and disease progression: renal and cardiac biomarkers with associated changes Health economic data (resource use) at 6- and 12-month time points |