Hemodynamic Monitoring with the CardioMEMS PA sensor and Quality of Life in Patients with Chronic Heart Failure: The MONITOR HF Trial
- Conditions
- heart failurepump dysfunction10019280
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 340
1. Written informed consent obtained from subject aged >18 years
2. Diagnosis of NYHA-Class III heart failure with at least 1 (additional) HF
hospitalization within 12 months of baseline visit (independent of EF %)
3. Subjects with reduced EF (HFrEF) should be treated according to National and
International (ESC) guidelines for optimal or maximum tolerated doses of HF
medication and evaluated for ICD or CRT-D therapy if indicated.
4. Subjects with a BMI <=35. Subjects with BMI >35 will require their chest
circumference to be measured at the axillary level <65 inches (related to
distance of the sensor)
5. Subjects willing and able to comply with the follow-up requirements of the
study
1. Subjects with an active infection
2. Subjects with history of recurrent (>1) pulmonary embolism or deep vein
thrombosis
3. Subjects who have had a major cardiovascular event (e.g., myocardial
infarction, open heart surgery, stroke) within 2 months
4. Subjects with Cardiac Resynchronization Device (CRT) implanted <3 months
prior to enrolment and implantation of the sensor (in order to avoid
manipulation of lead)
5. Subjects with a Glomerular Filtration Rate (GFR) <25 ml/min (obtained within
2 weeks of the baseline visit), refractory to diuretic therapy or on chronic
renal dialysis
6. Subjects with complex congenital heart disease or mechanical right heart
valve(s)
7. Subjects is scheduled for or likely to undergo heart-transplantation or VAD
within 6 months of baseline visit
8. Subjects with known coagulation disorders or allergy to aspirin, and/or
clopidogrel.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Quality of life: assessments will be performed using KCCQ questionnaires at<br /><br>baseline (t=0), either signing informed consent or at admission for the actual<br /><br>implantation of the device, and at follow-up intervals of 3, 6, and 12 months<br /><br>follow-up after randomization in both treatment arms. Primary analysis is based<br /><br>on KCCQ at 6 months and 12 months.<br /><br>a. Short-term assessment (6 months)<br /><br>b. Long-term assessment (12 months)</p><br>
- Secondary Outcome Measures
Name Time Method <p>The number of HF-hospitalizations in patients randomized to CardioMEMS<br /><br>HF-system compared to the patients randomized to standard care during<br /><br>follow-up. The definition of a HF hospitalization is an admission longer than 6<br /><br>hours and/or the need of intravenous diuretics for decongestion of the patient.<br /><br>Minimal follow-up will be 12 months for last patient included.<br /><br><br /><br>Other secondary endpoints will be all-cause mortality; days alive outside of<br /><br>the hospital, days admitted in the hospital, number of total hospital<br /><br>presentations (out-patient clinic, clinical and emergency department) and<br /><br>change in baseline PA pressure. Duration of HF hospitalization. Number of<br /><br>medication changes. Additionally, all endpoints will be related to KCCQ health<br /><br>scores changes. Costeffectiveness wil be calculated using the EQ-5D-5L.</p><br>