We hypothesize that the CardioMEMS HF system will be safe and superior to standard care in improving the quality of life and health status in patients with chronic HF in the Netherlands. Additionally, we hypothesize the CardioMEMS HF system is cost-…
ID
Source
Brief title
Condition
- Heart failures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Quality of life: assessments will be performed using KCCQ questionnaires at
baseline (t=0), either signing informed consent or at admission for the actual
implantation of the device, and at follow-up intervals of 3, 6, and 12 months
follow-up after randomization in both treatment arms. Primary analysis is based
on KCCQ at 6 months and 12 months.
a. Short-term assessment (6 months)
b. Long-term assessment (12 months)
Secondary outcome
The number of HF-hospitalizations in patients randomized to CardioMEMS
HF-system compared to the patients randomized to standard care during
follow-up. The definition of a HF hospitalization is an admission longer than 6
hours and/or the need of intravenous diuretics for decongestion of the patient.
Minimal follow-up will be 12 months for last patient included.
Other secondary endpoints will be all-cause mortality; days alive outside of
the hospital, days admitted in the hospital, number of total hospital
presentations (out-patient clinic, clinical and emergency department) and
change in baseline PA pressure. Duration of HF hospitalization. Number of
medication changes. Additionally, all endpoints will be related to KCCQ health
scores changes. Costeffectiveness wil be calculated using the EQ-5D-5L.
Background summary
Remote monitoring of PA pressures is available with the CardioMEMS PA sensor.
Measuring filling pressures in HF patients can be a way to further improve
outcome and quality of life by intervening before symptoms or weight gain
occurs keeping the patient out of the hospital.
CardioMEMS is not reimbursed in the Netherlands and only available for
scientific purposes. Zorginstituut and the Ministry of Health have granted a
conditional coverage study project considering the highly promising level of
care provided by CardioMEMS monitoring in heart failure patient. If proven
effective in the Dutch health care system, CardioMEMS is covered and reimbursed
by health care insurance in the Netherlands. Through this conditional coverage
initiative, novel promising care is more readily available to chronic HF
patients. The current study design has been set up to answer the questions at
hand for the Ministry of Health. If proven effective and cost-effective in the
Netherlands, CardioMEMS PA monitoring can be requested to be extend from
conditional coverage in clinical trial setting towards complete reimbursement
in the Dutch health care system.
Study objective
We hypothesize that the CardioMEMS HF system will be safe and superior to
standard care in improving the quality of life and health status in patients
with chronic HF in the Netherlands. Additionally, we hypothesize the CardioMEMS
HF system is cost-effective in a Dutch heart failure care program (assessed
with KCCQ, EQ5D5L and reduction in HF hospitalizations).
Study design
The MONITOR HF trial is an investigator initiated, national multicentre
randomised clinical trial enrolling 340 patients with chronic HF NYHA class III
and at least 1 HF hospital admission in the previous 12 months.
Active comparator: standard of HF-care management plus CardioMEMS PA-monitoring
with a treatment algorithm for hemodynamic assessments
Control group: standard practice based HF care
Intervention
Intervention group: implantation CardioMEMS device, incl baseline measurement
of pulmonary pressures (swann ganz cath).
Control group: standard clinical care (according to guidelines).
Study burden and risks
Implantation of the CardioMEMS HF System may offer certain advantages. Studies
to date have demonstrated a reduction in HF-related hospitalizations and
improved quality of life in patients using the CardioMEMS HF System when
compared with patients receiving standard care. Risks associated with the
implantation and use of the device is minor, generally without serious
consequences, and occurs at a low rate. The actual risk associated only with
the deployment of the device is low. The CHAMPION clinical trial reported no
pressure sensor failures, and device/system related complications occurred in
only 1.4 % of the cases (n=8) with the vast majority related to manageable
bleeding complications at the entry site (venous puncture)
's-Gravendijkwal 230
Rotterdam 3015 CE
NL
's-Gravendijkwal 230
Rotterdam 3015 CE
NL
Listed location countries
Age
Inclusion criteria
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
Exclusion criteria
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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL67334.078.18 |
| OMON | NL-OMON28853 |