NL-OMON52937
Completed
Not Applicable
Hemodynamic Monitoring with the CardioMEMS PA sensor and Quality of Life in Patients with Chronic Heart Failure: The MONITOR HF Trial - MONITOR HF Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Erasmus MC, Universitair Medisch Centrum Rotterdam
- Enrollment
- 340
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Exclusion Criteria
- •1\. Subjects with an active infection
- •2\. Subjects with history of recurrent (\>1\) pulmonary embolism or deep vein
- •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
Outcomes
Primary Outcomes
Not specified
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