LINQ for impEdance meAsuremeNt While Off From HF Medication Study

Study Overview
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Brief Summary
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The purpose of this non-randomized, cross-over, unblinded, single-center feasibility study is to assess the sensitivity of the LINQ ICM to measure derived-subcutaneous impedance in patients with heart failure during periods when diuretics and/or HF-medication consumption is increased or suspended for 48 hours (up to 72 hours at physician discretion) and to collect safety information related to HF status and to medication consumption changes.

Detailed Description
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Up to 30 subjects with a clinical diagnosis of Heart Failure will be enrolled in the study. It is expected that the subjects will be enrolled over a period of approximately 6 months. 3 follow up visits are planned at 2, 4 and 6 months (+/- one week) following the LINQ ICM implant. The total expected duration of the study is of about 1 year. According to the enrolment chronological order, each subject will be allocated to Diuretic Suspension group (DS), Diuretic Increase (DI) or Diuretic+MRA medication Suspension (DMS), which will define the medication regimen before the follow-up visit. Primary objective of the study is detecting the variation of impedance magnitude and the time of occurrence after medication regimen changes will be evaluated at each follow-up.

Official Title
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LINQ for impEdance meAsuremeNt While Off From HF Medication Study

Conditions
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Heart Failure

Intervention / Treatment
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* Drug: Diuretic Suspension (DS)
* Drug: Diuretic Increase (DI)
* Drug: Diuretic and Medication Suspension (DMS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical Diagnosis of Heart Failure Plasma NT-proBNP (>250ng/L in SR and >1,000ng/L in AF) LVEF <50% measured in the year before enrolment Treated routinely with a daily dose of loop diuretic Receiving other guideline-indicated therapy for heart failure Willing to sign the informed consent form. Greater than 18 years of age. Exclusion Criteria: Pregnant patients (all females of child-bearing potential must have a negative pregnancy test before LINQ ICM implant) eGFR <30 ml/minute. Any concomitant condition which in the opinion of the investigator would not allow a safe participation in the study. Patients with implanted pacemakers or defibrillators Severe aortic or mitral valve disease Breathlessness at rest or on minor exertion. Chest pain at rest or on mild or moderate exertion. Patients deemed too unstable to miss 48 hours of heart failure treatment Enrolled in another study that could confound the results of this study, without documented pre-approval from Medtronic study manager

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: According to the enrolment chronological order, each subject will be allocated to Diuretic Suspension group (DS), Diuretic Increase (DI) or Diuretic+MRA medication Suspension (DMS), which will define the medication regimen before the follow-up visit.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diuretic Suspension (DS)<br> | Drug: Diuretic Suspension (DS)<br>* Stop diuretic consumption in the 48h before the follow-up visit<br>|
| Experimental: Diuretic Increase (DI)<br> | Drug: Diuretic Increase (DI)<br>* Double diuretics dosage in the 48h before the follow-up visit<br>|
| Experimental: Diuretic and Medication Suspension (DMS)<br> | Drug: Diuretic and Medication Suspension (DMS)<br>* Stop diuretic and MRA medication consumption in the 48h before the follow-up visit<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Derived-subcutaneous impedance | The variation of impedance magnitude and the time of occurrence after medication regimen changes will be detected by the LINQ ICM | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Adverse Events | All AEs related to changes in the therapeutic regimen and/or to HF status will be collected through CRF completion | 6 months | 
| Number of Transitory Arrhythmias | Any transitory arrhythmias related to drug regimen changes and/or HF condition will be collected through CRF completion | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart Failure