Clinical trial NCT03245281: LINQ for impEdance meAsuremeNt While Off From HF Medication Study
Official title: LINQ for impEdance meAsuremeNt While Off From HF Medication Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Heart Failure
Keywords: Heart Failure
Lead sponsor: Medtronic BRC
Sponsor class: INDUSTRY
First posted: 2017-08-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: OTHER

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Derived-subcutaneous impedance
timeFrame: 2 months
Secondary outcomes:
measure: Number of Adverse Events
timeFrame: 6 months
measure: Number of Transitory Arrhythmias
timeFrame: 6 months
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: Nhs Greater Glasgow & Clyde
Study officials:
affiliation: NHS Greater Glasgow & Clyde
name: John Cleland, Prof
role: STUDY_CHAIR
References:
citation: Rosamond W, Flegal K, Furie K, Go A, Greenlund K, Haase N, Hailpern SM, Ho M, Howard V, Kissela B, Kittner S, Lloyd-Jones D, McDermott M, Meigs J, Moy C, Nichol G, O'Donnell C, Roger V, Sorlie P, Steinberger J, Thom T, Wilson M, Hong Y; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2008 update: a report from the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Circulation. 2008 Jan 29;117(4):e25-146. doi: 10.1161/CIRCULATIONAHA.107.187998. Epub 2007 Dec 17. No abstract available.
citation: Osterberg L, Blaschke T. Adherence to medication. N Engl J Med. 2005 Aug 4;353(5):487-97. doi: 10.1056/NEJMra050100. No abstract available.
citation: Butler J, Arbogast PG, Daugherty J, Jain MK, Ray WA, Griffin MR. Outpatient utilization of angiotensin-converting enzyme inhibitors among heart failure patients after hospital discharge. J Am Coll Cardiol. 2004 Jun 2;43(11):2036-43. doi: 10.1016/j.jacc.2004.01.041.
citation: Monane M, Bohn RL, Gurwitz JH, Glynn RJ, Avorn J. Noncompliance with congestive heart failure therapy in the elderly. Arch Intern Med. 1994 Feb 28;154(4):433-7.
citation: Mittal S, Sanders P, Pokushalov E, Dekker L, Kereiakes D, Schloss EJ, Pouliot E, Franco N, Zhong Y, DI Bacco M, Purerfellner H. Safety Profile of a Miniaturized Insertable Cardiac Monitor: Results from Two Prospective Trials. Pacing Clin Electrophysiol. 2015 Dec;38(12):1464-9. doi: 10.1111/pace.12752. Epub 2015 Oct 20.
citation: Purerfellner H, Sanders P, Pokushalov E, Di Bacco M, Bergemann T, Dekker LR; Reveal LINQ Usability Study Investigators. Miniaturized Reveal LINQ insertable cardiac monitoring system: First-in-human experience. Heart Rhythm. 2015 Jun;12(6):1113-9. doi: 10.1016/j.hrthm.2015.02.030. Epub 2015 Feb 26.
citation: van der Wal MH, Jaarsma T, van Veldhuisen DJ. Non-compliance in patients with heart failure; how can we manage it? Eur J Heart Fail. 2005 Jan;7(1):5-17. doi: 10.1016/j.ejheart.2004.04.007.