LINQ for impEdance meAsuremeNt While Off From HF Medication Study
NCT ID: NCT03245281
Last Updated: 2018-06-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
30 participants
INTERVENTIONAL
2017-10-30
2019-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
CROSSOVER
OTHER
NONE
Study Groups
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Diuretic Suspension (DS)
Diuretic Suspension (DS)
Stop diuretic consumption in the 48h before the follow-up visit
Diuretic Increase (DI)
Diuretic Increase (DI)
Double diuretics dosage in the 48h before the follow-up visit
Diuretic and Medication Suspension (DMS)
Diuretic and Medication Suspension (DMS)
Stop diuretic and MRA medication consumption in the 48h before the follow-up visit
Interventions
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Diuretic Suspension (DS)
Stop diuretic consumption in the 48h before the follow-up visit
Diuretic Increase (DI)
Double diuretics dosage in the 48h before the follow-up visit
Diuretic and Medication Suspension (DMS)
Stop diuretic and MRA medication consumption in the 48h before the follow-up visit
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Medtronic BRC
INDUSTRY
Responsible Party
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Principal Investigators
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John Cleland, Prof
Role: STUDY_CHAIR
NHS Greater Glasgow & Clyde
Locations
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Nhs Greater Glasgow & Clyde
Glasgow, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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MDT16014
Identifier Type: -
Identifier Source: org_study_id
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