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LINQ for impEdance meAsuremeNt While Off From HF Medication Study (LEAN HF)

Primary Purpose

Heart Failure

Status
Unknown status
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
Diuretic Suspension (DS)
Diuretic Increase (DI)
Diuretic and Medication Suspension (DMS)
Sponsored by
Medtronic BRC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Heart Failure focused on measuring Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Nhs Greater Glasgow & ClydeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Diuretic Suspension (DS)

Diuretic Increase (DI)

Diuretic and Medication Suspension (DMS)

Arm Description

Outcomes

Primary Outcome Measures

Derived-subcutaneous impedance
The variation of impedance magnitude and the time of occurrence after medication regimen changes will be detected by the LINQ ICM

Secondary Outcome Measures

Number of Adverse Events
All AEs related to changes in the therapeutic regimen and/or to HF status will be collected through CRF completion
Number of Transitory Arrhythmias
Any transitory arrhythmias related to drug regimen changes and/or HF condition will be collected through CRF completion

Full Information

First Posted
July 7, 2017
Last Updated
June 19, 2018
Sponsor
Medtronic BRC
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1. Study Identification

Unique Protocol Identification Number
NCT03245281
Brief Title
LINQ for impEdance meAsuremeNt While Off From HF Medication Study
Acronym
LEAN HF
Official Title
LINQ for impEdance meAsuremeNt While Off From HF Medication Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 30, 2017 (Actual)
Primary Completion Date
January 2019 (Anticipated)
Study Completion Date
April 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic BRC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Heart Failure

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
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)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Diuretic Suspension (DS)
Arm Type
Experimental
Arm Title
Diuretic Increase (DI)
Arm Type
Experimental
Arm Title
Diuretic and Medication Suspension (DMS)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Diuretic Suspension (DS)
Intervention Description
Stop diuretic consumption in the 48h before the follow-up visit
Intervention Type
Drug
Intervention Name(s)
Diuretic Increase (DI)
Intervention Description
Double diuretics dosage in the 48h before the follow-up visit
Intervention Type
Drug
Intervention Name(s)
Diuretic and Medication Suspension (DMS)
Intervention Description
Stop diuretic and MRA medication consumption in the 48h before the follow-up visit
Primary Outcome Measure Information:
Title
Derived-subcutaneous impedance
Description
The variation of impedance magnitude and the time of occurrence after medication regimen changes will be detected by the LINQ ICM
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Number of Adverse Events
Description
All AEs related to changes in the therapeutic regimen and/or to HF status will be collected through CRF completion
Time Frame
6 months
Title
Number of Transitory Arrhythmias
Description
Any transitory arrhythmias related to drug regimen changes and/or HF condition will be collected through CRF completion
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Teodora Bellone
Phone
433566566
Ext
0031
Email
teodora.bellone@medtronic.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mirko De Melis
Email
mirko.de.melis@medtronic.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Cleland, Prof
Organizational Affiliation
NHS Greater Glasgow & Clyde
Official's Role
Study Chair
Facility Information:
Facility Name
Nhs Greater Glasgow & Clyde
City
Glasgow
ZIP/Postal Code
G12 0XH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clare Murphy, Dr
Email
claremurphy4@nhs.net

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
18086926
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. Erratum In: Circulation. 2010 Jul 6;122(1):e10. Kissela, Bret [corrected to Kissela, Brett].
Results Reference
background
PubMed Identifier
16079372
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.
Results Reference
background
PubMed Identifier
15172409
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.
Results Reference
background
PubMed Identifier
8117176
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.
Results Reference
background
PubMed Identifier
26412309
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.
Results Reference
background
PubMed Identifier
25728756
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.
Results Reference
background
PubMed Identifier
15642526
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.
Results Reference
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LINQ for impEdance meAsuremeNt While Off From HF Medication Study

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