LINQ for impEdance meAsuremeNt While Off From HF Medication Study

Heart Failure Clinical Trial

— LEAN HF  

Official title:

LINQ for impEdance meAsuremeNt While Off From HF Medication Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03245281
• Other study ID #: MDT16014
• Status: Recruiting
• Phase: Phase 4
• Start date: October 30, 2017
• Est. completion date: April 2019

Study information

• Verified date: June 2018
• Source: Medtronic BRC
• Contact: Teodora Bellone
• Phone: 433566566
• Email: teodora.bellone[@]medtronic.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: April 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Drug:
• 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

Locations

Country	Name	City	State
United Kingdom	Nhs Greater Glasgow & Clyde	Glasgow

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic BRC

Country where clinical trial is conducted

United Kingdom, 

References & Publications (7)

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. — View Citation

Mittal S, Sanders P, Pokushalov E, Dekker L, Kereiakes D, Schloss EJ, Pouliot E, Franco N, Zhong Y, DI Bacco M, Pürerfellner 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. — View 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. — View Citation

Osterberg L, Blaschke T. Adherence to medication. N Engl J Med. 2005 Aug 4;353(5):487-97. Review. — View Citation

Pürerfellner 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. — View 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. Epub 2007 Dec 17. Erratum in: Circulation. 2010 Jul 6;122(1):e10. Kissela, Bret [corrected to Kissela, Brett]. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Number of Transitory Arrhythmias	Any transitory arrhythmias related to drug regimen changes and/or HF condition will be collected through CRF completion	6 months