NCT03245281

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for phase_4 heart-failure

Timeline
Completed

Started Oct 2017

Shorter than P25 for phase_4 heart-failure

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 7, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 10, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

October 30, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

June 21, 2018

Status Verified

June 1, 2018

Enrollment Period

1.2 years

First QC Date

July 7, 2017

Last Update Submit

June 19, 2018

Conditions

Heart Failure

Keywords

Heart Failure

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Number of Adverse Events

    6 months

  • Number of Transitory Arrhythmias

    6 months

Study Arms (3)

Diuretic Suspension (DS)

EXPERIMENTAL
Drug: Diuretic Suspension (DS)

Diuretic Increase (DI)

EXPERIMENTAL
Drug: Diuretic Increase (DI)

Diuretic and Medication Suspension (DMS)

EXPERIMENTAL
Drug: Diuretic and Medication Suspension (DMS)

Interventions

Diuretic Suspension (DS)DRUG

Stop diuretic consumption in the 48h before the follow-up visit

Diuretic Suspension (DS)
Diuretic Increase (DI)DRUG

Double diuretics dosage in the 48h before the follow-up visit

Diuretic Increase (DI)
Diuretic and Medication Suspension (DMS)DRUG

Stop diuretic and MRA medication consumption in the 48h before the follow-up visit

Diuretic and Medication Suspension (DMS)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nhs Greater Glasgow & Clyde

Glasgow, G12 0XH, United Kingdom

RECRUITING

Related Publications (7)

  • 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.

    PMID: 18086926BACKGROUND

  • 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.

    PMID: 16079372BACKGROUND

  • 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.

    PMID: 15172409BACKGROUND

  • 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.

    PMID: 8117176BACKGROUND

  • 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.

    PMID: 26412309BACKGROUND

  • 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.

    PMID: 25728756BACKGROUND

  • 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.

    PMID: 15642526BACKGROUND

MeSH Terms

Conditions

Heart Failure

Interventions

Diuretics

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Natriuretic AgentsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and Uses

Study Officials

  • John Cleland, Prof

    NHS Greater Glasgow & Clyde

    STUDY CHAIR

Central Study Contacts

Teodora Bellone

CONTACT

433566566teodora.bellone@medtronic.com

Mirko De Melis

CONTACT

mirko.de.melis@medtronic.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2017

First Posted

August 10, 2017

Study Start

October 30, 2017

Primary Completion

January 1, 2019

Study Completion

April 1, 2019

Last Updated

June 21, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)