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

June 19, 2018 updated by: Medtronic BRC
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NON_RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Diuretic Suspension (DS)
Drug: Diuretic Suspension (DS)
Stop diuretic consumption in the 48h before the follow-up visit
EXPERIMENTAL: Diuretic Increase (DI)
Drug: Diuretic Increase (DI)
Double diuretics dosage in the 48h before the follow-up visit
EXPERIMENTAL: Diuretic and Medication Suspension (DMS)
Drug: Diuretic and Medication Suspension (DMS)
Stop diuretic and MRA medication consumption in the 48h before the follow-up visit

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Derived-subcutaneous impedance
Time Frame: 2 months
The variation of impedance magnitude and the time of occurrence after medication regimen changes will be detected by the LINQ ICM
2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Adverse Events
Time Frame: 6 months
All AEs related to changes in the therapeutic regimen and/or to HF status will be collected through CRF completion
6 months
Number of Transitory Arrhythmias
Time Frame: 6 months
Any transitory arrhythmias related to drug regimen changes and/or HF condition will be collected through CRF completion
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic BRC

Investigators

  • Study Chair: John Cleland, Prof, NHS Greater Glasgow & Clyde

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 30, 2017

Primary Completion (ANTICIPATED)

January 1, 2019

Study Completion (ANTICIPATED)

April 1, 2019

Study Registration Dates

First Submitted

July 7, 2017

First Submitted That Met QC Criteria

August 9, 2017

First Posted (ACTUAL)

August 10, 2017

Study Record Updates

Last Update Posted (ACTUAL)

June 21, 2018

Last Update Submitted That Met QC Criteria

June 19, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MDT16014

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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