Heart FailurePhase 4LEAN HFNCT03245281
LINQ for impEdance meAsuremeNt While Off From HF Medication Study
A Phase 4 study testing Diuretic Suspension (DS), Diuretic Increase (DI) and Diuretic and Medication Suspension (DMS) in people with Heart Failure, run by Medtronic BRC at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Diuretic Suspension (DS), Diuretic Increase (DI) and Diuretic and Medication Suspension (DMS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 Oct 2017to Apr 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Mirko De Melis contact
United Kingdom1 site, 1 recruiting
- Recruiting
Nhs Greater Glasgow & Clyde
Glasgow, G12 0XH
Clare Murphy, Dr, claremurphy4@nhs.net
About this study
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.
Read the 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.
- Conditions
- Heart Failure
- Being tested
- Diuretic Suspension (DS), Diuretic Increase (DI), Diuretic and Medication Suspension (DMS)
- Keywords
- Heart Failure
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diuretic Suspension (DS)Drug
Stop diuretic consumption in the 48h before the follow-up visit
Diuretic Increase (DI)Drug
Double diuretics dosage in the 48h before the follow-up visit
Diuretic and Medication Suspension (DMS)Drug
Stop diuretic and MRA medication consumption in the 48h before the follow-up visit
| Study group | Role | What they receive |
|---|---|---|
| Diuretic Suspension (DS) | Experimental | Not described Receives: Drug: Diuretic Suspension (DS) |
| Diuretic Increase (DI) | Experimental | Not described Receives: Drug: Diuretic Increase (DI) |
| Diuretic and Medication Suspension (DMS) | Experimental | Not described Receives: Drug: Diuretic and Medication Suspension (DMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Derived-subcutaneous impedance
The variation of impedance magnitude and the time of occurrence after medication regimen changes will be detected by the LINQ ICM
Measured: 2 months
Secondary outcomes (2)
Number of Adverse Events
All AEs related to changes in the therapeutic regimen and/or to HF status will be collected through CRF completion
Measured: 6 months
Number of Transitory Arrhythmias
Any transitory arrhythmias related to drug regimen changes and/or HF condition will be collected through CRF completion
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2017
- Study start30 Oct 2017
- Primary completionJan 2019 (estimated)
- Study completionApr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medtronic BRC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Cleland, Prof, Study chair, NHS Greater Glasgow and Clyde
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03245281
- Sponsor's protocol ID
- MDT16014
- Acronym
- LEAN HF
- Status last verified
- Jun 2018
- First submitted
- 7 Jul 2017
- Last updated
- 21 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 18086926Osterberg L, Blaschke T. Adherence to medication. N Engl J Med. 2005 Aug 4;353(5):487-97. doi: 10.1056/NEJMra050100. No abstract available.
PubMed 16079372Butler 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.
PubMed 15172409Monane 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.
PubMed 8117176Mittal 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.
PubMed 26412309Purerfellner 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.
PubMed 25728756van 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.
PubMed 15642526
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LINQ for impEdance meAsuremeNt While Off From HF Medication Study
- ClinicalTrials.gov ID
- NCT03245281
- Acronym / sponsor ID
- LEAN HF / MDT16014
- Conditions
- Heart Failure
- Keywords
- Heart Failure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Medtronic BRCIndustry (pharma, biotech, devices)
- Study start
- 30 Oct 2017 (actual)
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Apr 2019 (estimated)
- First posted
- 10 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diuretic Suspension (DS)Stop diuretic consumption in the 48h before the follow-up visit | Drug | Diuretic Suspension (DS) |
| Diuretic Increase (DI)Double diuretics dosage in the 48h before the follow-up visit | Drug | Diuretic Increase (DI) |
| Diuretic and Medication Suspension (DMS)Stop diuretic and MRA medication consumption in the 48h before the follow-up visit | Drug | Diuretic and Medication Suspension (DMS) |
Primary outcome
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 secondary outcomes
Number of Adverse Events
Time frame: 6 months
Number of Transitory Arrhythmias
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2018.
- Background: PubMed 18086926Rosamond 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.
- Background: PubMed 16079372Osterberg L, Blaschke T. Adherence to medication. N Engl J Med. 2005 Aug 4;353(5):487-97. doi: 10.1056/NEJMra050100. No abstract available.
- Background: PubMed 15172409Butler 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.
- Background: PubMed 8117176Monane 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.
- Background: PubMed 26412309Mittal 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.
- Background: PubMed 25728756Purerfellner 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.
- Background: PubMed 15642526van 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mirko De Melis contact
John Cleland, Prof study chair
NHS Greater Glasgow and Clyde
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Diuretic Suspension (DS), Diuretic Increase (DI) and Diuretic and Medication Suspension (DMS) in people with Heart Failure, run by Medtronic BRC at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Teodora Bellone (433566566 ext. 0031, teodora.bellone@medtronic.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Derived-subcutaneous impedance (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03245281, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2018.