Heart FailureLIMIT-CHFNCT01320007
Lung Impedance Monitoring In Treatment of Chronic Heart Failure
A study testing Preset increase in frusemide dose in people with Heart Failure, run by Barts & The London NHS Trust at 1 site in United Kingdom.
Trial summary
Heart failure is a major clinical problem that is increasing in magnitude and the cost of management of heart failure is escalating. A significant part of this cost is related to unplanned acute presentation to emergency departments and hospitalisation with worsening shortness of breath due to increased fluid content… 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?
- Preset increase in frusemide dose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2010to Dec 2014
- Phase
- Interventional
- 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
- Previously fitted with an ICD or a CRT-D device for primary or secondary prevention (for at least 34 days) with a Medtronic Optivol capable Device
- Previous hospital admission for decompensated heart failure
- Left ventricular systolic dysfunction (EF <50%)
- Currently compensated heart failure with a functional class of III or better
- All patients will be on optimal medical treatment including a beta blocker, an ACEI (or ARB) and spironolactone unless contraindicated or not tolerated
Who cannot join
- Decompensated patients who have NYHA class IV or clinical signs of lung congestion at time of evaluation (these patients may be included later if/when their NYHA class improves)
- Patients with a high Optivol fluid index at time of evaluation (these patients may be included later when the Optivol fluid index comes down)
- Patients with advanced renal failure ± dialysis (Chronic Kidney Disease class 4 or 5 with an estimated GFR of <30 ml/min)
Trial locations and contacts
1 site in 1 country.
About this study
Heart failure is a major clinical problem that is increasing in magnitude and the cost of management of heart failure is escalating. A significant part of this cost is related to unplanned acute presentation to emergency departments and hospitalisation with worsening shortness of breath due to increased fluid content in the lungs.
Many heart failure patients are already fitted with defibrillators to protect them from the risk of fast heart rhythms and sudden death and are followed up in both the heart failure clinics and defibrillator clinics. Recently some of the defibrillators fitted have been equipped with an extra function that can detect and warn of changes in the fluid content of the lungs very early even before the patient starts to complain of any shortness of breath and before any signs of fluid overload are seen clinically. However, it is not known how to deal with these warnings if they occur very early and it is not known whether a medical intervention at his stage is beneficial to prevent progression and eventual hospital admission. In the majority of cases, early warnings of this kind are ignored or this function is disabled at implantation of the device.
The current study will involve patients who have already been fitted with a device with the above capability. The investigators will use the new function to guide management of these patients and compare their outcome with similar patients who are fitted with devices without it. The investigators will attempt to manage early warnings by a predetermined increase in medications in a group of patients and compare their clinical course to a similar group in whom no action is taken.
- Conditions
- Heart Failure
- Being tested
- Preset increase in frusemide dose, No intervention
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preset increase in frusemide doseDrug
All patients in Group 1 will have the Optivol function and alerts switched on. Optivol levels will be downloaded monthly via the Medtronic Carelink Network (for those patients who have it) or during pacemaker follow up appointments.
If the Optivol alarm goes off, all patients will be requested to contact a member of the research team by phone and those with rising Optivol (irrespective of the presence or absence of heart failure symptoms) will be requested to increase the dose of diuretic that they are on by 50% for 1 week then revert to their usual dose after 7 days. A routine renal function check will be performed at the end of the week.
No interventionOther
The Optivol data for these patients will be downloaded periodically (at each scheduled device check) and recorded but will not be available at follow up in the heart failure clinic.. These patients will act as controls for group 1 patients. They will undergo baseline investigations and then will undergo routine heart failure treatment and follow-up in the heart failure clinic. These will include a routine clinical evaluation, body weight and blood analysis as per the heart failure clinic protocol. Medications will be reviewed and changed according to clinical needs.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Optivol Group | Experimental | Not described Receives: Drug: Preset increase in frusemide dose |
| Group 2: Optivol alarm muted | Active comparator | Not described Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of unplanned hospitalisations or acute unscheduled care in the emergency department or heart failure clinic
The primary study end-point will be a comparison between groups 1 and 2 regarding the ratio of the number of readmissions for heart failure to the total number of patients in each group of the two main groups over the course of the study (i.e. number of readmissions per patient)
Measured: 1 year
Secondary outcomes (4)
NYHA functional Class improvement of at least 1 grade
The proportion of patients achieving at least 1 grade improvement in New York Heart Association functional class in each group
Measured: 1 year
Minnesota Quality of Life Score improvement in each group
A comparison between the 2 study groups regarding the magnitude of improvement in the Minnesota Living with Heart Failure (questionnaire) score at 1 year compared to baseline
Measured: 1 Year
Change in the 6 minute walk test(6MWT)distance in metres
A comparison between the change in the 6MWT distance covered (at 1 year compared to baseline) in each of the 2 study groups
Measured: 1 year
Change in the level of BNP in serum (pg/ml)
A comparison between between the 2 study groups regarding the change in level of BNP at 1 year compared to baseline
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2011 (estimated)
- Study startSep 2010
- Primary completionOct 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barts & The London NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard J Schilling, Md FRCP, Principal investigator, Barts and the London NHS Trust, Queen Mary University of London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01320007
- Sponsor's protocol ID
- BLT006957
- Acronym
- LIMIT-CHF
- Status last verified
- Feb 2015
- First submitted
- 21 Feb 2011
- Last updated
- 9 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Domenichini G, Rahneva T, Diab IG, Dhillon OS, Campbell NG, Finlay MC, Baker V, Hunter RJ, Earley MJ, Schilling RJ. The lung impedance monitoring in treatment of chronic heart failure (the LIMIT-CHF study). Europace. 2016 Mar;18(3):428-35. doi: 10.1093/europace/euv293. Epub 2015 Dec 18.
PubMed 26683599
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Impedance Monitoring In Treatment of Chronic Heart Failure
- ClinicalTrials.gov ID
- NCT01320007
- Acronym / sponsor ID
- LIMIT-CHF / BLT006957
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Barts & The London NHS TrustUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Oct 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 22 Mar 2011 (estimated)
- 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.
Heart failure is a major clinical problem that is increasing in magnitude and the cost of management of heart failure is escalating. A significant part of this cost is related to unplanned acute presentation to emergency departments and hospitalisation with worsening shortness of breath due to increased fluid content in the lungs.
Many heart failure patients are already fitted with defibrillators to protect them from the risk of fast heart rhythms and sudden death and are followed up in both the heart failure clinics and defibrillator clinics. Recently some of the defibrillators fitted have been equipped with an extra function that can detect and warn of changes in the fluid content of the lungs very early even before the patient starts to complain of any shortness of breath and before any signs of fluid overload are seen clinically. However, it is not known how to deal with these warnings if they occur very early and it is not known whether a medical intervention at his stage is beneficial to prevent progression and eventual hospital admission. In the majority of cases, early warnings of this kind are ignored or this function is disabled at implantation of the device.
The current study will involve patients who have already been fitted with a device with the above capability. The investigators will use the new function to guide management of these patients and compare their outcome with similar patients who are fitted with devices without it. The investigators will attempt to manage early warnings by a predetermined increase in medications in a group of patients and compare their clinical course to a similar group in whom no action is taken.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Optivol Group | Experimental | Drug: Preset increase in frusemide dose |
| Group 2: Optivol alarm muted | Active comparator | Other: No intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Previously fitted with an ICD or a CRT-D device for primary or secondary prevention (for at least 34 days) with a Medtronic Optivol capable Device
- Previous hospital admission for decompensated heart failure
- Left ventricular systolic dysfunction (EF <50%)
- Currently compensated heart failure with a functional class of III or better
- All patients will be on optimal medical treatment including a beta blocker, an ACEI (or ARB) and spironolactone unless contraindicated or not tolerated
Key exclusion criteria (3 listed)
- Decompensated patients who have NYHA class IV or clinical signs of lung congestion at time of evaluation (these patients may be included later if/when their NYHA class improves)
- Patients with a high Optivol fluid index at time of evaluation (these patients may be included later when the Optivol fluid index comes down)
- Patients with advanced renal failure ± dialysis (Chronic Kidney Disease class 4 or 5 with an estimated GFR of <30 ml/min)
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 |
|---|---|---|
| Preset increase in frusemide doseAll patients in Group 1 will have the Optivol function and alerts switched on. Optivol levels will be downloaded monthly via the Medtronic Carelink Network (for those patients who have it) or during pacemaker follow up appointments. If the Optivol alarm goes off, all patients will be requested to contact a member of the research team by phone and those with rising Optivol (irrespective of the presence or absence of heart failure symptoms) will be requested to increase the dose of diuretic that they are on by 50% for 1 week then revert to their usual dose after 7 days. A routine renal function check will be performed at the end of the week. | Drug | Group 1: Optivol Group |
| No interventionThe Optivol data for these patients will be downloaded periodically (at each scheduled device check) and recorded but will not be available at follow up in the heart failure clinic.. These patients will act as controls for group 1 patients. They will undergo baseline investigations and then will undergo routine heart failure treatment and follow-up in the heart failure clinic. These will include a routine clinical evaluation, body weight and blood analysis as per the heart failure clinic protocol. Medications will be reviewed and changed according to clinical needs. | Other | Group 2: Optivol alarm muted |
Primary outcome
The number of unplanned hospitalisations or acute unscheduled care in the emergency department or heart failure clinic
Time frame: 1 year
The primary study end-point will be a comparison between groups 1 and 2 regarding the ratio of the number of readmissions for heart failure to the total number of patients in each group of the two main groups over the course of the study (i.e. number of readmissions per patient)
4 secondary outcomes
NYHA functional Class improvement of at least 1 grade
Time frame: 1 year
Minnesota Quality of Life Score improvement in each group
Time frame: 1 Year
Change in the 6 minute walk test(6MWT)distance in metres
Time frame: 1 year
Change in the level of BNP in serum (pg/ml)
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2015.
- Derived from this study: PubMed 26683599Domenichini G, Rahneva T, Diab IG, Dhillon OS, Campbell NG, Finlay MC, Baker V, Hunter RJ, Earley MJ, Schilling RJ. The lung impedance monitoring in treatment of chronic heart failure (the LIMIT-CHF study). Europace. 2016 Mar;18(3):428-35. doi: 10.1093/europace/euv293. Epub 2015 Dec 18.
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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.
Richard J Schilling, Md FRCP principal investigator
Barts and the London NHS Trust, Queen Mary University of London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preset increase in frusemide dose in people with Heart Failure, run by Barts & The London NHS Trust 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 5 inclusion and 3 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: finished, as of the sponsor's last update on 9 Jul 2015. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of unplanned hospitalisations or acute unscheduled care in the emergency department or heart failure clinic (time frame: 1 year). 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 NCT01320007, which also lists 1 linked publication.
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 9 Jul 2015.