Advanced Heart FailureCACH-IT-AHFNCT06259045
Cardiac Cachexia in Advanced Heart Failure
An observational study of Advanced Heart Failure and Cardiac Cachexia, run by Royal Brompton & Harefield NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Heart failure is a condition in which the heart stops pumping effectively, causing symptoms such as breathlessness or leg swelling. It affects around 900,000 people in the United Kingdom. As our population gets older, this number will continue rise. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Heart Failure, Cardiac Cachexia, Weight Loss
- How many people
- 261 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 25 Feb 2024to 1 Apr 2026
- Phase
- Observational
- 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
Study population: Patients with advanced heart failure are being recruited in to this study
Who may be able to join
- Meets one of the "I NEED HELP" markers for advanced heart failure
- Has capacity to consent and participate in the study
- Age 18 years and older
Who cannot join
- Does not have at least one "I NEED HELP" marker for advanced heart failure
- Does not consent to or has not got the ability to participate in the study
- Is below the age of 18 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cardiac Cachexia in Advanced Heart Failure - a Prospective Cohort Study Investigating Prevalence and Outcome
Heart failure is a condition in which the heart stops pumping effectively, causing symptoms such as breathlessness or leg swelling. It affects around 900,000 people in the United Kingdom. As our population gets older, this number will continue rise. It is a condition with poor overall survival - nearly 50% of patients die within 5 years of being diagnosed with heart failure.
Cardiac cachexia is a complex condition associated with heart failure. There is general loss of muscle with or without loss of fat in cardiac cachexia. The main feature of cardiac cachexia is therefore unintentional weight loss in heart failure patients. The reason why it develops is poorly understood currently. Importantly, some studies have shown that cardiac cachexia is more likely to lead to poorer outcomes (such as death) in the patients who develop it.
Read more
However, there have been no studies, to our knowledge, that look at this condition in those patients who have very weak hearts ('advanced heart failure').
The investigators are looking to clarify how common cardiac cachexia is within advanced heart failure patients, and secondly how outcomes compare to those advanced heart failure patients that do not have the condition. With this in mind, the investigators will be able to establish the fuller impact cardiac cachexia has on survival and outcomes in patients with advanced heart failure. This study will involve assessing a group of ~200 advanced heart failure patients for cardiac cachexia to establish an estimate of how common it is overall. The investigators will then follow up the patients over a year, to see if we can assess the impact of cardiac cachexia on survival and outcomes.
Overall, the investigators therefore hope this study will give a more robust picture on the true impact of cardiac cachexia in advanced heart failure. By doing so, the investigators will firstly highlight its importance to other clinicians who will better be able to monitor and or diagnose it, and secondly pave way for more research on a potential treatment strategy for this condition.
Read the detailed description
Cardiac cachexia (CC) is a complex metabolic syndrome associated with chronic heart failure, characterised by loss of muscle with or without loss of fat. The prominent clinical feature of CC is unintentional weight loss in adults. Anorexia, inflammation, insulin resistance and increased muscle protein breakdown are frequently associated with wasting disease. Cachexia is associated with increased morbidity, is infrequently identified or diagnosed and rarely treated. Using an older definition of CC, previous studies have found its presence to confer a poorer overall prognosis (50% mortality at 18 months follow-up in a cohort of general heart failure patients). Depending on the definition used, the prevalence of CC in heart failure has been described in literature as anywhere between 10 - 37%. The pathogenesis of CC is poorly understood, but is likely to be multi factorial, driven by a low cardiac output resulting in an increase in catabolic versus anabolic metabolism.
A consensus definition from 2008 now states that CC is present when a patient has non-oedematous weight loss of at least 5% in ⩽12 months or body mass index <20 kg/m2, plus three out of five other criteria including: (i) Decreased muscle strength (ii) Fatigue (iii) Anorexia (iv) Low fat-free mass index (v) Abnormal biochemistry e.g. Increased inflammatory markers (C-reactive protein, interleukin-6), anaemia, or low serum albumin.
The prevalence of CC in advanced heart failure (AHF), however, has not been described. In this cohort of patients, independent prognosticators are vitally important given the overall propensity towards deterioration and morality. AHF refers to those patients at the end of the clinical spectrum of heart failure. There are a number of criteria to identify patients with AHF, one of which being the 'I NEED HELP' criteria.
The investigators hypothesise that the prevalence of CC in AHF confers a poorer prognosis when compared to the general heart failure population. By establishing its true prevalence and prognostic impact in AHF, the group aim to highlight the need to diagnose cardiac cachexia in AHF earlier, so patients can undergo the appropriate level of closer monitoring and/or escalation in terms of potential invasive therapies or cardiac transplantation where appropriate.
This study will involve participants with AHF being recruited from a single tertiary cardiac centre, via both inpatient and outpatient settings. Participants will be assessed for CC using the aforementioned 2008 CC criteria. After study enrollment, eligible participants will undergo follow up over 12 months'. This will allow the investigators to evaluate the prevalence and 12-month prognosis of cardiac cachexia in an advanced heart failure population in a hospital setting.
- Conditions
- Advanced Heart Failure, Cardiac Cachexia, Weight Loss
- Keywords
- Advanced heart failure, Cardiac cachexia, Heart failure, Unintentional weight loss, Frailty, Sarcopaenia, Cachexia
- Medical subject headings
- Weight Loss, Heart Failure, Frailty, Cachexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Advanced heart failure | Patients enrolled will all have advanced heart failure, defined by a set criteria |
What is being measured
The primary outcome is the main question the study is designed to answer.
Combined composite primary end point of: all-cause mortality or cardiac transplantation or left ventricular assist device (LVAD) insertion
This combined composite primary end-point will assess for multiple adverse outcomes within our cohort, which will be assessed for and combined to form this single primary end point. If the participants were to: die due to any cause, undergo cardiac transplantation or LVAD insertion over the 12 month follow-up period, then the primary end-point will have been reached. Comparisons will be made between participants with and without cardiac cachexia in our cohort.
Measured: 12 months
Secondary outcomes (8)
Hospitalisation secondary to heart failure
If participants were hospitalised secondary to heart failure causes over the 12 month follow up period, they will have reached this end-point. Comparisons will be made between patients with and without cardiac cachexia in our cohort.
Measured: 12 months
New ventricular arrhythmogenesis
If participants develop any ventricular arrhythmia over the 12 month follow up period, they will have reached this end-point. Comparisons will be made between participants with and without cardiac cachexia in our cohort.
Measured: 12 months
New stroke
If participants develop a stroke within the 12 month follow up period, they will have reached this end-point. Comparisons will be made between participants with and without cardiac cachexia in our cohort.
Measured: 12 months
New myocardial Infarction
If participants develop a myocardial infarction within the 12 month follow up period, they will have reached this end-point. Comparisons will be made between participants with and without cardiac cachexia in our cohort.
Measured: 12 months
Cardiovascular death
If participants die secondary to a cardiovascular cause within the 12 month follow up period, they will have reached this end-point. Comparisons will be made between participants with and without cardiac cachexia in our cohort.
Measured: 12 months
Hospitalisation (all-cause)
If participants were hospitalised for any reason over the 12 month follow up period, they will have reached this end-point. Comparisons will be made between patients with and without cardiac cachexia in our cohort.
Measured: 12 months
Changes to quality of lifestyle questionnaire KCCQ-12
Changes to the Kansas city cardiomyopathy Questionnaire-12 (KCCQ-12) score from baseline to 12 months will be assessed. Comparisons will be made between patients with and without cardiac cachexia in our cohort.
Measured: 12 months
Changes to quality of lifestyle questionnaire MLWHFQ
Changes to the Minnesota Living with Heart Failure Questionnaire (MLWHFQ) score from baseline to 12 months will be assessed. Comparisons will be made between patients with and without cardiac cachexia in our cohort.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2024
- Study start25 Feb 2024
- Primary completion25 Feb 2026
- Study completion1 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 261 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06259045
- Sponsor's protocol ID
- 334613
- Acronym
- CACH-IT-AHF
- Status last verified
- Jun 2026
- First submitted
- 26 Jan 2024
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: TBC
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Cachexia in Advanced Heart Failure - a Prospective Cohort Study Investigating Prevalence and Outcome
- ClinicalTrials.gov ID
- NCT06259045
- Acronym / sponsor ID
- CACH-IT-AHF / 334613
- Conditions
- Advanced Heart Failure, Cardiac Cachexia, Weight Loss
- Keywords
- Advanced heart failure, Cardiac cachexia, Heart failure, Unintentional weight loss, Frailty, Sarcopaenia, Cachexia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 261 participants (actual)
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation TrustUniversity, hospital or other
- Study start
- 25 Feb 2024 (actual)
- Primary completion
- 25 Feb 2026 (actual)
- Study completion
- 1 Apr 2026 (actual)
- First posted
- 14 Feb 2024 (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.
Heart failure is a condition in which the heart stops pumping effectively, causing symptoms such as breathlessness or leg swelling. It affects around 900,000 people in the United Kingdom. As our population gets older, this number will continue rise. It is a condition with poor overall survival - nearly 50% of patients die within 5 years of being diagnosed with heart failure.
Cardiac cachexia is a complex condition associated with heart failure. There is general loss of muscle with or without loss of fat in cardiac cachexia. The main feature of cardiac cachexia is therefore unintentional weight loss in heart failure patients. The reason why it develops is poorly understood currently. Importantly, some studies have shown that cardiac cachexia is more likely to lead to poorer outcomes (such as death) in the patients who develop it.
However, there have been no studies, to our knowledge, that look at this condition in those patients who have very weak hearts ('advanced heart failure').
The investigators are looking to clarify how common cardiac cachexia is within advanced heart failure patients, and secondly how outcomes compare to those advanced heart failure patients that do not have the condition. With this in mind, the investigators will be able to establish the fuller impact cardiac cachexia has on survival and outcomes in patients with advanced heart failure. This study will involve assessing a group of ~200 advanced heart failure patients for cardiac cachexia to establish an estimate of how common it is overall. The investigators will then follow up the patients over a year, to see if we can assess the impact of cardiac cachexia on survival and outcomes.
Overall, the investigators therefore hope this study will give a more robust picture on the true impact of cardiac cachexia in advanced heart failure. By doing so, the investigators will firstly highlight its importance to other clinicians who will better be able to monitor and or diagnose it, and secondly pave way for more research on a potential treatment strategy for this condition.
Detailed description
Cardiac cachexia (CC) is a complex metabolic syndrome associated with chronic heart failure, characterised by loss of muscle with or without loss of fat. The prominent clinical feature of CC is unintentional weight loss in adults. Anorexia, inflammation, insulin resistance and increased muscle protein breakdown are frequently associated with wasting disease. Cachexia is associated with increased morbidity, is infrequently identified or diagnosed and rarely treated. Using an older definition of CC, previous studies have found its presence to confer a poorer overall prognosis (50% mortality at 18 months follow-up in a cohort of general heart failure patients). Depending on the definition used, the prevalence of CC in heart failure has been described in literature as anywhere between 10 - 37%. The pathogenesis of CC is poorly understood, but is likely to be multi factorial, driven by a low cardiac output resulting in an increase in catabolic versus anabolic metabolism.
A consensus definition from 2008 now states that CC is present when a patient has non-oedematous weight loss of at least 5% in ⩽12 months or body mass index <20 kg/m2, plus three out of five other criteria including: (i) Decreased muscle strength (ii) Fatigue (iii) Anorexia (iv) Low fat-free mass index (v) Abnormal biochemistry e.g. Increased inflammatory markers (C-reactive protein, interleukin-6), anaemia, or low serum albumin.
The prevalence of CC in advanced heart failure (AHF), however, has not been described. In this cohort of patients, independent prognosticators are vitally important given the overall propensity towards deterioration and morality. AHF refers to those patients at the end of the clinical spectrum of heart failure. There are a number of criteria to identify patients with AHF, one of which being the 'I NEED HELP' criteria.
The investigators hypothesise that the prevalence of CC in AHF confers a poorer prognosis when compared to the general heart failure population. By establishing its true prevalence and prognostic impact in AHF, the group aim to highlight the need to diagnose cardiac cachexia in AHF earlier, so patients can undergo the appropriate level of closer monitoring and/or escalation in terms of potential invasive therapies or cardiac transplantation where appropriate.
This study will involve participants with AHF being recruited from a single tertiary cardiac centre, via both inpatient and outpatient settings. Participants will be assessed for CC using the aforementioned 2008 CC criteria. After study enrollment, eligible participants will undergo follow up over 12 months'. This will allow the investigators to evaluate the prevalence and 12-month prognosis of cardiac cachexia in an advanced heart failure population in a hospital setting.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Advanced heart failure | – | –Patients enrolled will all have advanced heart failure, defined by a set criteria |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with advanced heart failure are being recruited in to this study
Key inclusion criteria (3 listed)
- Meets one of the "I NEED HELP" markers for advanced heart failure
- Has capacity to consent and participate in the study
- Age 18 years and older
Key exclusion criteria (3 listed)
- Does not have at least one "I NEED HELP" marker for advanced heart failure
- Does not consent to or has not got the ability to participate in the study
- Is below the age of 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Combined composite primary end point of: all-cause mortality or cardiac transplantation or left ventricular assist device (LVAD) insertion
Time frame: 12 months
This combined composite primary end-point will assess for multiple adverse outcomes within our cohort, which will be assessed for and combined to form this single primary end point. If the participants were to: die due to any cause, undergo cardiac transplantation or LVAD insertion over the 12 month follow-up period, then the primary end-point will have been reached. Comparisons will be made between participants with and without cardiac cachexia in our cohort.
8 secondary outcomes
Hospitalisation secondary to heart failure
Time frame: 12 months
New ventricular arrhythmogenesis
Time frame: 12 months
New stroke
Time frame: 12 months
New myocardial Infarction
Time frame: 12 months
Cardiovascular death
Time frame: 12 months
Hospitalisation (all-cause)
Time frame: 12 months
Changes to quality of lifestyle questionnaire KCCQ-12
Time frame: 12 months
Changes to quality of lifestyle questionnaire MLWHFQ
Time frame: 12 months
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 4 Jun 2026.
- Individual participant dataSharing planned: Undecided. TBC
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced Heart Failure and Cardiac Cachexia, run by Royal Brompton & Harefield NHS Foundation 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 3 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 4 Jun 2026. 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?
Combined composite primary end point of: all-cause mortality or cardiac transplantation or left ventricular assist device (LVAD) insertion (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Jun 2026.