Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT06259045 |
| Other study ID # |
334613 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 25, 2024 |
| Est. completion date |
November 1, 2025 |
Study information
| Verified date |
February 2024 |
| Source |
Royal Brompton & Harefield NHS Foundation Trust |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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. 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.
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.
