Cardiac Cachexia in Advanced Heart Failure

NCT06259045 | Active Not Recruiting

• 1 other identifier: 334613
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Advanced Heart Failure; Cardiac Cachexia; Weight Loss

Keywords

Advanced heart failure; Cardiac cachexia; Heart failure; Unintentional weight loss; Frailty; Sarcopaenia; Cachexia

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Secondary Outcomes (8)

• Hospitalisation secondary to heart failure

  12 months

• New ventricular arrhythmogenesis

  12 months

• New stroke

  12 months

• New myocardial Infarction

  12 months

• Cardiovascular death

  12 months

Study Arms (1)

Advanced heart failure

Patients enrolled will all have advanced heart failure, defined by a set criteria

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with advanced heart failure are being recruited in to this study

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Royal Brompton & Harefield NHS Foundation Trust: lead

Study Sites (1)

Harefield Hospital

London, UB96JH, United Kingdom

Location

MeSH Terms

Conditions

Weight Loss; Heart Failure; Frailty; Cachexia

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Thinness

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2024
• First Posted: February 14, 2024
• Study Start: January 25, 2024
• Primary Completion: September 1, 2025
• Study Completion: November 1, 2025
• Last Updated: February 14, 2024

Record last verified: 2024-02

Locations

GB (1)