Primary Objective: The primary objective of this study is to investigate the prevalence EPI in the advanced HF population Secondary Objectives: • To determine the association between exocrine pancreatic function and markers of HF• To determine the…
ID
Source
Brief title
Condition
- Heart failures
- Appetite and general nutritional disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The prevalence of EPI (defined as FE-1 <200 µg/g) in the advanced HF population
compared to controls with mild HF
Secondary outcome
• The association between FE-1 results and natriuretic peptides (NT-proBNP)
• The association between FE-1 results and patient-reported outcome related to
HF
• The association between FE-1 results and vitamin status
• The association between FE-1 results and patient-reported outcome related to
loss of appetite/malnutrition
• The association between FE-1 results and the prevalence of significant
weight-loss (defined as loss of >5% body weight the past 6 months)
Background summary
Heart failure (HF) is a complex clinical syndrome resulting from any functional
or structural heart disorder, impairing ventricular filling or ejection of
blood to the systemic circulation to meet the systemic needs [1,2].
Hemodynamically this results in congestion and/or hypoperfusion, and a
widespread neurohormonal and inflammatory response. Ultimately this leads to
impairment and/or failure of target organs, of which the kidney [3,4], liver
[5,6], brain [7,8] and intestines [6,9,10] have been widely studied. The
influence of these hemodynamic perturbations on the pancreas, however, has not
been well documented. This is striking, given the high degree of congestion in
the abdominal compartment [11], the susceptibility of the pancreas to ischemia
[12-15] and increased venous pressures [12] and the prevalence of malnutrition
and appetite loss among the (advanced) HF population.
The pancreas is principally an exocrine gland, responsible for discharging
digestive enzymes and bicarbonate into a system of intercalated ducts emptying
into the proximal duodenum. There seems to be an age-dependent decline in
exocrine pancreatic parenchyma, which is likely related to decreased perfusion
[16]. Although studies are scarce, HF also seems to lead to exocrine pancreatic
insufficiency (EPI) [13,17]. EPI results in maldigestion and malnutrition,
which in patients with (advanced) HF, could aggravate the development and
consequences of cardiac cachexia, a hallmark and strong independent prognostic
factor [18-20]. Unfortunately, no studies on the prevalence and consequences of
EPI in the advanced HF population, who are most susceptible to pancreatic
injury and cardiac cachexia, exist.
It is hypothesized HF is associated with pancreatic congestion leading to
exocrine pancreatic insufficiency (EPI) and this in turn contributes to loss of
appetite and the syndrome of cardiac cachexia [21]. The aim of this study is to
investigate EPI in the HF population and to determine its association with
markers of congestion and appetite loss. The results would increase our
understanding of HF-related target organ impairment and contribute to therapies
such as dietary intervention or pancreatic enzyme supplementation in the HF
population.
Study objective
Primary Objective:
The primary objective of this study is to investigate the prevalence EPI in the
advanced HF population
Secondary Objectives:
• To determine the association between exocrine pancreatic function and markers
of HF
• To determine the association between exocrine pancreatic function and
patient-reported outcome related to HF
• To determine the association between exocrine pancreatic function and vitamin
status
• To determine the association between exocrine pancreatic function and loss of
appetite
• To determine the association between exocrine pancreatic function and the
prevalence of weight-loss
Study design
The current study is a single center, cross-sectional, case-control
observational study. A total of 30 patients diagnosed with chronic advanced HF
at the University Medical Center Groningen (UMCG) cardiology department will be
recruited. These patients are matched for sex and age with 30 controls with
mild HF. This study will be performed at the outpatient clinic and the wards of
the UMCG department of cardiology.
Study burden and risks
Participants are burdened with additional blood sampling through vena puncture.
Additionally, participants are burdened with non-invasive fecal sampling and
testing and administration of patient-reported outcome measures.
There are no significant risks associated with this study.
Hanzeplein 1
Groningen 9700RB
NL
Hanzeplein 1
Groningen 9700RB
NL
Listed location countries
Age
Inclusion criteria
(1) age >= 18 years
(2) give written informed consent
(3) the Heart failure group must fulfil the ESC criteria for advanced heart
failure. In the control group heart failure must be considered mild (NYHA class
I/II, AHA stage C)
Exclusion criteria
(1) pancreatic diseases, including acute pancreatitis, chronic pancreatitis and
pancreatic cancer
(2) chronic liver disease and/or severe liver dysfunction with ASAT and/or ALAT
> 3x the upper limit of normal (ULN)
(3) congenital metabolic disease
(4) cystic fibrosis
(5) inflammatory bowel disease
(6) irritable bowel disease
(7) history of gastric bypass surgery
(8) pregnancy
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL78998.042.21 |