Pancreatic exocrine insufficiency in heart failure
Completed
- Conditions
- Heart failure1001928010003018
- Registration Number
- NL-OMON50432
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
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
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The prevalence of EPI (defined as FE-1 <200 µg/g) in the advanced HF population<br /><br>compared to controls with mild HF</p><br>
- Secondary Outcome Measures
Name Time Method <p>• The association between FE-1 results and natriuretic peptides (NT-proBNP)<br /><br>• The association between FE-1 results and patient-reported outcome related to<br /><br>HF<br /><br>• The association between FE-1 results and vitamin status<br /><br>• The association between FE-1 results and patient-reported outcome related to<br /><br>loss of appetite/malnutrition<br /><br>• The association between FE-1 results and the prevalence of significant<br /><br>weight-loss (defined as loss of >5% body weight the past 6 months) </p><br>