Pancreatic exocrine functioning after cardiac resynchronization therapy
- Conditions
- Heart failure1001928010003018
- Registration Number
- NL-OMON50583
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 60
Inclusion Criteria
(1) age >= 18 years
(2) accepted for de novo transvenous CRT-(D/P) implantation at the UMCG for
chronic heart failure
(3) give written informed consent
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 non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The change in FE-1 results and markers of nutritional status at baseline and<br /><br>6-months after CRT implantation</p><br>
- Secondary Outcome Measures
Name Time Method <p>1. The (change in) FE-1 results between CRT responders and non-responders<br /><br>2. The difference in prevalence of exocrine pancreatic insufficiency (defined<br /><br>as FE-1<200 pg/g) between CRT responders and non-responders<br /><br>3. The association between exocrine pancreatic insufficiency (defined as FE-1<br /><br><200 pg/g) at baseline and response to CRT<br /><br>4. The association between the degree of response (change in LVESV) and change<br /><br>in FE-1</p><br>