Pancreatic exocrine functioning after cardiac resynchronization therapy

Pancreatic exocrine functioning after cardiac resynchronization therapy - PEX-CRT

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON50583

Enrollment

Registered

2022-02-01

Start date

2022-02-01

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart failure

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
The change in FE-1 results and markers of nutritional status at baseline and 6-months after CRT implantation	—

Secondary

Measure	Time frame
1. The (change in) FE-1 results between CRT responders and non-responders 2. The difference in prevalence of exocrine pancreatic insufficiency (defined as FE-1	—

Countries

Netherlands

Outcome results