Pancreatic exocrine insufficiency in heart failure

Pancreatic exocrine insufficiency in heart failure - PEXI-HF

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON50432

Enrollment

Registered

2021-11-29

Start date

2022-02-15

Completion date

Unknown

Last updated

2024-06-18

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) 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

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 prevalence of EPI (defined as FE-1	—

Secondary

Measure	Time frame
• 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)	—

Measure

Time frame

• 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)

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Countries

Netherlands

Outcome results