NAFLD; Hypertension, White-coat Hypertension, Masked Hypertension Clinical Trial
— HyperNAFLDOfficial title:
24-h-ambulatory Blood Pressure Monitoring (24-h-ABPM) and Pulse Wave Analysis (PWA) in Patients With Non-alcoholic Fatty Liver Disease (NAFLD) to Evaluate the Individual Cardiovascular Risk Profile.
NCT number | NCT04543721 |
Other study ID # | 20-1048 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | October 1, 2019 |
Est. completion date | December 31, 2022 |
Verified date | September 2020 |
Source | University Hospital of Cologne |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Evaluation of the individual cardiovascular risk profile of patients with non-alcoholic fatty liver disease (NAFLD) using 24-hour ambulatory long-term blood pressure measurement and pulse wave analysis
Status | Recruiting |
Enrollment | 200 |
Est. completion date | December 31, 2022 |
Est. primary completion date | December 31, 2021 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility |
Inclusion Criteria: - = 18 years - Patients with confirmed or newly diagnosed non-alcoholic fatty liver disease (NAFLD),NAFL,NASH - Patients with arterial hypertension, without concomitant liver disease - Patients with overweight or obesity (BMI =25) without fatty liver; the latter excluded in advance by current imaging - Patients with chronic hepatitis B, chronic hepatitis C, ethyltoxic liver disease, autoimmune hepatitis, cholestatic liver disease (PBC, PSC) or other chronic hepatopathy; existing liver histology is desirable, but absence is not a criterion for exclusion All patients should be of normal weight (BMI 18.5 - 24.9) and, with the exception of alcoholic liver disease, should not have fatty liver in the imaging. - Patients with chronic inflammatory bowel disease (Crohn's disease, ulcerative colitis, colitis indeterminata) - Healthy controls: no known previous illness, no permanent medication, no fatty liver (excluded in advance by current imaging), normal weight (BMI 18.5 - 24.9). - Present declaration of consent Exclusion Criteria: - Failure to meet the inclusion criteria - A known chronic liver disease that is not described in the above mentioned collectives - Taking drugs that can cause fatty degeneration of the liver (e.g. methotrexate, amiodarone, tamoxifen, etc.) - Circumstances that do not allow the person concerned to assess the nature and extent as well as possible consequences of the clinical trial - Indications that the subject is unlikely to comply with the protocol (e.g., lack of cooperation) |
Country | Name | City | State |
---|---|---|---|
Germany | University Hospital of Cologne, Clinic for Gastroenterology and Hepatology | Cologne |
Lead Sponsor | Collaborator |
---|---|
University Hospital of Cologne |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Diagnosis of hypertension | Diagnosis of Hypertension and associated subtypes | 2019-2022 | |
Primary | Measurmement of pulsative hemodynamics | Measurmement of pulsative hemodynamics | 2019-2022 |