NAFLD; Hypertension, White-coat Hypertension, Masked HypertensionHyperNAFLDNCT04543721
24-h-ambulatory Blood Pressure Monitoring and Pulse Wave Analysis in NAFLD Patients
An observational study of NAFLD; Hypertension, White-coat Hypertension, Masked Hypertension, run by University Hospital of Cologne at 1 site in Germany.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- NAFLD; Hypertension, White-coat Hypertension, Masked Hypertension
- What is being tested?
- 24-h-ABPM
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- 1 Oct 2019to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Adult, Older adult
Study population: Patients with confirmed or newly diagnosed NAFLD; NAFL; NASH * Patients with arterial hypertension, without concomitant liver disease * Patients with overweight or obesity (BMI ≥25) without fatty liver * Patients with chronic hepatitis B, chronic hepatitis C, alcoholic 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).
Who may be able to join
- ≥ 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Hospital of Cologne, Clinic for Gastroenterology and Hepatology
Cologne, 50937
Philipp Kasper, Dr., 0049-221-478-6002, Philipp.Kasper@uk-koeln.de
Anna Martin, Dr., 0049-221-478-6002, Anna.Martin@uk-koeln.de
About this study
Official 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.
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
Read the detailed description
Non-alcoholic fatty liver disease (NAFLD) is the most common chronic liver disease in western industrialized countries. Globally, but also in Germany, the current prevalence of NAFLD in the adult population is about 20-30% with a continuing upward trend.
The main cause of death in patients with NAFLD include cardiovascular events and the major risk factor for the occurrence of cardiovascular events is arterial hypertension.
Besides absolute systolic and diastolic blood pressure values, disturbances of circadian blood pressure variability seem to be of particular relevance for the occurrence of cardiovascular events.
24-hour ambulatory blood pressure monitoring (24-h-ABPM) has been established as the most reliable, non-invasive method to diagnose arterial hypertension. 24-h-ABPM complements office blood pressure measurement by the option of characterizing the circadian blood pressure profile and is superior to it in terms of predicting total mortality and cardiovascular mortality. Under- or overestimation of the actual blood pressure level during individual measurements in everyday clinical practice can be avoided by using 24-h-ABPM and special hypertension phenotypes such as white coat hypertension or masked hypertension can be identified.
In addition, modern 24-h-ABPM devices allow a simultaneous pulse wave analysis (PWA) to evaluate central hemodynamic parameters such as central aortic blood pressure, systolic blood pressure augmentation and pulse wave velocity. Using these functional parameters of pulsatile hemodynamics, it is possible to determine the extent of vascular damage and the cardiovascular risk of the individual patient much earlier and more precisely.
Although the epidemiological relationship between hypertension and cardiovascular morbidity and mortality in patients with NAFLD is well known, arterial hypertension and its special subtypes are still under- or misdiagnosed in this risk group or not sufficiently controlled when diagnosis has been established.
In this study we analyse the frequency of arterial hypertension and associated special subtypes (masked hypertension, white-coat hypertension) and altered functional hemodynamics in NAFLD patients using 24-h-ABPM and PWA. In addition we analyse serological biomarkerst to evaluate the individual cardiovascualr risk profile. Healthy persons without NAFLD as well as patients with other chronic liver diseases serve as controll and comparison group, respectiveley.
After successful characterization of the patient-specific cardiovascular risk profile, the development and establishment of a multimodal prevention program for NAFLD patients is planned. Central aspects of this interdisciplinary concept include counseling and guidance on lifestyle modifications (weight reduction, increase of physical activity, etc.) and optimization of the adjustment of cardiometabolic comorbidities (especially diabetes mellitus type 2, lipid metabolism disorders).
- Being tested
- 24-h-ABPM
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Hypertension, White Coat Hypertension, Masked Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
24-h-ABPMDevice
24-h- blood pressure measurement and pulse wave analysis
| Study group | Role | What they receive |
|---|---|---|
| 24-h-ABPM | Not described Receives: Device: 24-h-ABPM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis of hypertension
Diagnosis of Hypertension and associated subtypes
Measured: 2019-2022
Measurmement of pulsative hemodynamics
Measurmement of pulsative hemodynamics
Measured: 2019-2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2020
- Study start1 Oct 2019
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NAFLD; Hypertension, White-coat Hypertension, Masked HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital of Cologne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philipp Kasper, University Hospital of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04543721
- Sponsor's protocol ID
- 20-1048
- Acronym
- HyperNAFLD
- Status last verified
- Sep 2020
- First submitted
- 2 Sep 2020
- Last updated
- 10 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT04543721
- Acronym / sponsor ID
- HyperNAFLD / 20-1048
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital of CologneUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 10 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Non-alcoholic fatty liver disease (NAFLD) is the most common chronic liver disease in western industrialized countries. Globally, but also in Germany, the current prevalence of NAFLD in the adult population is about 20-30% with a continuing upward trend.
The main cause of death in patients with NAFLD include cardiovascular events and the major risk factor for the occurrence of cardiovascular events is arterial hypertension.
Besides absolute systolic and diastolic blood pressure values, disturbances of circadian blood pressure variability seem to be of particular relevance for the occurrence of cardiovascular events.
24-hour ambulatory blood pressure monitoring (24-h-ABPM) has been established as the most reliable, non-invasive method to diagnose arterial hypertension. 24-h-ABPM complements office blood pressure measurement by the option of characterizing the circadian blood pressure profile and is superior to it in terms of predicting total mortality and cardiovascular mortality. Under- or overestimation of the actual blood pressure level during individual measurements in everyday clinical practice can be avoided by using 24-h-ABPM and special hypertension phenotypes such as white coat hypertension or masked hypertension can be identified.
In addition, modern 24-h-ABPM devices allow a simultaneous pulse wave analysis (PWA) to evaluate central hemodynamic parameters such as central aortic blood pressure, systolic blood pressure augmentation and pulse wave velocity. Using these functional parameters of pulsatile hemodynamics, it is possible to determine the extent of vascular damage and the cardiovascular risk of the individual patient much earlier and more precisely.
Although the epidemiological relationship between hypertension and cardiovascular morbidity and mortality in patients with NAFLD is well known, arterial hypertension and its special subtypes are still under- or misdiagnosed in this risk group or not sufficiently controlled when diagnosis has been established.
In this study we analyse the frequency of arterial hypertension and associated special subtypes (masked hypertension, white-coat hypertension) and altered functional hemodynamics in NAFLD patients using 24-h-ABPM and PWA. In addition we analyse serological biomarkerst to evaluate the individual cardiovascualr risk profile. Healthy persons without NAFLD as well as patients with other chronic liver diseases serve as controll and comparison group, respectiveley.
After successful characterization of the patient-specific cardiovascular risk profile, the development and establishment of a multimodal prevention program for NAFLD patients is planned. Central aspects of this interdisciplinary concept include counseling and guidance on lifestyle modifications (weight reduction, increase of physical activity, etc.) and optimization of the adjustment of cardiometabolic comorbidities (especially diabetes mellitus type 2, lipid metabolism disorders).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 24-h-ABPM | – | Device: 24-h-ABPM |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with confirmed or newly diagnosed NAFLD; NAFL; NASH * Patients with arterial hypertension, without concomitant liver disease * Patients with overweight or obesity (BMI ≥25) without fatty liver * Patients with chronic hepatitis B, chronic hepatitis C, alcoholic 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).
Key inclusion criteria (8 listed)
- ≥ 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.
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 24-h-ABPM24-h- blood pressure measurement and pulse wave analysis | Device | 24-h-ABPM |
Primary outcome
Diagnosis of hypertension
Time frame: 2019-2022
Diagnosis of Hypertension and associated subtypes
Measurmement of pulsative hemodynamics
Time frame: 2019-2022
Measurmement of pulsative hemodynamics
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2020.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
University Hospital of Cologne, Clinic for Gastroenterology and Hepatology
Cologne, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of NAFLD; Hypertension, White-coat Hypertension, Masked Hypertension, run by University Hospital of Cologne at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosis of hypertension (time frame: 2019-2022). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2020.