NAFLDNCT06386094
Cardiac Dysfunction in Patients with Fatty Liver Disease
An observational study of NAFLD and Cardiac Disease, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
Trial summary
Cirrhotic cardiomyopathy is seen as a blunted contractile responsiveness to stress, and/or altered diastolic relaxation with electrophysiological abnormalities, in absence of known cardiac disease. Left ventricular diastolic dysfunction (LVDD) is associated with risk of hepatorenal syndrome (HRS) , septic shock. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- NAFLD, Cardiac Disease, Fatty Liver
- What is being tested?
- Echocardiographic assessment
- How many people
- 150 participants
- Where
- 1 siteIndia
- Study dates
- 15 Jul 2023to 15 Nov 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The target population for this study is all patients with a diagnosis of metabolic dysfunction associated steatotic liver disease seen in the outpatient and inpatient services of the Department of Hepatology, PGIMER Chandigarh.
Who may be able to join
- Age range of 18-65 years
- metabolic dysfunction associated steatotic liver disease as diagnosed either by histology or clinical, laboratory, non invasive tests, USG findings and vibration controlled transient elastography (VCTE).
Who cannot join
- Age >65 years
- Chronic renal disease
- Pregnancy and peripartum cardiomyopathy
- Hypertension
- Valvular heart disease
- Sick sinus syndrome/ Pacemaker
Show all 13Show fewer
- Cardiac rhythm disorder
- Hypothyroidism
- Hyperthyroidism
- Portal vein thrombosis
- Transjugular intrahepatic porto systemic shunt (TIPS) insertion
- Hepatocellular carcinoma
- Anemia Hb < 8gm/dl in females, and < 9 gm/dl in males at the time of assessment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site, 1 recruiting
- Recruiting
Dr. Madhumita Premkumar
Chandigarh, Chandigarh, 160012
Dr. Madhumita Premkumar, MD, +9101722754777, drmadhumitap@gmail.com
About this study
Official title: Cirrhotic Cardiomyopathy and Cardiac Dysfunction in Patients with Metabolic Dysfunction Associated Steatotic Liver Disease
Cirrhotic cardiomyopathy is seen as a blunted contractile responsiveness to stress, and/or altered diastolic relaxation with electrophysiological abnormalities, in absence of known cardiac disease. Left ventricular diastolic dysfunction (LVDD) is associated with risk of hepatorenal syndrome (HRS) , septic shock. , heart failure in the perioperative period following liver transplantation, and after trans-jugular intrahepatic portosystemic shunt (TIPS) insertion . The echocardiographic E/e' ratio is a predictor of survival in LVDD, with multiple studies, including prospective data from our Centre. The inability of the heart to cope with stress or sepsis induced circulatory failure is a key concept of the increased mortality risk due to LVDD. In view of the metabolic syndrome and diabetes epidemic and an increasing number of patients being diagnosed with non-alcoholic fatty liver disease, there is increased risk of developing cardiac dysfunction due to multiple comorbidities including coronary artery disease, hypertensive heart disease, cirrhotic cardiomyopathy, which are contributors to overall cardiovascular risk of mortality.
Read the detailed description
Nonalcoholic fatty liver disease (NAFLD) and heart failure (HF) are obesity-related conditions with high cardiovascular mortality. Many new studies have linked NAFLD to changes in myocardial energy metabolism, and to echocardiographic measurements of cardiac dysfunction especially heart failure with preserved ejection fraction. Cardiac dysfunction in NAFLD is related to the release of inflammatory cytokines among those with steatohepatitis (NASH). However composite models looking at coronary artery disease, systolic and diastolic heart failure and outcomes in patients with NAFLD are limited, and the few preliminary analyses of this relationship using histologically-defined NASH or lean NAFLD remain unclear.
In this project the investigators will screen patients with a diagnosis of 'non-alcoholic fatty liver disease' for presence of coronary artery disease, arrhythmias, cirrhotic cardiomyopathy and develop a model for cardiac dysfunction in such patients.
- Conditions
- NAFLD, Cardiac Disease, Fatty Liver, MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease
- Being tested
- Echocardiographic assessment
- Keywords
- MASLD, Cirrhotic Cardiomyopathy, Heart failure in Cirrhosis, Coronary Artery Disease
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Heart Diseases, Fatty Liver, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Echocardiographic assessmentDiagnostic test
M mode, cross sectional and pulsed wave Doppler Echocardiographic examinations will be performed using a with a 2.5 MHz wide angle phased array transducer. Patients will be laid in left lateral position and examined in standard parasternal long and short axis and apical views. Short axis recordings will be performed at the level of the papillary muscles. M mode tracings will be recorded at the level of the papillary muscles and the aortic valves, with 2 -D guidance. LV wall thickness and cavity diameters will be measured by M mode, through the largest diameter of the ventricle, if possible, both in diastole and systole. Using the cross-sectional images as a guide, the M mode tracing of the left ventricle will obtained to calculate measurements according to the recommendations of American Society of Echocardiography.
| Study group | Role | What they receive |
|---|---|---|
| MASLD | Non invasive tests like APRI, FIB-4, , FAST scan and VCTE in the form of Fibroscan will be done and recorded.
Liver biopsy would be done as per the clinical indication. Diagnosis of NAFLD will be based on history, physical examination, laboratory investigations, upper gastrointestinal endoscopy, imaging studies (ultrasonography and Doppler of spleno portal venous axis, VCTE) and liver biopsy where available. Receives: Diagnostic Test: Echocardiographic assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the prevalence of cardiac dysfunction in patients with non-alcoholic fatty liver disease/ metabolic dysfunction associated steatotic liver disease
Prevalence of CCM in the MASLD cohort
Measured: At Enrolment
Secondary outcomes (5)
Presence of myocardial abnormalities in CCM dysfunction
Use of cardiac MRI or CT
Measured: At Enrolment
Presence of perfusion abnormalities in CCM dysfunction
Use of LV scintigraphy
Measured: At Enrolment
All cause mortality in metabolic dysfunction associated steatotic liver disease
All cause mortality will be recorded
Measured: 12 months after enrolment
Cardiac event related mortality in MASLD
Cardiovascular events like incidence of arrhythmia, symptomatic heart failure related deaths will be recorded.
Measured: 12 months after enrolment
To determine the severity of cardiac dysfunction in patients with metabolic dysfunction associated steatotic liver disease
Prevalence of CCM in the MASLD cohort, and grade of LV diastolic and systolic dysfunction
Measured: At Enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2024
- Study start15 Jul 2023
- Primary completion15 Aug 2027 (estimated)
- Study completion15 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NAFLDStudies 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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Madhumita Premkumar, Post Graduate Institute of Medical Education and Research, Chandigarh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06386094
- Sponsor's protocol ID
- INT/IEC/2023/SPL-902
- Other IDs
- IEC/2024/1523 dt 3.12.2024
- Status last verified
- Jan 2025
- First submitted
- 19 Sep 2023
- Last updated
- 29 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Younossi ZM, Koenig AB, Abdelatif D, Fazel Y, Henry L, Wymer M. Global epidemiology of nonalcoholic fatty liver disease-Meta-analytic assessment of prevalence, incidence, and outcomes. Hepatology. 2016 Jul;64(1):73-84. doi: 10.1002/hep.28431. Epub 2016 Feb 22.
PubMed 26707365
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cirrhotic Cardiomyopathy and Cardiac Dysfunction in Patients with Metabolic Dysfunction Associated Steatotic Liver Disease
- ClinicalTrials.gov ID
- NCT06386094
- Acronym / sponsor ID
- INT/IEC/2023/SPL-902
- Conditions
- NAFLD, Cardiac Disease, Fatty Liver, MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease
- Keywords
- MASLD, Cirrhotic Cardiomyopathy, Heart failure in Cirrhosis, Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Study start
- 15 Jul 2023 (actual)
- Primary completion
- 15 Aug 2027 (estimated)
- Study completion
- 15 Nov 2027 (estimated)
- First posted
- 26 Apr 2024 (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.
Cirrhotic cardiomyopathy is seen as a blunted contractile responsiveness to stress, and/or altered diastolic relaxation with electrophysiological abnormalities, in absence of known cardiac disease. Left ventricular diastolic dysfunction (LVDD) is associated with risk of hepatorenal syndrome (HRS) , septic shock. , heart failure in the perioperative period following liver transplantation, and after trans-jugular intrahepatic portosystemic shunt (TIPS) insertion . The echocardiographic E/e' ratio is a predictor of survival in LVDD, with multiple studies, including prospective data from our Centre. The inability of the heart to cope with stress or sepsis induced circulatory failure is a key concept of the increased mortality risk due to LVDD. In view of the metabolic syndrome and diabetes epidemic and an increasing number of patients being diagnosed with non-alcoholic fatty liver disease, there is increased risk of developing cardiac dysfunction due to multiple comorbidities including coronary artery disease, hypertensive heart disease, cirrhotic cardiomyopathy, which are contributors to overall cardiovascular risk of mortality.
Detailed description
Nonalcoholic fatty liver disease (NAFLD) and heart failure (HF) are obesity-related conditions with high cardiovascular mortality. Many new studies have linked NAFLD to changes in myocardial energy metabolism, and to echocardiographic measurements of cardiac dysfunction especially heart failure with preserved ejection fraction. Cardiac dysfunction in NAFLD is related to the release of inflammatory cytokines among those with steatohepatitis (NASH). However composite models looking at coronary artery disease, systolic and diastolic heart failure and outcomes in patients with NAFLD are limited, and the few preliminary analyses of this relationship using histologically-defined NASH or lean NAFLD remain unclear.
In this project the investigators will screen patients with a diagnosis of 'non-alcoholic fatty liver disease' for presence of coronary artery disease, arrhythmias, cirrhotic cardiomyopathy and develop a model for cardiac dysfunction in such patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MASLD | – | Diagnostic Test: Echocardiographic assessmentNon invasive tests like APRI, FIB-4, , FAST scan and VCTE in the form of Fibroscan will be done and recorded. Liver biopsy would be done as per the clinical indication. Diagnosis of NAFLD will be based on history, physical examination, laboratory investigations, upper gastrointestinal endoscopy, imaging studies (ultrasonography and Doppler of spleno portal venous axis, VCTE) and liver biopsy where available. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The target population for this study is all patients with a diagnosis of metabolic dysfunction associated steatotic liver disease seen in the outpatient and inpatient services of the Department of Hepatology, PGIMER Chandigarh.
Key inclusion criteria (2 listed)
- Age range of 18-65 years
- metabolic dysfunction associated steatotic liver disease as diagnosed either by histology or clinical, laboratory, non invasive tests, USG findings and vibration controlled transient elastography (VCTE).
Key exclusion criteria (13 listed)
- Age >65 years
- Chronic renal disease
- Pregnancy and peripartum cardiomyopathy
- Hypertension
- Valvular heart disease
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 |
|---|---|---|
| Echocardiographic assessmentM mode, cross sectional and pulsed wave Doppler Echocardiographic examinations will be performed using a with a 2.5 MHz wide angle phased array transducer. Patients will be laid in left lateral position and examined in standard parasternal long and short axis and apical views. Short axis recordings will be performed at the level of the papillary muscles. M mode tracings will be recorded at the level of the papillary muscles and the aortic valves, with 2 -D guidance. LV wall thickness and cavity diameters will be measured by M mode, through the largest diameter of the ventricle, if possible, both in diastole and systole. Using the cross-sectional images as a guide, the M mode tracing of the left ventricle will obtained to calculate measurements according to the recommendations of American Society of Echocardiography. | Diagnostic test | MASLD |
Primary outcome
To determine the prevalence of cardiac dysfunction in patients with non-alcoholic fatty liver disease/ metabolic dysfunction associated steatotic liver disease
Time frame: At Enrolment
Prevalence of CCM in the MASLD cohort
5 secondary outcomes
Presence of myocardial abnormalities in CCM dysfunction
Time frame: At Enrolment
Presence of perfusion abnormalities in CCM dysfunction
Time frame: At Enrolment
All cause mortality in metabolic dysfunction associated steatotic liver disease
Time frame: 12 months after enrolment
Cardiac event related mortality in MASLD
Time frame: 12 months after enrolment
To determine the severity of cardiac dysfunction in patients with metabolic dysfunction associated steatotic liver disease
Time frame: At Enrolment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2025.
- Background: PubMed 26707365Younossi ZM, Koenig AB, Abdelatif D, Fazel Y, Henry L, Wymer M. Global epidemiology of nonalcoholic fatty liver disease-Meta-analytic assessment of prevalence, incidence, and outcomes. Hepatology. 2016 Jul;64(1):73-84. doi: 10.1002/hep.28431. Epub 2016 Feb 22.
- Individual participant dataSharing planned: Undecided
Related trials for NAFLD
Not yet recruitingPhase 2/3
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Not yet recruitingPhase 2
Qurse Revand for MASLD: A Randomized Controlled Safety and Efficacy Trial
MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease)
Not yet recruitingPhase 2/3
Evaluating the Safety and Efficacy of Roflumilast in the Treatment of Nonalcoholic Fatty Liver Disease Patients
NAFLD (Nonalcoholic Fatty Liver Disease)
Active, not recruitingObservational study
Non-Invasive MASLD Diagnosis & T2D Remission Biomarkers
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RecruitingPhase 2
Non-Alcoholic Fatty Liver Disease, the HEpatic Response to Oral Glucose, and the Effect of Semaglutide (NAFLD HEROES)
Non-Alcoholic Steatohepatitis, Non-Alcoholic Fatty Liver Disease
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.
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 and Cardiac Disease, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
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 2 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 29 Jan 2025. 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 India. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Madhumita Premkumar (01722754777, drmadhumitap@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the prevalence of cardiac dysfunction in patients with non-alcoholic fatty liver disease/ metabolic dysfunction associated steatotic liver disease (time frame: At Enrolment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06386094, which also lists 1 linked publication.
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 29 Jan 2025.