Heart DiseasesNCT06304233
The Protein Disrupted in Schizophrenia 1 (DISC1) as a Novel Biomarker for Cardiac Disease
An observational study of Heart Diseases and Heart; Functional Disturbance, run by Norwegian University of Science and Technology at 2 sites in Norway.
Trial summary
To study the association between DISC1 RNA expression levels and cardiac function in patients with schizophrenia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Heart Diseases, Heart; Functional Disturbance, Schizophrenia
- What is being tested?
- Echocardiography, Cardiac Magnetic Resonance Imaging and Electrocardiography
- How many people
- 120 participants
- Where
- 2 sitesNorway
- Study dates
- 13 Dec 2023to Jun 2038
- 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 cohort with schizophrenia will be recruited from outpatient and inpatient population from a single centre. The cohort without mental health diagnosis will be selected from an existing population registered in the HUNT data and biobank and be matched for age (± 2 years) and sex of the patients.
Who may be able to join
- Patients with ICD-10 schizophrenia, schizotypal or delusional disorders (F20 to F29)
- Both inpatient and outpatient
- Capable of giving informed consent
Who cannot join
- Current or previous diagnosis of cancer
- Current or previous treatment with chemotherapy
- Current pregnancy
- Mothers less than 6 months post-partum
Trial locations and contacts
2 sites in 1 country.
Norway2 sites
Norwegian University of Science and Technology
Trondheim
St Olavs Hospital, Trondheim University Hospital
Trondheim
About this study
Official title: The Protein Disrupted in Schizophrenia 1 (DISC1) as a Novel Biomarker for Cardiac Disease - The Link Between DISC1 and Cardiac Function in Patients With Schizophrenia
To study the association between DISC1 RNA expression levels and cardiac function in patients with schizophrenia.
Read the detailed description
Potential participants interested in the study will be screened for eligibility. Those who meet the eligibility criteria will be informed about the study, the expected investigations and its potential risks. All participants giving written informed consent will be enrolled into the study. Participants will be interviewed, given questionnaires, have blood and/or skin samples and clinical parameters taken. Cardiac function parameters will be measured using electrocardiography, echocardiography and magnetic resonance imaging.
- Conditions
- Heart Diseases, Heart; Functional Disturbance, Schizophrenia
- Being tested
- Echocardiography, Cardiac Magnetic Resonance Imaging, Electrocardiography, Blood sampling
- Keywords
- Disrupted in Schizophrenia 1, DISC1, Cardiac Biomarker
- Medical subject headings
- Heart Diseases, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchocardiographyDiagnostic test
Also called Echo
ultrasound assessment of heart structure, volume and function
Cardiac Magnetic Resonance ImagingDiagnostic test
Also called Cardiac MRI, CMRI
MRI assessment of heart structure, volume, function and tissue characteristics
ElectrocardiographyDiagnostic test
Also called Holter, ECG
Assessment of cardiac rhythm and electrical activity
Blood samplingOther
To measure DISC1 mRNA expression and other potential biomarkers
| Study group | Role | What they receive |
|---|---|---|
| Diagnosed with Schizophrenia | Patients with a ICD-10 diagnosis of Schizophrenia will undergo investigations to assess cardiac function, cardiovascular disease risk factors and DISC1 mRNA expression. Participants eligible for MRI will be invited to undergo cardiac MRI in addition to echocardiography. Receives: Diagnostic Test: Echocardiography; Diagnostic Test: Cardiac Magnetic Resonance Imaging; Diagnostic Test: Electrocardiography; Other: Blood sampling | |
| No mental health diagnosis | Participants without a mental health diagnosis will be randomly selected from an existing population registered in the HUNT data and biobank for whom, echocardiographic data and biological samples are available.Those enrolled as controls will be invited to participate in the cardiac MRI portion of the study. Receives: Diagnostic Test: Echocardiography; Diagnostic Test: Cardiac Magnetic Resonance Imaging; Diagnostic Test: Electrocardiography; Other: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left Ventricular Ejection Fraction (LVEF) measured by 2D Echocardiography
Left ventricular ejection fraction, LVEF will be reported in percentage (%) and obtained using Simpson's biplane method from 2D echocardiography.
Measured: Baseline
Left Ventricular Ejection Fraction (LVEF) measured by 3D Echocardiography
Left ventricular ejection fraction, LVEF will be reported in percentage (%) and obtained using 3D echocardiography
Measured: Baseline
DISC1 mRNA quantification
Measured from blood samples and reported as fold change
Measured: Baseline
Levels of high sensitive-CRP
Levels of HS-CRP mg/L
Measured: Baseline
Levels of CK-MB
Levels of CK-MB is reported in µg/L
Measured: Baseline
Levels of Troponin T
Levels of Troponin T is reported in ng/L
Measured: Baseline
Levels of Troponin I
Levels of Troponin I is reported in ng/L
Measured: Baseline
Normalized Left Ventricular End-Diastolic Volume (LV EDV), echocardiographic parameter
LV EDV in milliliters (mL) will be normalized against body surface area (BSA) in m^2 to report LV EDV normalized by BSA in mL/m^2.
Measured: Baseline
Normalized Right Ventricular End-Diastolic Volume (RV EDV), echocardiographic parameter
RV EDV in mL will be normalized against body surface area (BSA) in m^2 to report RV EDV normalized by BSA in mL/m^2.
Measured: Baseline
Normalized left Ventricular End-Systolic Volume (LV ESV), echocardiographic parameter
LV ESV in mL will be normalized against body surface area (BSA) in m^2 to report LV ESV normalized by BSA in mL/m^2.
Measured: Baseline
Normalized Right Ventricular End-Systolic Volume (RV ESV), echocardiographic parameter
RV ESV in mL will be normalized against body surface area (BSA) in m^2 to report RV ESV normalized by BSA in mL/m^2.
Measured: Baseline
Left ventricular mass measured by echocardiography
Left ventricular mass in grams (g) will be normalized against BSA in m^2 and reported as g/m ^2
Measured: Baseline
Left ventricular septal thickness, left ventricular posterior wall thickness and right ventricular wall thickness measured by echocardiography
Left ventricular septal thickness, left ventricular posterior wall thickness and right ventricular wall thickness will be reported in centimeters (cm)
Measured: Baseline
Fractional shortening measured by echocardiography
Fractional shortening will be reported as a percentage (%)
Measured: Baseline
Global longitudinal strain (GLS), echocardiographic parameter
GLS(%) = (MLs - MLd)/MLd, where MLs is myocardial length at end-systole and MLd is the myocardial length at end-diastole. GLS will be reported in precentage (%)
Measured: Baseline
TAPSE echocardiographic parameter of right ventricular longitudinal systolic function
TAPSE will be reported in millimeters (mm)
Measured: baseline
Echocardiographic parameter MPI, Myocardial performance index
MPI is a unitless index derived from the sum of the isovolumic relaxation time (IVRT) and the isovolumic contraction time (IVCT) in milliseconds (ms) divided by the ejection time interval in (ms).
Measured: Baseline
Echocardiographic parameter Mitral E/A ratio
Mitral E/A ratio is derived from the ratio of the E wave velocity to the A wave velocity
Measured: Baseline
Echocardiography parameter of peak E velocity
peak E velocity is reported in cm/s
Measured: Baseline
Echocardiography parameter of E wave deceleration time
E wave deceleration time is reported in milliseconds (ms)
Measured: Baseline
Echocardiography parameter of ratio of E/e'
The E/e' ratio is derived from the E wave velocity to the e' velocity
Measured: Baseline
Echocardiographic parameters septal e' and lateral e' velocities
Septal e' and lateral e' velocities are reported as cm/s
Measured: Baseline
Echocardiographic parameter LAVI, left atrial volume indexed
LAVI is reported in mL/m^2 and is the volume (mL) of the left atrium indexed against the BSA in m^2.
Measured: Baseline
Echocardiographic parameter TRpV, Tricuspid Regurgitation peak Velocity
TRpV is reported in m/s
Measured: Baseline
Echocardiographic parameter, S wave velocity
S wave velocity is the peak systolic velocity of the tricuspid annulus and is reported in cm/s
Measured: Baseline
Echocardiographic parameter, Indexed LV and RV stroke volumes
Indexed LV stroke volume and Indexed RV stroke volume will be reported in mL/m^2 by by indexing the volumes (mL) to BSA (m^2)
Measured: Baseline
Levels of NT-proBNP
Levels of NT-proBNP from blood samples will be reported in ng/L
Measured: Baseline
Levels of IGF1
Levels of IGF1 from blood samples will be reported in nmol/L
Measured: Baseline
Levels of ANP
Levels of ANP from blood samples will be reported in pg/mL
Measured: Baseline
Levels of BDNF, brain derived neurotrophic factor
Levels of BDNF from blood samples will be reported in ng/mL
Measured: Baseline
Levels of Tumor Necrosis Factor alpha
Levels of Tumor Necrosis Factor alpha from blood samples will be reported in pg/mL
Measured: Baseline
Levels of Transforming Growth Factor Beta
Levels of Transforming Growth Factor Beta from blood samples will be reported in ng/mL
Measured: Baseline
Levels of cardiac Myosin-Binding Protein C
Levels of cardiac Myosin-Binding Protein C from blood samples will be reported in ng/L
Measured: Baseline
Interleukin levels
Interleukin levels from blood sample will be reported as pg/mL
Measured: Baseline
Secondary outcomes (24)
native T1 time, cardiac MRI
native myocardial T1 relaxation time is reported in milliseconds (ms)
Measured: Baseline
Indexed LV and RV end-diastolic, end-systolic and stroke volumes, cardiac MRI
Indexed LV and RV end-diastolic, end-systolic and stroke volumes will be reported in mL/m^2, by indexing the volumes (mL) to BSA (m^2)
Measured: Baseline
Indexed LV mass, cardiac MRI
Indexed LV mass will be reported in g/m^2 by indexing mass (g) to BSA (m^2)
Measured: Baseline
LV Ejection Fraction, cardiac MRI
LVEF will be reported in percent (%)
Measured: Baseline
ECG corrected QT interval
corrected QT interval will be reported in milliseconds (ms)
Measured: Baseline
Number of participants with and abnormal ECG
Number of participants with an abnormal ECG will be reported in %
Measured: Baseline
Number of participants with abnormal liver function
Number of participants with abnormal liver function will be reported as %
Measured: Baseline
Number of participants with abnormal kidney function
Number of participants with abnormal kidney function will be reported as %
Measured: Baseline
Number of participants with abnormal thyroid function
Number of participants with abnormal thyroid function will be reported as %
Measured: Baseline
Number of participants with low Vitamin D levels
Number of participants with low Vitamin D levels will be reported as %
Measured: Baseline
Incidence of cardiovascular disease or mortality as registered in a health registry on follow up
Extraction of information from the cardiovascular disease registry and deaths registry between 10 - 15 years from the start of the study to determine incidence of cardiovascular disease outcomes for the study cohort
Measured: Within 15 years from start of study
Triglyceride levels
Triglyceride will be reported in mmol/L
Measured: Baseline
High-density lipoprotein, HDL-cholesterol levels
HDL-cholesterol levels will be reported in mmol/L
Measured: Baseline
Low-density lipoprotein, LDL-cholesterol levels
LDL-cholesterol levels will be reported in mmol/L
Measured: Baseline
Fasting glucose levels
Fasting glucose levels will be reported in mmol/L
Measured: Baseline
Glycated Hemoglobin (HbA1c) levels
HbA1C will be reported in mmol/mol
Measured: Baseline
Heart rate measured on ECG
Heart rate measured on 12 lead ECG will be reported in beats per minute.
Measured: Baseline
Systolic Blood Pressure
Systolic Blood Pressure will be reported as mmHg
Measured: Baseline
Diastolic Blood Pressure
Diastolic Blood Pressure will be reported as mmHg
Measured: Baseline
Lipoprotein a
Lipoprotein a levels will be reported in mg/L
Measured: Baseline
Magnesium levels
Magnesium levels will be reported as mmol/L
Measured: Baseline
Calcium levels
Calcium levels will be reported as mmol/L
Measured: Baseline
Sodium levels
Sodium levels will be reported as mmol/L
Measured: Baseline
Potassium levels
Potassium levels will be reported as mmol/L
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start13 Dec 2023
- Primary completionDec 2026 (estimated)
- Study completionJun 2038 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart DiseasesStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital
- Responsible party
- Sponsor
- Investigators
- Morten A Høydal, PhD, Study director, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06304233
- Sponsor's protocol ID
- 606103
- Status last verified
- Jul 2026
- First submitted
- 11 Dec 2023
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the study, after deidentification can be shared.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Protein Disrupted in Schizophrenia 1 (DISC1) as a Novel Biomarker for Cardiac Disease - The Link Between DISC1 and Cardiac Function in Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT06304233
- Acronym / sponsor ID
- 606103
- Conditions
- Heart Diseases, Heart; Functional Disturbance, Schizophrenia
- Keywords
- Disrupted in Schizophrenia 1, DISC1, Cardiac Biomarker
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital
- Study start
- 13 Dec 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jun 2038 (estimated)
- First posted
- 12 Mar 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.
To study the association between DISC1 RNA expression levels and cardiac function in patients with schizophrenia.
Detailed description
Potential participants interested in the study will be screened for eligibility. Those who meet the eligibility criteria will be informed about the study, the expected investigations and its potential risks. All participants giving written informed consent will be enrolled into the study. Participants will be interviewed, given questionnaires, have blood and/or skin samples and clinical parameters taken. Cardiac function parameters will be measured using electrocardiography, echocardiography and magnetic resonance imaging.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diagnosed with Schizophrenia | – | Diagnostic Test: Echocardiography, Diagnostic Test: Cardiac Magnetic Resonance Imaging, Diagnostic Test: Electrocardiography, Other: Blood samplingPatients with a ICD-10 diagnosis of Schizophrenia will undergo investigations to assess cardiac function, cardiovascular disease risk factors and DISC1 mRNA expression. Participants eligible for MRI will be invited to undergo cardiac MRI in addition to echocardiography. |
| No mental health diagnosis | – | Diagnostic Test: Echocardiography, Diagnostic Test: Cardiac Magnetic Resonance Imaging, Diagnostic Test: Electrocardiography, Other: Blood samplingParticipants without a mental health diagnosis will be randomly selected from an existing population registered in the HUNT data and biobank for whom, echocardiographic data and biological samples are available.Those enrolled as controls will be invited to participate in the cardiac MRI portion of the study. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The cohort with schizophrenia will be recruited from outpatient and inpatient population from a single centre. The cohort without mental health diagnosis will be selected from an existing population registered in the HUNT data and biobank and be matched for age (± 2 years) and sex of the patients.
Key inclusion criteria (3 listed)
- Patients with ICD-10 schizophrenia, schizotypal or delusional disorders (F20 to F29)
- Both inpatient and outpatient
- Capable of giving informed consent
Key exclusion criteria (4 listed)
- Current or previous diagnosis of cancer
- Current or previous treatment with chemotherapy
- Current pregnancy
- Mothers less than 6 months post-partum
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 |
|---|---|---|
| EchocardiographyAlso: Echoultrasound assessment of heart structure, volume and function | Diagnostic test | Diagnosed with Schizophrenia, No mental health diagnosis |
| Cardiac Magnetic Resonance ImagingAlso: Cardiac MRI, CMRIMRI assessment of heart structure, volume, function and tissue characteristics | Diagnostic test | Diagnosed with Schizophrenia, No mental health diagnosis |
| ElectrocardiographyAlso: Holter, ECGAssessment of cardiac rhythm and electrical activity | Diagnostic test | Diagnosed with Schizophrenia, No mental health diagnosis |
| Blood samplingTo measure DISC1 mRNA expression and other potential biomarkers | Other | Diagnosed with Schizophrenia, No mental health diagnosis |
Primary outcome
Left Ventricular Ejection Fraction (LVEF) measured by 2D Echocardiography
Time frame: Baseline
Left ventricular ejection fraction, LVEF will be reported in percentage (%) and obtained using Simpson's biplane method from 2D echocardiography.
Left Ventricular Ejection Fraction (LVEF) measured by 3D Echocardiography
Time frame: Baseline
Left ventricular ejection fraction, LVEF will be reported in percentage (%) and obtained using 3D echocardiography
DISC1 mRNA quantification
Time frame: Baseline
Measured from blood samples and reported as fold change
Levels of high sensitive-CRP
Time frame: Baseline
Levels of HS-CRP mg/L
Levels of CK-MB
Time frame: Baseline
Levels of CK-MB is reported in µg/L
Levels of Troponin T
Time frame: Baseline
Levels of Troponin T is reported in ng/L
Levels of Troponin I
Time frame: Baseline
Levels of Troponin I is reported in ng/L
Normalized Left Ventricular End-Diastolic Volume (LV EDV), echocardiographic parameter
Time frame: Baseline
LV EDV in milliliters (mL) will be normalized against body surface area (BSA) in m^2 to report LV EDV normalized by BSA in mL/m^2.
Normalized Right Ventricular End-Diastolic Volume (RV EDV), echocardiographic parameter
Time frame: Baseline
RV EDV in mL will be normalized against body surface area (BSA) in m^2 to report RV EDV normalized by BSA in mL/m^2.
Normalized left Ventricular End-Systolic Volume (LV ESV), echocardiographic parameter
Time frame: Baseline
LV ESV in mL will be normalized against body surface area (BSA) in m^2 to report LV ESV normalized by BSA in mL/m^2.
Normalized Right Ventricular End-Systolic Volume (RV ESV), echocardiographic parameter
Time frame: Baseline
RV ESV in mL will be normalized against body surface area (BSA) in m^2 to report RV ESV normalized by BSA in mL/m^2.
Left ventricular mass measured by echocardiography
Time frame: Baseline
Left ventricular mass in grams (g) will be normalized against BSA in m^2 and reported as g/m ^2
Left ventricular septal thickness, left ventricular posterior wall thickness and right ventricular wall thickness measured by echocardiography
Time frame: Baseline
Left ventricular septal thickness, left ventricular posterior wall thickness and right ventricular wall thickness will be reported in centimeters (cm)
Fractional shortening measured by echocardiography
Time frame: Baseline
Fractional shortening will be reported as a percentage (%)
Global longitudinal strain (GLS), echocardiographic parameter
Time frame: Baseline
GLS(%) = (MLs - MLd)/MLd, where MLs is myocardial length at end-systole and MLd is the myocardial length at end-diastole. GLS will be reported in precentage (%)
TAPSE echocardiographic parameter of right ventricular longitudinal systolic function
Time frame: baseline
TAPSE will be reported in millimeters (mm)
Echocardiographic parameter MPI, Myocardial performance index
Time frame: Baseline
MPI is a unitless index derived from the sum of the isovolumic relaxation time (IVRT) and the isovolumic contraction time (IVCT) in milliseconds (ms) divided by the ejection time interval in (ms).
Echocardiographic parameter Mitral E/A ratio
Time frame: Baseline
Mitral E/A ratio is derived from the ratio of the E wave velocity to the A wave velocity
Echocardiography parameter of peak E velocity
Time frame: Baseline
peak E velocity is reported in cm/s
Echocardiography parameter of E wave deceleration time
Time frame: Baseline
E wave deceleration time is reported in milliseconds (ms)
Echocardiography parameter of ratio of E/e'
Time frame: Baseline
The E/e' ratio is derived from the E wave velocity to the e' velocity
Echocardiographic parameters septal e' and lateral e' velocities
Time frame: Baseline
Septal e' and lateral e' velocities are reported as cm/s
Echocardiographic parameter LAVI, left atrial volume indexed
Time frame: Baseline
LAVI is reported in mL/m^2 and is the volume (mL) of the left atrium indexed against the BSA in m^2.
Echocardiographic parameter TRpV, Tricuspid Regurgitation peak Velocity
Time frame: Baseline
TRpV is reported in m/s
Echocardiographic parameter, S wave velocity
Time frame: Baseline
S wave velocity is the peak systolic velocity of the tricuspid annulus and is reported in cm/s
Echocardiographic parameter, Indexed LV and RV stroke volumes
Time frame: Baseline
Indexed LV stroke volume and Indexed RV stroke volume will be reported in mL/m^2 by by indexing the volumes (mL) to BSA (m^2)
Levels of NT-proBNP
Time frame: Baseline
Levels of NT-proBNP from blood samples will be reported in ng/L
Levels of IGF1
Time frame: Baseline
Levels of IGF1 from blood samples will be reported in nmol/L
Levels of ANP
Time frame: Baseline
Levels of ANP from blood samples will be reported in pg/mL
Levels of BDNF, brain derived neurotrophic factor
Time frame: Baseline
Levels of BDNF from blood samples will be reported in ng/mL
Levels of Tumor Necrosis Factor alpha
Time frame: Baseline
Levels of Tumor Necrosis Factor alpha from blood samples will be reported in pg/mL
Levels of Transforming Growth Factor Beta
Time frame: Baseline
Levels of Transforming Growth Factor Beta from blood samples will be reported in ng/mL
Levels of cardiac Myosin-Binding Protein C
Time frame: Baseline
Levels of cardiac Myosin-Binding Protein C from blood samples will be reported in ng/L
Interleukin levels
Time frame: Baseline
Interleukin levels from blood sample will be reported as pg/mL
24 secondary outcomes
native T1 time, cardiac MRI
Time frame: Baseline
Indexed LV and RV end-diastolic, end-systolic and stroke volumes, cardiac MRI
Time frame: Baseline
Indexed LV mass, cardiac MRI
Time frame: Baseline
LV Ejection Fraction, cardiac MRI
Time frame: Baseline
ECG corrected QT interval
Time frame: Baseline
Number of participants with and abnormal ECG
Time frame: Baseline
Number of participants with abnormal liver function
Time frame: Baseline
Number of participants with abnormal kidney function
Time frame: Baseline
Number of participants with abnormal thyroid function
Time frame: Baseline
Number of participants with low Vitamin D levels
Time frame: Baseline
Incidence of cardiovascular disease or mortality as registered in a health registry on follow up
Time frame: Within 15 years from start of study
Triglyceride levels
Time frame: Baseline
High-density lipoprotein, HDL-cholesterol levels
Time frame: Baseline
Low-density lipoprotein, LDL-cholesterol levels
Time frame: Baseline
Fasting glucose levels
Time frame: Baseline
Glycated Hemoglobin (HbA1c) levels
Time frame: Baseline
Heart rate measured on ECG
Time frame: Baseline
Systolic Blood Pressure
Time frame: Baseline
Diastolic Blood Pressure
Time frame: Baseline
Lipoprotein a
Time frame: Baseline
Magnesium levels
Time frame: Baseline
Calcium levels
Time frame: Baseline
Sodium levels
Time frame: Baseline
Potassium levels
Time frame: Baseline
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 8 Jul 2026.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the study, after deidentification can be shared.
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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.
Morten A Høydal, PhD study director
Norwegian University of Science and Technology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Diseases and Heart; Functional Disturbance, run by Norwegian University of Science and Technology at 2 sites in Norway.
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 3 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left Ventricular Ejection Fraction (LVEF) measured by 2D Echocardiography (time frame: Baseline). The study lists 34 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 8 Jul 2026.