DCM - Dilated CardiomyopathyMECHADNCT05284682
Metabolic Characterization of Patients With Dilated Cardiomyopathy
An observational study of DCM - Dilated Cardiomyopathy and Heart Failure, run by Göteborg University at 1 site in Sweden.
Trial summary
The overall aim of the study is to explore the energy metabolism of the failing heart. Primary objective is to understand the differences in the energy metabolism in patients with DCM and heart failure compared to matched controls without heart failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- DCM - Dilated Cardiomyopathy, Heart Failure
- What is being tested?
- Right hearted catheterization
- How many people
- 90 participants
- Where
- 1 siteSweden
- Study dates
- Mar 2022to Jan 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Sahlgrenska University Hospital is a tertiary center for patients in the need of heart failure evaluation. Further, Sahlgrenska University Hospital is included in the assignment as one of the national centers for heart transplantation in Sweden. Patients with advanced HF are referred from the western and northern part of Sweden and as part of clinical evaluation they most often undergo transthoracic echocardiogram (TTE), cardiopulmonary exercise test (CPET) and right-sided heart catheterization (RHC) with myocardial biopsy. The site receives approximately 150 patients for evaluation every year and about 70% have clinically DCM. The study population will be will be recruited from this population. The control population of the study will be recruited from the electrophysiology laboratory.
Who may be able to join
- Signed and dated the Informed Consent Form
- Male and female subjects ≥18 years of age
- Chronic Heart failure (HF) with LVEF ≤40%
- HF due to dilated cardiomyopathy (DCM)
- New York Heart Association (NYHA) class ≥2
- Treatment with basic optimal medical therapy.
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- Clinical indication for invasive evaluation of heart failure
- Signed and dated Informed Consent Form
- Male and female subjects ≥18 years of age
- Clinical indication for electrophysiology examination
Who cannot join
- Life expectancy < 3 years due to other reasons than cardiovascular, cardiac transplantation or left ventricular assist device
- Diabetes mellitus type 1 and 2
- Known hereditary hypercholesterolemia
- Ongoing lipid lowering therapy
- Patients on ketogenic diets
- BMI>35 or <19
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- Pregnancy
- Any current life-threatening cardiac dysrhythmia, cardiac surgery, acute coronary syndrome, or non-elective percutaneous coronary intervention (PCI) <3 months
- Current significant major or unstable respiratory disease
- Considerable hematological disease, hepatic disease, renal disease and/or gastrointestinal disease
- Stroke, transient ischemic attack, carotid surgery or angioplasty <3months
- estimated glomerular filtration rate (eGFR) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI formula) <30 mL/min/1.73m2 or patients on renal dialysis
- Expected inability (by the investigator) to comply with the protocol
- Subjects incapable to giving consent personally
- For control subjects (no heart failure)
- Heart Failure (HFpEF, heart failure with mid-range ejection fraction (HFmrEF) or HFrEF)
- Life expectancy < 3 years due to other reasons than cardiovascular, cardiac transplantation or left ventricular assist device
- Diabetes mellitus type 1 and 2
- Known hereditary hypercholesterolemia
- Ongoing lipid lowering therapy
- Patients on ketogenic diets
- BMI>35 or <19
- Pregnancy
- Any current life-threatening cardiac dysrhythmia, cardiac surgery, acute coronary syndrome, or non-elective PCI <3 months
- Current significant major or unstable respiratory disease
- Considerable hematological disease, hepatic disease, renal disease and/or gastrointestinal disease
- Stroke, transient ischemic attack, carotid surgery or angioplasty <3months,
- eGFR by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI formula) <30 mL/min/1.73m2 or patients on renal dialysis
- Expected inability (by the investigator) to comply with the protocol
- Subjects incapable to giving consent personally
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Sahlgrenska University Hospital
Gothenburg, Western Sweden, 41345
Maria Wideqvist, MD, +46313434416, maria.wideqvist@vgregion.se
About this study
Official title: Metabolic Characterization of Patients With Dilated Cardiomyopathy a Prospective Case-control Study
The overall aim of the study is to explore the energy metabolism of the failing heart.
Primary objective is to understand the differences in the energy metabolism in patients with DCM and heart failure compared to matched controls without heart failure. Secondary objectives, is to understand if optimal medical therapy, including sodium-gucose transporter 2 inhibitors (SGLT2i), alter the cardiac metabolism in DCM-patients. The investigators will also examine if changes in cardiac metabolism happens during exercise in patients with DCM.
This will be done with invasive measurements of a range of energy substrate metabolites in the coronary sinus of the heart in patients with heart failure due to DCM and controls without heart failure respectively. A range of other clinical characteristics will also be examined to characterize patients and controls.
Read the detailed description
Study Design:
The MECHAD study is an explorative prospective cohort study with matched controls including patients with heart failure with reduced ejection fraction (HFrEF, EF≤40%) due to DCM in NYHA-class II-IV, ≥18 years, referred to Department of Cardiology/Sahlgrenska for heart failure work-up. A control group will be collected with age, gender and body mass index (BMI) matched controls without heart failure from the electrophysiology laboratory.
Study Site:
Sahlgrenska University Hospital is a tertiary center for patients in the need of heart failure evaluation, staging and therapy. Further, Sahlgrenska University Hospital is included in the assignment as one of the national centers for heart transplantation in Sweden. Patients with advanced HF are referred from the western and northern parts of Sweden and as part of clinical evaluation they most often undergo transthoracic echocardiogram (TTE), cardiopulmonary exercise test (CPET) as well as right-sided heart catheterization (RHC) with biopsy from the right ventricle septum or the lateral wall in the left ventricle. The site receives approximately 150 patients for evaluation every year and about 70% have clinically DCM.
Patient information and consent:
The Principal Investigator (or delegated sub investigator) will provide each patient with verbal and written information regarding the objectives and procedures of the study and possible risks involved. The patients will be informed about their right to withdraw from the study at any time. Prior to any study related procedures, the informed consent will be reviewed, signed and dated by the patient and investigator. The research unit at the Department of Cardiology/Sahlgrenska University hospital have dedicated research nurses who will facilitate coordination of the study.
Study timetable:
The inclusion in the study is planned to start in Q1 2022 and will continue until 30 patients with HF and 60 patients without HF (controls) are included. The investigators estimate to be able to include one patient per week in average.
Power Calculation and statistical analyses The investigators aim to include 30 patients with HF and 60 matched patients without HF as controls. To calculate the power, data was used from one study in humans showing an increase in 3-hydroxybutanoyl from 0.29 pmol/mg in a non-failing heart to 0.59 pmol/mg in failing heart. This large difference would result in only 2 patients in each group. However, the estimated increase in 3-hydroxybutanoyl does not directly transmitted to our cohort of DCM, therefore a larger sample was chosen.
- Conditions
- DCM - Dilated Cardiomyopathy, Heart Failure
- Being tested
- Right hearted catheterization
- Keywords
- Energy metabolism
- Medical subject headings
- Cardiomyopathy, Dilated, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Right hearted catheterizationDiagnostic test
Right hearted catheterization and collection of blood sampels in the coronary sinus, arterial blood and central venous blood for analysis of energy substrate metabolites.
| Study group | Role | What they receive |
|---|---|---|
| Dilated cardiomyopathy | Patients with heart failure on the basis of dilated cardiomyopathy. Receives: Diagnostic Test: Right hearted catheterization | |
| Control group without heart failure | Control group from the ablation laboratory without heart failure Receives: Diagnostic Test: Right hearted catheterization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic markers
Energy substrate metabolic markers in arterial blood and coronary sinus for the calculation of energy metabolism in the myocardium.
Measured: through study completion, on average 2 years
Secondary outcomes (1)
Metabolic markers after medical optimization
Energy substrate metabolic markers in arterial blood and coronary sinus for the calculation of energy metabolism in the myocardium.
Measured: through study completion, on average 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2022
- Study startMar 2022 (estimated)
- Primary completionJan 2025 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DCM - Dilated CardiomyopathyStudies of the same condition, open and under way.
- More trials run by Göteborg UniversityThe 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Collaborators
- Sahlgrenska University Hospital
- Responsible party
- Sponsor
- Investigators
- Charlotta Ljungman, Principal investigator, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05284682
- Sponsor's protocol ID
- MECHAD
- Acronym
- MECHAD
- Status last verified
- Mar 2022
- First submitted
- 19 Nov 2021
- Last updated
- 17 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Characterization of Patients With Dilated Cardiomyopathy a Prospective Case-control Study
- ClinicalTrials.gov ID
- NCT05284682
- Acronym / sponsor ID
- MECHAD / MECHAD
- Conditions
- DCM - Dilated Cardiomyopathy, Heart Failure
- Keywords
- Energy metabolism
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Collaborators
- Sahlgrenska University Hospital
- Study start
- Mar 2022 (estimated)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 17 Mar 2022 (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.
The overall aim of the study is to explore the energy metabolism of the failing heart.
Primary objective is to understand the differences in the energy metabolism in patients with DCM and heart failure compared to matched controls without heart failure. Secondary objectives, is to understand if optimal medical therapy, including sodium-gucose transporter 2 inhibitors (SGLT2i), alter the cardiac metabolism in DCM-patients. The investigators will also examine if changes in cardiac metabolism happens during exercise in patients with DCM.
This will be done with invasive measurements of a range of energy substrate metabolites in the coronary sinus of the heart in patients with heart failure due to DCM and controls without heart failure respectively. A range of other clinical characteristics will also be examined to characterize patients and controls.
Detailed description
Study Design:
The MECHAD study is an explorative prospective cohort study with matched controls including patients with heart failure with reduced ejection fraction (HFrEF, EF≤40%) due to DCM in NYHA-class II-IV, ≥18 years, referred to Department of Cardiology/Sahlgrenska for heart failure work-up. A control group will be collected with age, gender and body mass index (BMI) matched controls without heart failure from the electrophysiology laboratory.
Study Site:
Sahlgrenska University Hospital is a tertiary center for patients in the need of heart failure evaluation, staging and therapy. Further, Sahlgrenska University Hospital is included in the assignment as one of the national centers for heart transplantation in Sweden. Patients with advanced HF are referred from the western and northern parts of Sweden and as part of clinical evaluation they most often undergo transthoracic echocardiogram (TTE), cardiopulmonary exercise test (CPET) as well as right-sided heart catheterization (RHC) with biopsy from the right ventricle septum or the lateral wall in the left ventricle. The site receives approximately 150 patients for evaluation every year and about 70% have clinically DCM.
Patient information and consent:
The Principal Investigator (or delegated sub investigator) will provide each patient with verbal and written information regarding the objectives and procedures of the study and possible risks involved. The patients will be informed about their right to withdraw from the study at any time. Prior to any study related procedures, the informed consent will be reviewed, signed and dated by the patient and investigator. The research unit at the Department of Cardiology/Sahlgrenska University hospital have dedicated research nurses who will facilitate coordination of the study.
Study timetable:
The inclusion in the study is planned to start in Q1 2022 and will continue until 30 patients with HF and 60 patients without HF (controls) are included. The investigators estimate to be able to include one patient per week in average.
Power Calculation and statistical analyses The investigators aim to include 30 patients with HF and 60 matched patients without HF as controls. To calculate the power, data was used from one study in humans showing an increase in 3-hydroxybutanoyl from 0.29 pmol/mg in a non-failing heart to 0.59 pmol/mg in failing heart. This large difference would result in only 2 patients in each group. However, the estimated increase in 3-hydroxybutanoyl does not directly transmitted to our cohort of DCM, therefore a larger sample was chosen.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dilated cardiomyopathy | – | Diagnostic Test: Right hearted catheterizationPatients with heart failure on the basis of dilated cardiomyopathy. |
| Control group without heart failure | – | Diagnostic Test: Right hearted catheterizationControl group from the ablation laboratory without heart failure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Sahlgrenska University Hospital is a tertiary center for patients in the need of heart failure evaluation. Further, Sahlgrenska University Hospital is included in the assignment as one of the national centers for heart transplantation in Sweden. Patients with advanced HF are referred from the western and northern part of Sweden and as part of clinical evaluation they most often undergo transthoracic echocardiogram (TTE), cardiopulmonary exercise test (CPET) and right-sided heart catheterization (RHC) with myocardial biopsy. The site receives approximately 150 patients for evaluation every year and about 70% have clinically DCM. The study population will be will be recruited from this population. The control population of the study will be recruited from the electrophysiology laboratory.
Key inclusion criteria (10 listed)
- Signed and dated the Informed Consent Form
- Male and female subjects ≥18 years of age
- Chronic Heart failure (HF) with LVEF ≤40%
- HF due to dilated cardiomyopathy (DCM)
- New York Heart Association (NYHA) class ≥2
Key exclusion criteria (30 listed)
- Life expectancy < 3 years due to other reasons than cardiovascular, cardiac transplantation or left ventricular assist device
- Diabetes mellitus type 1 and 2
- Known hereditary hypercholesterolemia
- Ongoing lipid lowering therapy
- Patients on ketogenic diets
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 |
|---|---|---|
| Right hearted catheterizationRight hearted catheterization and collection of blood sampels in the coronary sinus, arterial blood and central venous blood for analysis of energy substrate metabolites. | Diagnostic test | Control group without heart failure, Dilated cardiomyopathy |
Primary outcome
Metabolic markers
Time frame: through study completion, on average 2 years
Energy substrate metabolic markers in arterial blood and coronary sinus for the calculation of energy metabolism in the myocardium.
1 secondary outcome
Metabolic markers after medical optimization
Time frame: through study completion, on average 4 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2022.
- Individual participant dataSharing planned: No
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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.
Charlotta Ljungman principal investigator
Sahlgrenska University Hospital
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 DCM - Dilated Cardiomyopathy and Heart Failure, run by Göteborg University at 1 site in Sweden.
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 10 inclusion and 30 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 17 Mar 2022. 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 Sweden. 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?
Contact Maria Wideqvist (+46313434416, maria.wideqvist@vgregion.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolic markers (time frame: through study completion, on average 2 years). 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 17 Mar 2022.