CardiomyopathiesKYMANCT05779202
Observational Study on Cardiac Biomarkers Testing in Patients with Muscular Dystrophy Cardiomyopathy
An observational study of Cardiomyopathies and Skeletal Muscle Disorder, run by University Hospital Heidelberg at 1 site in Germany.
Trial summary
The objective of this study is to evaluate acute changes of cardiac troponin (and other cardiac biomarkers) and mid-term biovariability in patients with cardiomyopathy associated with chronic skeletal muscle disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiomyopathies, Skeletal Muscle Disorder
- How many people
- 35 participants
- Where
- 1 siteGermany
- Study dates
- 1 Apr 2023to 31 Dec 2024
- How long will I take part?
- 6 Months
- 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: All consecutive patients with cardiomyopathy associated with chronic skeletal muscle disease presenting at Heidelberg University Hospital in the cardiomyopathy outpatients' clinic during a time period of 12 months are eligible for study inclusion.
Who may be able to join
- Written informed consent
- Diagnosed muscular dystrophy
- Patients >18 years of age
Who cannot join
- Patients with poor venous status
- Hemodialysis
- Lack of capacity to provide informed consent or refusal
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital of Heidelberg
Heidelberg, Baden-Wurttemberg, 69120
About this study
Official title: Observational Study on Cardiac Biomarkers Testing in Patients with Muscular Dystrophy Cardiomyopathy and Assessing the Feasibility of Serial Cardiac Troponin Testing At 0 Hour and 1 Hour, As Well As the Mid-term Biovariability of Cardiac Troponin
The objective of this study is to evaluate acute changes of cardiac troponin (and other cardiac biomarkers) and mid-term biovariability in patients with cardiomyopathy associated with chronic skeletal muscle disease. The specific aims of the study are:
Firstly, to evaluate the feasibility of the ESC 0/1 hour protocol for rule-in and rule-out of a non-ST-segment elevation acute coronary syndrome (NSTE-ACS).
Secondly, a) to determine reference change values (RCV) to characterize physiological biovariability, b) to differentiate acute from chronic high-sensitivity cardiac troponin T (hs-cTnT) elevations.
Read the detailed description
In patients with skeletal muscle dystrophy, cardiac involvement is one of the limiting factors regarding mortality. Early detection of a dystrophy-associated cardiomyopathy is important, as heart failure therapy can slow adverse cardiac remodeling and alleviate heart failure symptoms. Cardiac biomarkers, especially high-sensitivity cardiac Troponin T (hs-cTnT) and to a lesser extent, high-sensitivity cardiac Troponin I (hs-cTnI), are chronically elevated in diseases with underlying structural heart disease. However, there is no reliable data on whether changes in the concentration of cardiac Troponin T or I are suitable for monitoring the cardiac disease progression. This can lead to delayed diagnosis and treatment of a relevant deterioration of the disease or even acute heart muscle damage in the context of acute myocardial infarction, pulmonary embolism, and myocarditis. Due to insufficient clinical data, the feasibility and safety of the ESC 0/1-hour protocol according to the ESC guidelines for the diagnosis of acute myocardial infarction in this patient population are uncertain. Furthermore, it is necessary to determine the normal biovariability of high-sensitivity cardiac Troponin T (hs-cTnT) and high-sensitivity cardiac Troponin I (hs-cTnI) to differentiate physiological concentration fluctuations of these cardiac biomarkers in this patient population from changes that represent an improvement or deterioration of heart function. Routine blood samples that will be collected at presentation, a second blood sample for study purposes will be collected after 1 hour for the first index visit. On the routine follow-up visit, 20 ml of blood will be collected for storage in addition to the routine blood test. Blood samples will be obtained by standard venous blood sampling. If venipuncture is unsuccessful or considered harmful by the patient and a suitable peripheral venous catheter is available, the venous catheter may be used for blood sampling to minimize damage. Assessment of parameters includes demographics and clinical characteristics (symptoms, history, medication, vital signs, risk scores etc.) and laboratory values with special focus on findings related to myocardial injury as indicated by high sensitivity cardiac troponin T (hs-cTnT) and hs-cTnI. Moreover, the laboratory panel comprises other cardiac biomarkers, electrolytes, renal (creatine, glomerular filtration rate) and liver function (GOT, GPT, LDH), C-reactive protein, D-dimer etc.
- Conditions
- Cardiomyopathies, Skeletal Muscle Disorder
- Being tested
- No intervention is planned.
- Medical subject headings
- Cardiomyopathies, Muscular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention is planned.Other
No intervention is planned.
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of stable troponin kinetics in patients
The first main objective is to determine the prevalence of stable troponin kinetics defined as high-sensitivity Troponin T (hour 0) : high-sensitivity Troponin T (hour 1) < 5 ng/l at baseline presentation.
Measured: 1 hour
Reference Change Values calculation for cardiac biomarkers
The second main objective is to calculate the Reference Change Values (RCV) of high-sensitivity Troponin T within the 6-month follow-up period.
Measured: 6 months
Secondary outcomes (1)
Longitudinal follow-up of novel laboratory biomarkers for prognostic significance.
Thirdly, longitudinal follow-up of the patients will be conducted once a year to clarify the prognostic significance of novel laboratory biomarkers.
Measured: unlimited
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2023
- Study start1 Apr 2023
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CardiomyopathiesStudies of the same condition, open and under way.
- More trials run by University Hospital HeidelbergThe 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
- 35 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- University Hospital Heidelberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa Yildirim, University Hospital Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05779202
- Sponsor's protocol ID
- KYMA
- Acronym
- KYMA
- Status last verified
- Mar 2025
- First submitted
- 7 Mar 2023
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study on Cardiac Biomarkers Testing in Patients with Muscular Dystrophy Cardiomyopathy and Assessing the Feasibility of Serial Cardiac Troponin Testing At 0 Hour and 1 Hour, As Well As the Mid-term Biovariability of Cardiac Troponin
- ClinicalTrials.gov ID
- NCT05779202
- Acronym / sponsor ID
- KYMA / KYMA
- Conditions
- Cardiomyopathies, Skeletal Muscle Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University Hospital HeidelbergUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 22 Mar 2023 (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 objective of this study is to evaluate acute changes of cardiac troponin (and other cardiac biomarkers) and mid-term biovariability in patients with cardiomyopathy associated with chronic skeletal muscle disease. The specific aims of the study are:
Firstly, to evaluate the feasibility of the ESC 0/1 hour protocol for rule-in and rule-out of a non-ST-segment elevation acute coronary syndrome (NSTE-ACS).
Secondly, a) to determine reference change values (RCV) to characterize physiological biovariability, b) to differentiate acute from chronic high-sensitivity cardiac troponin T (hs-cTnT) elevations.
Detailed description
In patients with skeletal muscle dystrophy, cardiac involvement is one of the limiting factors regarding mortality. Early detection of a dystrophy-associated cardiomyopathy is important, as heart failure therapy can slow adverse cardiac remodeling and alleviate heart failure symptoms. Cardiac biomarkers, especially high-sensitivity cardiac Troponin T (hs-cTnT) and to a lesser extent, high-sensitivity cardiac Troponin I (hs-cTnI), are chronically elevated in diseases with underlying structural heart disease. However, there is no reliable data on whether changes in the concentration of cardiac Troponin T or I are suitable for monitoring the cardiac disease progression. This can lead to delayed diagnosis and treatment of a relevant deterioration of the disease or even acute heart muscle damage in the context of acute myocardial infarction, pulmonary embolism, and myocarditis. Due to insufficient clinical data, the feasibility and safety of the ESC 0/1-hour protocol according to the ESC guidelines for the diagnosis of acute myocardial infarction in this patient population are uncertain. Furthermore, it is necessary to determine the normal biovariability of high-sensitivity cardiac Troponin T (hs-cTnT) and high-sensitivity cardiac Troponin I (hs-cTnI) to differentiate physiological concentration fluctuations of these cardiac biomarkers in this patient population from changes that represent an improvement or deterioration of heart function. Routine blood samples that will be collected at presentation, a second blood sample for study purposes will be collected after 1 hour for the first index visit. On the routine follow-up visit, 20 ml of blood will be collected for storage in addition to the routine blood test. Blood samples will be obtained by standard venous blood sampling. If venipuncture is unsuccessful or considered harmful by the patient and a suitable peripheral venous catheter is available, the venous catheter may be used for blood sampling to minimize damage. Assessment of parameters includes demographics and clinical characteristics (symptoms, history, medication, vital signs, risk scores etc.) and laboratory values with special focus on findings related to myocardial injury as indicated by high sensitivity cardiac troponin T (hs-cTnT) and hs-cTnI. Moreover, the laboratory panel comprises other cardiac biomarkers, electrolytes, renal (creatine, glomerular filtration rate) and liver function (GOT, GPT, LDH), C-reactive protein, D-dimer etc.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All consecutive patients with cardiomyopathy associated with chronic skeletal muscle disease presenting at Heidelberg University Hospital in the cardiomyopathy outpatients' clinic during a time period of 12 months are eligible for study inclusion.
Key inclusion criteria (3 listed)
- Written informed consent
- Diagnosed muscular dystrophy
- Patients >18 years of age
Key exclusion criteria (3 listed)
- Patients with poor venous status
- Hemodialysis
- Lack of capacity to provide informed consent or refusal
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 |
|---|---|---|
| No intervention is planned.No intervention is planned. | Other | – |
Primary outcome
Prevalence of stable troponin kinetics in patients
Time frame: 1 hour
The first main objective is to determine the prevalence of stable troponin kinetics defined as high-sensitivity Troponin T (hour 0) : high-sensitivity Troponin T (hour 1) < 5 ng/l at baseline presentation.
Reference Change Values calculation for cardiac biomarkers
Time frame: 6 months
The second main objective is to calculate the Reference Change Values (RCV) of high-sensitivity Troponin T within the 6-month follow-up period.
1 secondary outcome
Longitudinal follow-up of novel laboratory biomarkers for prognostic significance.
Time frame: unlimited
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Cardiomyopathies and Skeletal Muscle Disorder, run by University Hospital Heidelberg 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 30 Mar 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Prevalence of stable troponin kinetics in patients (time frame: 1 hour). 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 30 Mar 2025.