Observational Study on Cardiac Biomarkers Testing in Patients with Muscular Dystrophy Cardiomyopathy

NCT05779202 | Completed

• 1 other identifier: KYMA
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Cardiomyopathies; Skeletal Muscle Disorder

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  6 months

Secondary Outcomes (1)

• Longitudinal follow-up of novel laboratory biomarkers for prognostic significance.

  unlimited

Interventions

No intervention is planned. OTHER

No intervention is planned.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• Written informed consent
• Diagnosed muscular dystrophy
• Patients \>18 years of age

You may not qualify if:

• Patients with poor venous status
• Hemodialysis
• Lack of capacity to provide informed consent or refusal

Sponsors & Collaborators

• University Hospital Heidelberg: lead

Study Sites (1)

University Hospital of Heidelberg

Heidelberg, Baden-Wurttemberg, 69120, Germany

Location

Biospecimen

Retention: SAMPLES WITH DNA

Routine blood samples at presentation, a second blood sample for study purposes will be collected after 1 hour of the first index visit. On the routine follow-up visit, we will collect 20 ml for storage in addition to the routine blood test. Blood samples will be obtained by standard venous blood sampling. Assessment of parameters include 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.

MeSH Terms

Conditions

Cardiomyopathies; Muscular Diseases

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 7, 2023
• First Posted: March 22, 2023
• Study Start: April 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)