Metabolic Characterization of Patients With Dilated Cardiomyopathy

NCT05284682 | Unknown DMC

• 1 other identifier: MECHAD
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

DCM - Dilated Cardiomyopathy; Heart Failure

Keywords

Energy metabolism

Outcome Measures

Primary Outcomes (1)

• Metabolic markers

  Energy substrate metabolic markers in arterial blood and coronary sinus for the calculation of energy metabolism in the myocardium.

  through study completion, on average 2 years

Secondary Outcomes (1)

• Metabolic markers after medical optimization

  through study completion, on average 4 years

Study Arms (2)

Dilated cardiomyopathy

Patients with heart failure on the basis of dilated cardiomyopathy.

Diagnostic Test: Right hearted catheterization

Control group without heart failure

Control group from the ablation laboratory without heart failure

Diagnostic Test: Right hearted catheterization

Interventions

Right hearted catheterization DIAGNOSTIC_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.

Control group without heart failure; Dilated cardiomyopathy

Eligibility Criteria

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

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.

You may qualify if:

• 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.
• Clinical indication for invasive evaluation of heart failure

You may not qualify if:

• 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 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)

Sponsors & Collaborators

• Göteborg University: lead
• Sahlgrenska University Hospital: collaborator

Study Sites (1)

Sahlgrenska University Hospital

Gothenburg, Western Sweden, 41345, Sweden

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood

MeSH Terms

Conditions

Cardiomyopathy, Dilated; Heart Failure

Condition Hierarchy (Ancestors)

Cardiomegaly; Heart Diseases; Cardiovascular Diseases; Cardiomyopathies; Laminopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Charlotta Ljungman

  Sahlgrenska University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Wideqvist

CONTACT

+46313434416; maria.wideqvist@vgregion.se

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2021
• First Posted: March 17, 2022
• Study Start: March 1, 2022
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2026
• Last Updated: March 17, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)