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Biological Mechanisms Behind Resynchronization Therapy in Heart Failure

NCT06140914 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 220

Last updated 2023-11-21

No results posted yet for this study

Summary

Heart failure is a common disease, affecting 2-3% of the population in the western world. About 30% of patients with heart failure and reduced ejection fraction display signs of electrical dyssynchrony on ECG, usually left bundle branch block (LBBB), which is associated with a worse prognosis. Cardiac resynchronization therapy (CRT) reduce mortality for patients with dyssynchronic heart failure, defined as ejection fraction (EF) = or \< 35% and LBBB. About 1/3 of the patients that fit CRT criteria will not respond to CRT. Which patients that will turn out to be non-responders cannot be anticipated beforehand.

We have started a clinical study to collect blood samples, heart tissue and clinical data from heart failure patients eligible for CRT and a control group of heart failure patients on medical therapy. Patients will be assessed before CRT implantation or early after initiation of medical treatment, at 3 months, 6 months and 12 months.

Blood samples and tissue will be analysed in the search for (i) biomarkers to separate CRT responders from non-responders and (ii) mechanisms behind the remodelling observed in CRT and with medical therapy.

Conditions

Interventions

DIAGNOSTIC_TEST

Proteomics, miRNA studies and studies of blood cells from blood samples

This is an observational study where we follow patients and save blood samples and biopsies for analysis as described above.

Sponsors & Collaborators

  • Region Stockholm

    lead OTHER_GOV

Principal Investigators

  • Marcus Ståhlberg, PhD · Karolinska Universitetssjukhuset

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-15
Primary Completion
2026-03-31
Completion
2026-03-31

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06140914 on ClinicalTrials.gov