RecruitingNCT06140914

Biological Mechanisms Behind Resynchronization Therapy in Heart Failure


Sponsor

Region Stockholm

Enrollment

220 participants

Start Date

Mar 15, 2023

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria5

  • Ejection fraction (EF) = or \< 35% and A or B
  • A) Left bundle branch block (LBBB) QRS = or \> 150 ms or a high proportion ventricular pacing and planned for CRT at Karolinska University Hospital.
  • B) Planned for medical treatment and followed at Karolinska University Hospital.
  • Ability to understand the given information.
  • Ability to give informed consent.

Exclusion Criteria2

  • Pregnant or planning pregnancy
  • Not able to give informed consent -

Interventions

DIAGNOSTIC_TESTProteomics, 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.


Locations(1)

Karolinska Universitetssjukhuset

Stockholm, Sweden

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NCT06140914


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