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

Plain Language Summary

Simplified for easier understanding

This study is investigating the biological changes that happen in the heart and blood when heart failure patients receive cardiac resynchronization therapy (CRT) — a pacemaker-like device that helps the heart's two lower chambers beat in sync. Researchers want to understand why CRT works for some patients but not others. **You may be eligible if...** - You have heart failure with a weakened heart (ejection fraction 35% or less) - You either have a specific type of electrical conduction problem in your heart (left bundle branch block with QRS ≥150 ms) or depend heavily on a pacemaker, AND are scheduled for CRT at Karolinska University Hospital - OR you are being followed medically at Karolinska University Hospital for heart failure without a CRT device - You are able to understand the study information and give informed consent **You may NOT be eligible if...** - You are pregnant or planning to become pregnant - You are unable to give informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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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