Biological Mechanisms Behind Resynchronization Therapy in Heart Failure

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
View:

• 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.

Locations
Other Locations
Sweden
Karolinska Universitetssjukhuset
RECRUITING
Stockholm
Contact Information
Primary
Karin Ljung, PhD
karin.a.ljung@regionstockholm.se
0046739128078
Time Frame
Start Date: 2023-03-15
Estimated Completion Date: 2026-03
Participants
Target number of participants: 220
Treatments
CRT
Heart failure patients that receive a CRT
Control
Heart failure patients treated with medicines, without a CRT indication.
Related Therapeutic Areas
Sponsors
Leads: Region Stockholm

This content was sourced from clinicaltrials.gov

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