Understanding how resynchronization therapy works in heart failure
Biological Mechanisms Behind Resynchronization Therapy in Heart Failure
This study looks at how cardiac resynchronization therapy works in people with heart failure by collecting samples and data to see how their hearts respond before and after treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 220 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Region Stockholm Government |
| Locations | 1 site (Stockholm) |
| Trial ID | NCT06140914 on ClinicalTrials.gov |
What this trial studies
This study investigates the biological mechanisms behind cardiac resynchronization therapy (CRT) in patients with heart failure and reduced ejection fraction. It involves collecting blood samples, heart tissue, and clinical data from eligible heart failure patients, both those set to receive CRT and those on medical therapy. Patients will be assessed at multiple time points, including before CRT implantation and at 3, 6, and 12 months post-treatment. The analysis will focus on proteins, exosomal miRNA, and heart tissue contractility to better understand patient responses to CRT.
Who should consider this trial
Good fit: Ideal candidates include heart failure patients with an ejection fraction of 35% or less and left bundle branch block who are eligible for CRT.
Not a fit: Patients who are pregnant or unable to provide informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify which heart failure patients are likely to benefit from CRT, potentially improving treatment outcomes.
How similar studies have performed: While studies on CRT exist, this specific approach focusing on biological mechanisms and patient stratification is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 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. 2. Ability to understand the given information. 3. Ability to give informed consent. Exclusion Criteria: 1. Pregnant or planning pregnancy 2. Not able to give informed consent -
Where this trial is running
Stockholm
- Karolinska Universitetssjukhuset — Stockholm, Sweden (Recruiting)
Study contacts
- Principal investigator: Marcus Ståhlberg, PhD — Karolinska Universitetssjukhuset
- Study coordinator: Karin Ljung, PhD
- Email: karin.a.ljung@regionstockholm.se
- Phone: 0046739128078
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.