Heart Failure Clinical Trial
Official title:
Biological Mechanisms Behind Resynchronization Therapy in Heart Failure
NCT number | NCT06140914 |
Other study ID # | CRT K 2022-8295 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | March 15, 2023 |
Est. completion date | March 2026 |
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.
Status | Recruiting |
Enrollment | 220 |
Est. completion date | March 2026 |
Est. primary completion date | March 2026 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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 - |
Country | Name | City | State |
---|---|---|---|
Sweden | Karolinska Universitetssjukhuset | Stockholm |
Lead Sponsor | Collaborator |
---|---|
Region Stockholm |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Mechanism behind the reverse remodelling in CRT responders and with medical treatment | Proteomics, RNA studies, force-calcium studies | 2023-2028 | |
Primary | Biomarkers | Proteins or exosomal miRNA from blood to separate CRT responders from non-responders | 2023-2028 | |
Secondary | Endothelial function | EndoPAT and RBC studies to separate CRT responders from non-responders | 2023-2028 |
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