Responders and Non-responders in the Management of Heart Failure - Significance of Genetic Influence and Identification of Novel Informative Biomarkers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Heart Failure, Pathophysiology. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
A biobank within the Swedish national heart failure quality registry SwedeHF.
Detailed description
The national heart failure quality registry SwedeHF started in 2003. It is the world's largest continuous HF registry enrolling clinician-judged HF (regardless of LVEF) at time of hospital or clinical visit. Eighty variables are entered into an electronic database managed by the Uppsala Clinical Research Center (UCR). There are \>140,000 registrations from \>110,000 unique patients from 70 hospitals in Sweden.
University hospitals in Sweden with access to central biobanking will collect a high-quality biobank linked to SwedeHF consisting of blood plasma, whole blood and urine enabling genetic, proteomic and metabolomic analyses as well as analyses of different biomarkers of interest for HF patients. This will provide unique opportunities for future research within the national SwedeHF registry.
Primary outcome measures
- Identify responders to guideline-directed medical therapy [Time frame: 2 and 5 years]
- Differences in morbidity between responders and non-responders to guideline-directed medical therapy [Time frame: 2 years]
- Differences in mortality between responders and non-responders to guideline-directed medical therapy [Time frame: 2 years]
- Predictors of responders and non-responders to guideline-directed medical therapy [Time frame: 2 and 5 years]
Secondary outcome measures (4)
- Differences between responders and non-responders regarding mortality [Time frame: 2 and 5 years]
- Differences between responders and non-responders regarding morbidity [Time frame: 2 and 5 years]
- Predictors of mortality in responders and non-responders [Time frame: 2 and 5 years]
- Predictors of morbidity in responders and non-responders [Time frame: 2 and 5 years]
Eligibility criteria
Inclusion criteria
- Written informed consent
- Heart failure defined by symptoms and signs of heart failure as judged by the local investigator
- Registered in SwedeHF
Exclusion criteria
- Plasma donation within 1 month of enrolment or any blood donation/blood loss >500 mL during the 3 months prior to enrolment
- Previous allogeneic bone marrow transplant (genetics)
- In the opinion of the investigator, condition/s that may either put the patient at risk on participation or influence the results or the patient's ability to participate in the study.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Sweden · 1 center
- Karolinska University hospital — Stockholm
Publications
- Hage C, Andersson T, Christersson C, Linde C, Lund LH, Karlstrom P, Chatziapostolou D, Dagner V, Granstrom F, Gylling A, Jonsson A, Haglund P, Hogberg J, Odenstedt A, Viklund U, Magnusson M, Smith JG, Szabo-Soderberg B, Ostgard Thunstrom E, Dahlstrom U. An integrated Biobank in the Swedish Heart Failure Registry-clinomics, proteomics, transcriptomics and genomics. ESC Heart Fail. 2026 Mar 3;13(2): PMID 41961636
Identifiers
NCT: NCT06435585 · 218/443-31