Clinical trial NCT06435585: Responders and Non-responders in the Management of Heart Failure - Significance of Genetic Influence and Identification of Novel Informative Biomarkers
Official title: Responders and Non-responders in the Management of Heart Failure - Significance of Genetic Influence and Identification of Novel Informative Biomarkers
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Heart Failure
Pathophysiology
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
Collaborators: name: University Hospital, Linkoeping
First posted: 2024-05-30
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: PAtients with heart failure in Sweden with a registration in SwedeHF.

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

1. Written informed consent
2. Heart failure defined by symptoms and signs of heart failure as judged by the local investigator
3. Registered in SwedeHF

Exclusion Criteria:

1. Plasma donation within 1 month of enrolment or any blood donation/blood loss \>500 mL during the 3 months prior to enrolment
2. Previous allogeneic bone marrow transplant (genetics)
3. 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.

Primary outcomes:
measure: Identify responders to guideline-directed medical therapy
timeFrame: 2 and 5 years
measure: Differences in morbidity between responders and non-responders to guideline-directed medical therapy
timeFrame: 2 years
measure: Differences in mortality between responders and non-responders to guideline-directed medical therapy
timeFrame: 2 years
measure: Predictors of responders and non-responders to guideline-directed medical therapy
timeFrame: 2 and 5 years
Secondary outcomes:
measure: Differences between responders and non-responders regarding mortality
timeFrame: 2 and 5 years
measure: Differences between responders and non-responders regarding morbidity
timeFrame: 2 and 5 years
measure: Predictors of mortality in responders and non-responders
timeFrame: 2 and 5 years
measure: Predictors of morbidity in responders and non-responders
timeFrame: 2 and 5 years
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University hospital
Study officials:
References: