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Responders and Non-responders in the Management of Heart Failure - Significance of Genetic Influence and Identification of Novel Informative Biomarkers

Responders and Non-responders in the Management of Heart Failure - Significance of Genetic Influence and Identification of Novel Informative Biomarkers

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06435585
Acronym
Responders
Enrollment
5000
Registered
2024-05-30
Start date
2021-02-17
Completion date
2030-12-31
Last updated
2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure, Pathophysiology

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.

Interventions

None listed

Sponsors

Karolinska University Hospital
Lead SponsorOTHER
University Hospital, Linkoeping
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Identify responders to guideline-directed medical therapy2 and 5 yearsTo identify which patient will be a non-responder resulting in a poor outcome, despite being on recommended treatment according to guidelines.
Differences in morbidity between responders and non-responders to guideline-directed medical therapy2 yearsTo characterize differences between responders and non-responders in terms of morbidity after 2-years follow-up.
Differences in mortality between responders and non-responders to guideline-directed medical therapy2 yearsTo characterize differences between responders and non-responders in terms of mortality after 2-years follow-up.
Predictors of responders and non-responders to guideline-directed medical therapy2 and 5 yearsTo integrate information regarding clinical characteristics, diagnostic markers and genetics to determine underlying mechanisms behind different responses to treatment.

Secondary

MeasureTime frameDescription
Differences between responders and non-responders regarding mortality2 and 5 yearsTo evaluate the differences between HFrEF and HFpEF patients in terms of mortality and after 2 and 5 years follow-up, respectively.
Differences between responders and non-responders regarding morbidity2 and 5 yearso evaluate the differences between HFrEF and HFpEF patients in terms of morbidity after 2 and 5 years follow-up, respectively.
Predictors of mortality in responders and non-responders2 and 5 yearsTo evaluate the differences in mortality between patients with HFrEF and HFpEF by integrating information from clinical characteristics, diagnostic markers and genetics in order to have a further understanding of the underlying pathophysiology involved in HF development and prognosis with the aim to facilitate improved individualized therapy with less adverse effects and to identify novel treatment targets.
Predictors of morbidity in responders and non-responders2 and 5 yearsTo evaluate the differences in morbidity between patients with HFrEF and HFpEF by integrating information from clinical characteristics, diagnostic markers and genetics in order to have a further understanding of the underlying pathophysiology involved in HF development and prognosis with the aim to facilitate improved individualized therapy with less adverse effects and to identify novel treatment targets.

Countries

Sweden

Contacts

CONTACTCamilla Hage, Ass prof
camilla.hage@regionstockholm.se+46 (0)703340660
CONTACTUlf Dahlström, Prof
ulf.dahlstrom@liu.se

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 11, 2026