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NCT Number: NCT06435585

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

A biobank within the Swedish national heart failure quality registry SwedeHF.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases Pathophysiology

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Karolinska University hospital

Stockholm, 17164, Sweden

Location status: Recruiting

Location contact

Barna Szabo, MD

PRINCIPAL_INVESTIGATOR

Camilla Hage, Ass prof

CONTACT

[email protected]

+46 (0)703340660

Carin Cabrera, MD, PhD

PRINCIPAL_INVESTIGATOR

Christina Christersson, MD, Ass prof

PRINCIPAL_INVESTIGATOR

Erik Ostgärd Thunstrom, MD, Ass prof

PRINCIPAL_INVESTIGATOR

Martin Magnusson, MD, Prof

PRINCIPAL_INVESTIGATOR

Patric Karlstrom, MD, PhD

PRINCIPAL_INVESTIGATOR

Therese Andersson, MD, PhD

PRINCIPAL_INVESTIGATOR

Ulf Dahlström, MD, Prof

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Identify responders to guideline-directed medical therapy

    Time frame: 2 and 5 years

    To identify which patient will be a non-responder resulting in a poor outcome, despite being on recommended treatment according to guidelines.

  2. Differences in morbidity between responders and non-responders to guideline-directed medical therapy

    Time frame: 2 years

    To characterize differences between responders and non-responders in terms of morbidity after 2-years follow-up.

  3. Differences in mortality between responders and non-responders to guideline-directed medical therapy

    Time frame: 2 years

    To characterize differences between responders and non-responders in terms of mortality after 2-years follow-up.

  4. Predictors of responders and non-responders to guideline-directed medical therapy

    Time frame: 2 and 5 years

    To integrate information regarding clinical characteristics, diagnostic markers and genetics to determine underlying mechanisms behind different responses to treatment.

Secondary outcomes

  1. Differences between responders and non-responders regarding mortality

    Time frame: 2 and 5 years

    To evaluate the differences between HFrEF and HFpEF patients in terms of mortality and after 2 and 5 years follow-up, respectively.

  2. Differences between responders and non-responders regarding morbidity

    Time frame: 2 and 5 years

    o evaluate the differences between HFrEF and HFpEF patients in terms of morbidity after 2 and 5 years follow-up, respectively.

  3. Predictors of mortality in responders and non-responders

    Time frame: 2 and 5 years

    To 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.

  4. Predictors of morbidity in responders and non-responders

    Time frame: 2 and 5 years

    To 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Camilla Hage, Ass prof

CONTACT

[email protected]

+46 (0)703340660

Ulf Dahlström, Prof

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Karolinska University Hospital

Other

Collaborators

  • University Hospital, Linkoeping

Registry information

Acronym: Responders

Important dates

Study start
2021
Primary completion
2030
Study completion
2030
First posted
May 30, 2024
Registry last updated
May 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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