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

NCT06435585 | Recruiting

• 1 other identifier: 218/443-31
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Heart Failure; Pathophysiology

Outcome Measures

Primary Outcomes (4)

• Identify responders to guideline-directed medical therapy

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

  2 and 5 years

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

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

  2 years

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

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

  2 years

• Predictors of responders and non-responders to guideline-directed medical therapy

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

  2 and 5 years

Secondary Outcomes (4)

• Differences between responders and non-responders regarding mortality

  2 and 5 years

• Differences between responders and non-responders regarding morbidity

  2 and 5 years

• Predictors of mortality in responders and non-responders

  2 and 5 years

• Predictors of morbidity in responders and non-responders

  2 and 5 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

PAtients with heart failure in Sweden with a registration in SwedeHF.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Karolinska University Hospital: lead
• University Hospital, Linkoeping: collaborator

Study Sites (1)

Karolinska University hospital

Stockholm, 17164, Sweden

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Plasma, serum, whole blood, urine

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Camilla Hage, Ass prof

CONTACT

+46 (0)703340660; camilla.hage@regionstockholm.se

Ulf Dahlström, Prof

CONTACT

ulf.dahlstrom@liu.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 20, 2024
• First Posted: May 30, 2024
• Study Start: February 17, 2021
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: May 30, 2024

Record last verified: 2024-05

Locations

SE (1)