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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorKarolinska University Hospital

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Written informed consent

Heart failure defined by symptoms and signs of heart failure as judged by the local investigator

Registered in SwedeHF

Disqualifiers

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.

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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.

Time frame
2 and 5 years
2

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.

Time frame
2 years
3

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.

Time frame
2 years
4

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.

Time frame
2 and 5 years

Secondary outcomes

1

Differences between responders and non-responders regarding mortality

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

Time frame
2 and 5 years
2

Differences between responders and non-responders regarding morbidity

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

Time frame
2 and 5 years
3

Predictors of mortality in responders and non-responders

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.

Time frame
2 and 5 years
4

Predictors of morbidity in responders and non-responders

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.

Time frame
2 and 5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Karolinska University Hospital

Lead sponsor

University Hospital, Linkoeping

Collaborator