Heart Failure Clinical Trial
— RespondersOfficial title:
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.
Status | Recruiting |
Enrollment | 5000 |
Est. completion date | December 31, 2030 |
Est. primary completion date | December 31, 2030 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Sweden | Karolinska University hospital | Stockholm |
Lead Sponsor | Collaborator |
---|---|
Karolinska University Hospital | University Hospital, Linkoeping |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | 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. | 2 and 5 years | |
Secondary | 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. | 2 and 5 years | |
Secondary | 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. | 2 and 5 years | |
Secondary | 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. | 2 and 5 years |
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