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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06435585
Other study ID # 218/443-31
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 17, 2021
Est. completion date December 31, 2030

Study information

Verified date May 2024
Source Karolinska University Hospital
Contact Camilla Hage, Ass prof
Phone +46 (0)703340660
Email camilla.hage@regionstockholm.se
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Sweden Karolinska University hospital Stockholm

Sponsors (2)

Lead Sponsor Collaborator
Karolinska University Hospital University Hospital, Linkoeping

Country where clinical trial is conducted

Sweden, 

Outcome

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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