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

Heart Failure Clinical Trial

— Responders  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06435585
• Other study ID #: 218/443-31
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Heart Failure
• Pathophysiology

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