RecruitingNot Applicable

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

Sweden5,000 participantsStarted 2021-02-17

Plain-language summary

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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

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

Exclusion criteria

. 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Identify responders to guideline-directed medical therapy

Timeframe: 2 and 5 years

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

Timeframe: 2 years

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

Timeframe: 2 years

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

Timeframe: 2 and 5 years

Trial details

NCT IDNCT06435585

SponsorKarolinska University Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2030-12-31

Contact for this trial

Camilla Hage, Ass prof

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

View on ClinicalTrials.gov More Heart Failure trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

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

Exclusion criteria

. 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.

What they're measuring

Identify responders to guideline-directed medical therapy

Timeframe: 2 and 5 years

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

Timeframe: 2 years

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

Timeframe: 2 years

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

Timeframe: 2 and 5 years