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

May 24, 2024 updated by: Camilla Hage, Karolinska University Hospital
A biobank within the Swedish national heart failure quality registry SwedeHF.

Study Overview

Status

Recruiting

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Estimated)

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Sweden
      • Stockholm, Sweden, 17164
        • Recruiting
        • Karolinska University Hospital
        • Contact:
        • Principal Investigator:
          • Ulf Dahlström, MD, Prof
        • Principal Investigator:
          • Erik Ostgärd Thunstrom, MD, Ass prof
        • Principal Investigator:
          • Christina Christersson, MD, Ass prof
        • Principal Investigator:
          • Martin Magnusson, MD, Prof
        • Principal Investigator:
          • Barna Szabo, MD
        • Principal Investigator:
          • Therese Andersson, MD, PhD
        • Principal Investigator:
          • Carin Cabrera, MD, PhD
        • Principal Investigator:
          • Patric Karlstrom, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identify responders to guideline-directed medical therapy
Time Frame: 2 and 5 years
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
Differences in morbidity between responders and non-responders to guideline-directed medical therapy
Time Frame: 2 years
To characterize differences between responders and non-responders in terms of morbidity after 2-years follow-up.
2 years
Differences in mortality between responders and non-responders to guideline-directed medical therapy
Time Frame: 2 years
To characterize differences between responders and non-responders in terms of mortality after 2-years follow-up.
2 years
Predictors of responders and non-responders to guideline-directed medical therapy
Time Frame: 2 and 5 years
To integrate information regarding clinical characteristics, diagnostic markers and genetics to determine underlying mechanisms behind different responses to treatment.
2 and 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differences between responders and non-responders regarding mortality
Time Frame: 2 and 5 years
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
Differences between responders and non-responders regarding morbidity
Time Frame: 2 and 5 years
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
Predictors of mortality in responders and non-responders
Time Frame: 2 and 5 years
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
Predictors of morbidity in responders and non-responders
Time Frame: 2 and 5 years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska University Hospital

Collaborators

University Hospital, Linkoeping

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 17, 2021

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2030

Study Registration Dates

First Submitted

May 20, 2024

First Submitted That Met QC Criteria

May 24, 2024

First Posted (Actual)

May 30, 2024

Study Record Updates

Last Update Posted (Actual)

May 30, 2024

Last Update Submitted That Met QC Criteria

May 24, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 218/443-31

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Data sharing will only be within investigators. Beyond study investigators data sharing requires new ethical approval.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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