## Protocol Section
### Identification Module
**NCT ID:** NCT06435585

**Acronym:** Responders

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

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

#### Organization Study ID Info
**ID:** 218/443-31
#### Organization
**Class:** OTHER
**Full Name:** Karolinska University Hospital
### Status Module
#### Completion Date
**Date:** 2030-12-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-24

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2030-12-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2021-02-17

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** University Hospital, Linkoeping

#### Lead Sponsor

**Class:** OTHER

**Name:** Karolinska University Hospital

#### Responsible Party

**Investigator Affiliation:** Karolinska University Hospital

**Investigator Full Name:** Camilla Hage

**Investigator Title:** Associate Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** A biobank within the Swedish national heart failure quality registry SwedeHF.

**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.

### Conditions Module

**Conditions:**

- Heart Failure

- Pathophysiology

### Design Module

#### Bio Spec

**Description:** Plasma, serum, whole blood, urine

**Retention:** SAMPLES_WITH_DNA

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 5000

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Outcomes Module

#### Primary Outcomes

**Description:** To identify which patient will be a non-responder resulting in a poor outcome, despite being on recommended treatment according to guidelines.

**Measure:** Identify responders to guideline-directed medical therapy

**Time Frame:** 2 and 5 years

**Description:** To characterize differences between responders and non-responders in terms of morbidity after 2-years follow-up.

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

**Time Frame:** 2 years

**Description:** To characterize differences between responders and non-responders in terms of mortality after 2-years follow-up.

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

**Time Frame:** 2 years

**Description:** To integrate information regarding clinical characteristics, diagnostic markers and genetics to determine underlying mechanisms behind different responses to treatment.

**Measure:** Predictors of responders and non-responders to guideline-directed medical therapy

**Time Frame:** 2 and 5 years

#### Secondary Outcomes

**Description:** To evaluate the differences between HFrEF and HFpEF patients in terms of mortality and after 2 and 5 years follow-up, respectively.

**Measure:** Differences between responders and non-responders regarding mortality

**Time Frame:** 2 and 5 years

**Description:** o evaluate the differences between HFrEF and HFpEF patients in terms of morbidity after 2 and 5 years follow-up, respectively.

**Measure:** Differences between responders and non-responders regarding morbidity

**Time Frame:** 2 and 5 years

**Description:** 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.

**Measure:** Predictors of mortality in responders and non-responders

**Time Frame:** 2 and 5 years

**Description:** 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.

**Measure:** Predictors of morbidity in responders and non-responders

**Time Frame:** 2 and 5 years

### Eligibility Module

**Eligibility Criteria:** 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.

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** PAtients with heart failure in Sweden with a registration in SwedeHF.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** camilla.hage@regionstockholm.se

**Name:** Camilla Hage, Ass prof

**Phone:** +46 (0)703340660

**Role:** CONTACT

**Contact 2:**

**Email:** ulf.dahlstrom@liu.se

**Name:** Ulf Dahlström, Prof

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Stockholm

**Contacts:**

***Contact 1:***

- **Email:** camilla.hage@regionstockholm.se

- **Name:** Camilla Hage, Ass prof

- **Phone:** +46 (0)703340660

- **Role:** CONTACT

***Contact 2:***

- **Name:** Ulf Dahlström, MD, Prof

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 3:***

- **Name:** Erik Ostgärd Thunstrom, MD, Ass prof

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 4:***

- **Name:** Christina Christersson, MD, Ass prof

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 5:***

- **Name:** Martin Magnusson, MD, Prof

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 6:***

- **Name:** Barna Szabo, MD

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 7:***

- **Name:** Therese Andersson, MD, PhD

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 8:***

- **Name:** Carin Cabrera, MD, PhD

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 9:***

- **Name:** Patric Karlstrom, MD, PhD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Sweden

**Facility:** Karolinska University hospital

**Status:** RECRUITING

**Zip:** 17164

### IPD Sharing Statement Module

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

**IPD Sharing:** UNDECIDED

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000006331

- Term: Heart Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M9421

- Name: Heart Failure

- Relevance: HIGH

- As Found: Heart Failure

- ID: M9419

- Name: Heart Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000006333

- Term: Heart Failure

### Misc Info Module

- Version Holder: 2024-05-31
