NCT04129658

Brief Summary

The aim of the study is to optimize diagnosis and treatment for patients with heart failure in Swedish primary care. Patient with the diagnose heart failure registered in the electronic medical record (EMR) at seventeen primary health care centers (PHCCs) will be invited to to participate in the study. Blood testing and electrocardiography will be performed. Data on diagnosis and medical treatment will be collected from the EMR. An educational visit with a cardiologist will be performed at the PHCC, in order to discuss evidence-based diagnoses and treatment of heart failure. Data on drug therapy and health care consumption will be collected after six and twelve months.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
563

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 15, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 17, 2019

Completed
1.6 years until next milestone

Study Start

First participant enrolled

May 26, 2021

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2024

Completed
Last Updated

February 29, 2024

Status Verified

February 1, 2024

Enrollment Period

2.7 years

First QC Date

October 15, 2019

Last Update Submit

February 27, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Medication change

    Change in proportion of patients treated with the combination angiotensin conversion enzyme-inhibitors(ACEi) or angiotensin receptor blockers (ARB) and betablockers

    6 months after inclusion

Secondary Outcomes (4)

  • Change in health care consumption

    One year after the intervention

  • Change in mortality rate

    One year after the intervention

  • Change in medication

    Six months after the intervention

  • Change in diagnostics

    Six months after the intervention

Study Arms (2)

Intervention

The patients are registered at PHCCs who agreed to participate into the study, the patients have provided an informed consent. The PHCCs (seventeen according to the power calculation) will receive an educational outreach visit by a cardiologist, discussing evidence-based treatment. The physician will decide afterwords if the treatment will be adjusted. Blood samples and electrocardiography will be collected before the intervention, data from the EMR will be collected before and after the intervention.

Behavioral: Educational outreach visit

Control

The control group will be the rest of the patients with heart failure in Southern Sweden. Data from the regional data base on medication and heath care consumption will be collected at base line and 6 and 12 months after.

Interventions

Two-four hours of discussion between a cardiologist and the primary care physicians at the PHCC encompassing evidence-based treatment guidelines and counseling upon specific patient cases and their diagnose and treatment for congestive heart failure.

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients who meet the inclusion criteria and left informed consent, at Swedish PHCCs that have previously agreed to participate in the study. All invited PHCCs are located in the Region of Skane, Southern Sweden.

You may qualify if:

  • patients with ICD diagnose I50, I11.0, I42 and I43 in the electronic medical journal and who have left informed consent to participate in the study

You may not qualify if:

  • patients with ICD diagnose I42.1, I42.2
  • patients where the heart failure diagnose is set on wrong grounds according to the information in the electronic medical journal, as normal NT-proBNP or/and normal ecocardiogram.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vårdcentralen Granen

Malmo, Sweden

Location

Related Publications (1)

  • Svensson Soderberg K, Kronestedt Lundevall L, Lindow T, O Braun O, Smith JG, Sundquist K, Milos Nymberg V. Heart failure in Southern Sweden (HISS): a cross-sectional analysis of primary care patients' characteristics and physicians' adherence to guideline-directed medical therapy. BMJ Open. 2025 Nov 4;15(11):e101178. doi: 10.1136/bmjopen-2025-101178.

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 15, 2019

First Posted

October 17, 2019

Study Start

May 26, 2021

Primary Completion

January 31, 2024

Study Completion

January 31, 2024

Last Updated

February 29, 2024

Record last verified: 2024-02

Locations