Telemedical monitoring in the heart failure network by a heart failure nurse using health trackers

Telemedical monitoring in the heart failure network by a heart failure nurse using health trackers - HANSE HF-STEPS PILOT STUDY

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00040209

Enrollment

200

Registered

2026-05-07

Start date

2022-08-24

Completion date

Unknown

Last updated

2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

I50.1

Interventions

Group 1: Telemedical Follow-up by Heart Failure Nurse In addition to routine outpatient care (according to disease severity and at the discretion of the treating cardiologist) at the university outpa

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Heart failure with a resulting functional NYHA class II–III. 2. Left ventricular ejection fraction (LVEF) between 15–40% as assessed by echocardiography, or LVEF =40% with NT-proBNP =125 pg/ml. 3. Hospitalization or outpatient emergency visit due to cardiac decompensation with the need for intensified diuretic therapy within the last 12 months prior to randomization. 4. Patient has been discharged and is able to live in an outpatient setting with functional NYHA class II–III. 5. Adequate control of arrhythmias with a heart rate 1 year. 7. Ability to use a smartphone for installation and operation of a health application (e.g., Withings app). 8. Ability to fluently understand and speak the language in which the study is conducted. 9. Ability to understand and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Allergy to rubber or latex 2. Inability to perform a 6-minute walk test 3. Any other condition that, in the opinion of the investigator, prevents the use of a health tracker or interferes with the conduct of the study

Design outcomes

Primary

Measure	Time frame
Time expenditure of care, quantified by the number of telephone contacts per patient conducted by a Heart Failure Nurse over a 12-month period	—

Secondary

Measure	Time frame
Heart failure hospitalization due to cardiac decompensation within 12 months All-cause mortality within 12 months Total number of hospitalizations within 12 months Change in quality of life within 12 months (EQ-5D) Proportion of guideline-recommended heart failure medication within 12 months	—

Countries

Germany

Contacts

Public ContactChristina Paitazoglou

Medizinische Klinik II - Kardiologie, Angiologie und Intensivmedizin

christina.paitazoglou@uksh.de0451 500 77066

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Jun 11, 2026