CARNA - Evaluation study to assess medical benefits and positive care effects of app-based, guideline-compliant patient support in heart failure

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00027949

Enrollment

450

Registered

2022-03-17

Start date

2022-03-21

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

I50

Interventions

Group 1: Use of ProHerz Group 2: standard-of-care

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: ? Diagnosed heart failure (ICD code I50.-) ? NYHA- Stadium I, NYHA- Stadium II, NYHA-Stadium III ? EF 500 ? Age =18 years ? Ability to speak and read in German. ? Ability to use an application running on a smartphone or other mobile device. ? Informed consent of the study participant.

Exclusion criteria

Exclusion criteria: ? Not owning a smartphone or mobile device with internet access. ? Cognitive impairment with the inability to give consent to the protocol. ? Inability or unwillingness to complete app use (e.g. blindness, inadequate German language skills, limited informal self-determination) ? NYHA IV stage (I50.05 Right heart failure with symptoms at rest NYHA stage IV; I50.14 With symptoms at rest NYHA stage IV) ? Hospitalisation within the last 8 weeks before inclusion ? Condition after implantation of a mechanical cardiac assist system ? Acute coronary syndrome (troponin = 5 x ULN (Upper Limit of Normal)) within the last 8 weeks before inclusion ? High urgent HTX listing ? Planned revascularisation, TAVI, mitral clip, etc. ? Revascularisation and/or CRT implantation within the last 3 months ? Chronic drug or alcohol abuse as assessed by the physician. ? Terminal renal failure with haemodialysis treatment (ICD code N18.5) ? Diseases with a life expectancy of < 12 months ? Pregnancy ? Wheelchair use ? Participation in other intervention studies or other telemedicine programmes ? Participation in the CARNA pretest study. ? No valid Corona proof (depending on the regulations of the study centre) at the inclusion examination

Design outcomes

Primary

Measure	Time frame
? Change in the 6-minute walk test ? Change in EQ-5D-5L Index ? Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Index ? Change in the 9-item European Heart Failure Self-care Behaviour Scale (G9-EHFScBS) ? Change in NYHA classification	—

Secondary

Measure	Time frame
? Difference in 9-item Shared Decision-Making Questionnaire (SDM-Q-9) score. ? Difference in the Atlanta Heart Failure Knowledge Test (AHFKT). ? Difference in self-reported use of outpatient and inpatient health care.	—

Countries

Germany

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026