Cross-sectional study to assess the health-related quality of life in patients with complex univentricular heart defects after Fontan surgery

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00023120

Enrollment

200

Registered

2020-11-05

Start date

2020-09-03

Completion date

Unknown

Last updated

2026-01-12

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

Conditions

Q20.4 Q22.4 Q23.4

Interventions

Group 1: All german-speaking Fontan patients aged at least 5 years and currently followed in the German Heart Center Berlin (DHZB). The health-related quality of life questionnaire PedsQL, completed d

Eligibility

Sex/Gender

All

Age

3 Years to No maximum

Inclusion criteria

Inclusion criteria: All german-speaking Fontan-patients of at least 5 years of Age that are followed in the DHZB and will have completed the PedsQL questionnaire.

Exclusion criteria

Exclusion criteria: none

Design outcomes

Primary

Measure	Time frame
The objective of the study is to asess the health-related quality of life in Fontan-patients of all age groups in our follow-up program. The main aim is to quantify the extent of impairment of quality of life in these chronically ill patients and which domains are primarily affected.	—

Secondary

Measure	Time frame
Objective cardiopulmonary capacity in correlation to subjective health-related quality of life	—

Countries

Germany

Contacts

Public ContactPeter Kramer

Deutsches Herzzentrum Berlin

kramerpeter@dhzb.de03045932800

Outcome results

None listed

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