Brief Summary

In the Swedish registry for congenital heart defects, SWEDCON, over 230 patients with single-ventricle circulation are registered in the adult section. Congenital heart defects affect career choices, family planning, and leisure activities. Questions regarding heredity and pregnancy are common. The impact of Fontan circulation on reproductive health and fertility needs to be illuminated, and additional studies are required from both medical and psychosocial perspectives.Cognitive impairment is common among patients with congenital heart defects but is likely an overlooked cause of long-term illness. Objective To study a large national population (n=200) of adults with Fontan circulation and their potential partners regarding.

the prevalence and explanatory factors for sexual dysfunction and infertility in women and men with Fontan circulation (Study A).
the outcomes of pregnancy, choice of delivery mode, and complications in patients with Fontan circulation (Study B).
the experiences and perceptions of becoming parents among women (n=20) and men (n=20), as well as elucidate reasoning and family planning among women and men (n=20) who have not become parents (Study C).
Investigate the prevalence and explanatory factors for (Sub-study D):
Fatigue
In-depth cognitive screening to describe specific cognitive functions such as auditory memory, visuospatial memory, attention, cognitive speed, and executive functions. The aim of this research is to gain more knowledge in an area that has been relatively underexplored, thus improving care for women and men with congenital heart defects.

Trial Health

On Track

Trial Health Score

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

Enrollment

600

participants targeted

Target at P75+ for all trials

Timeline

5mo left

Started Nov 2023

Typical duration for all trials

Geographic Reach

1 country

15 active sites

Status

recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

2.9 years study duration

Study Progress86%

Nov 2023Oct 2026

Study Start

First participant enrolled

November 1, 2023

Completed

3 months until next milestone

First Submitted

Initial submission to the registry

February 6, 2024

Completed

8 days until next milestone

First Posted

Study publicly available on registry

February 14, 2024

Completed

1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Expected

Last Updated

October 16, 2024

Status Verified

October 1, 2024

Enrollment Period

1.9 years

First QC Date

February 6, 2024

Last Update Submit

October 11, 2024

Conditions

Fontan Circulation

Keywords

reproductive healthcognitive impairmentgrown up heart disease

Outcome Measures

Primary Outcomes (1)

Prevalence and explanatory factors for sexual dysfunction and infertility in women and men with Fontan circulation
Reproductive health questionnaire for Woman/reproductive health questionnaire for Man, and a questionnaire for the potential partner, designed for this study. International Index of Erectile Function (IIEF5) Female Sexual Function Index (FSFI) EQ-5D is an instrument to describe and measure health and health-related quality of life.
3 hours

Secondary Outcomes (3)

Obstetric, neonatal and cardiological variables before, during, and after pregnancy
4 hours
Experiences and perceptions of parenthood
4 hours
Cognitive function
4 hours

Study Arms (6)

Male with Fontan circulation

Different data will be collected along with several questionnaires concerning reproductive health. Approximate 100 individuals will be included-