Quality of Life 4: Long-term cardiological and psychosocial outcome in adults operated for congenital heart disease in early childhood: a longitudinal cohort-study of 40-53 years of follow-up.

Quality of Life 4: Long-term cardiological and psychosocial outcome in adults operated for congenital heart disease in early childhood: a longitudinal cohort-study of 40-53 years of follow-up. - Quality of Life 4 - QoL4

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON48379

Enrollment

342

Registered

2019-11-13

Start date

2020-01-01

Completion date

Unknown

Last updated

2024-04-15

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

Conditions

Grown-up Congenital Heart disease patients born with a heart defect

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients who underwent cardiac surgery in Rotterdam between 1968 and 1980 becuase of atrial septum defect, ventricular septal defect, tetralogy of Fallot, transposition of the great arteries and pulmonary stenosis. At the moment of surgery they were 15 years or younger. Singned informed conseent.

Exclusion criteria

Exclusion criteria: Patients who were older then 15 years at the moment of surgery Patients who received a palliative shunt No informed consent Patients who do not speak the Dutch language Patients who have renal insufficiency (eGF

Design outcomes

Primary

Measure	Time frame
Cardiac outcomes: 1. To describe the life expectancy in patients who underwent corrective surgery below the age of 15 years because of a congenital heart defect after 40 to 53 years. Psychological outcomes: 1. To describe the quality of life and psychological functioning in this cohort and to compare it with a healthy control population.	—

Secondary

Measure	Time frame
Cardiac outomes: a. Anamnesis, prevalence of complaints of cardiac failure (NYHA class), rhythm disorders, daily functioning. Prevalence of cardiovascular risk factors. A standardized questionnaire will be used. b. Physical examination (length and weight, bloodpresure, pulse, O2 sat, auscultation, CVP) c. Echocardiographic parameters (2D, 3D, PW, CW Doppler, color Doppler, tissue Doppler, high frame rate) 3. Echocardiographic parameters (2D, 3D, PW en CW Doppler, color Doppler, tissue Doppler, high frame rate echocardiography) 4. MRI parameters (MRI with contrast) 5. VO2 max 6. ECG parameters 7. Holter (24 hours) 8. Laboratory results (vena punction) Psychologisch: 1. psychosocial outcome: daily activity, occupational status, sick leave, career possibilities, application and benefit of social security, (sexual) relationships, marital status, offspring. 2. Sexual functioning: erectile function: international index of erectile function (IIEF), knowledge and fears as to sexual behaviours, anticonception, pregnancy, delivery, menopause. 3. emotional functioning: psychopathology, self esteem. 4. social functioning 5. health related life styles 6. perception of severity of congenital heart disease. 7. End of life issues	—

Measure

Time frame

Cardiac outomes: a. Anamnesis, prevalence of complaints of cardiac failure (NYHA class), rhythm disorders, daily functioning. Prevalence of cardiovascular risk factors. A standardized questionnaire will be used. b. Physical examination (length and weight, bloodpresure, pulse, O2 sat, auscultation, CVP) c. Echocardiographic parameters (2D, 3D, PW, CW Doppler, color Doppler, tissue Doppler, high frame rate) 3. Echocardiographic parameters (2D, 3D, PW en CW Doppler, color Doppler, tissue Doppler, high frame rate echocardiography) 4. MRI parameters (MRI with contrast) 5. VO2 max 6. ECG parameters 7. Holter (24 hours) 8. Laboratory results (vena punction) Psychologisch: 1. psychosocial outcome: daily activity, occupational status, sick leave, career possibilities, application and benefit of social security, (sexual) relationships, marital status, offspring. 2. Sexual functioning: erectile function: international index of erectile function (IIEF), knowledge and fears as to sexual behaviours, anticonception, pregnancy, delivery, menopause. 3. emotional functioning: psychopathology, self esteem. 4. social functioning 5. health related life styles 6. perception of severity of congenital heart disease. 7. End of life issues

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Countries

Netherlands

Outcome results