Ignite Creation Date:
2024-05-06 @ 3:39 AM
Last Modification Date:
2024-10-26 @ 11:37 AM
Study NCT ID:
NCT02347540
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2022-07-28
First Post:
2014-12-30
Brief Title:
Heart Failure and Related Risk-factors After Preeclampsia
Sponsor:
Maastricht University Medical Center
Organization:
Maastricht University Medical Center
Study Overview
Official Title:
Queen of Hearts Research Program Identifying the Risk on Heart Failure After Preeclampsia
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2022-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
QoH
Brief Summary:
This study is a cross-sectional case-control study where classical as well as more innovative risk factors for CVD will be explored
In western countries more women than men die of cardiovascular disease CVD making CVD in women an important public health issue Misdiagnosis of CVD in women is frequently observed posing the clinician for diagnostic and therapeutic dilemmas that can easily result in inadequate treatment and worse prognosis Despite these challenges CVD in women has been underexposed in scientific research
Women have gender-specific risk factors like a history of preeclampsia PE that contribute to their risk for CVD PE complicates 5-10 of pregnancies recurs in 25 and is associated with a 2-4 fold increased risk for CVD Moreover pre-symptomatic heart failure HF stage B occurs in 40 of women with a history of PE HF stage B is thought to precede the development of the mortality related clinical HF stages C and D structural heart disease in combination with symptomatic disease Early detection and tailored intervention of women with stage B HF decreases progression to the clinical stages and might therefore improve clinical outcome and cardiovascular related mortality
Phenotypic presentation of HF is currently split up between systolic HF also called HF with reduced ejection fraction HFrEF and diastolic HF or HF with preserved ejection fraction HFpEF Women more often have HFpEF in contrast to men Different pathophysiology and disease progression in women compared to men seems to be an important underlying factor The current clinical HF diagnostic tools eg natriuretic hormones and high sensitivity troponins fail to identify early changes that prelude adverse cardiac remodelling and HF and do not discriminate between HFrEF and HFpEF Moreover there are sex-related differences in biomarker levels for detection of CVD As a result clinicians are forced to wait for the failing heart to become clinically evident before they can intervene Therefore there is an urgent need to assess novel biomarkers that could help select high risk women needing further follow up and intervention Biomarkers may not only improve early diagnosis but may also unravel disease pathways of HFpEF Especially when combined with measurements of subclinical surrogate risk markers
Objectives
To determine the impact of PE on incidence of macro-and micro-vascular dysfunction reflected by surrogate measures for coronary artery disease CAD and HFpEF
To perform a genome wide association study GWAS and associate novel biomarker expression levels with endothelial function cardiac diastolic function and IMT measurement
To identify risk factors and surrogate measures for CVD in a former PE patients without HFpEF b former PE patients with HFpEF and c healthy parous controls
Study population Cases women with a history of PE Controls women with uncomplicated pregnancies in the history Measurements will be performed in clusters at postpartum intervals of ½-2 5-10 10-15 and 15-30 years Number of inclusions will be 425 350 282 and 233 for each follow-up group respectively
Primary endpoints The prevalence of macro- and microvascular dysfunction in former PE patients Novel biomarker detection in former PE patients associated with HF in general and HFpEF in particular
Secondary endpoints
Lifestyle questionnaire
Cognitive ability questionnaire
Depression score questionnaire
Metabolic syndrome MetS
Arterial endothelial function Flow mediated dilation FMD
Intima Media Thickness IMT
Glycocalyx thickness by means of the Glycocheck
Venous function plethysmograph
Electrocardiogram ECG
Ergometry
In western countries more women than men die of cardiovascular disease CVD making CVD in women an important public health issue Misdiagnosis of CVD in women is frequently observed posing the clinician for diagnostic and therapeutic dilemmas that can easily result in inadequate treatment and worse prognosis Despite these challenges CVD in women has been underexposed in scientific research
Women have gender-specific risk factors like a history of preeclampsia PE that contribute to their risk for CVD PE complicates 5-10 of pregnancies recurs in 25 and is associated with a 2-4 fold increased risk for CVD Moreover pre-symptomatic heart failure HF stage B occurs in 40 of women with a history of PE HF stage B is thought to precede the development of the mortality related clinical HF stages C and D structural heart disease in combination with symptomatic disease Early detection and tailored intervention of women with stage B HF decreases progression to the clinical stages and might therefore improve clinical outcome and cardiovascular related mortality
Phenotypic presentation of HF is currently split up between systolic HF also called HF with reduced ejection fraction HFrEF and diastolic HF or HF with preserved ejection fraction HFpEF Women more often have HFpEF in contrast to men Different pathophysiology and disease progression in women compared to men seems to be an important underlying factor The current clinical HF diagnostic tools eg natriuretic hormones and high sensitivity troponins fail to identify early changes that prelude adverse cardiac remodelling and HF and do not discriminate between HFrEF and HFpEF Moreover there are sex-related differences in biomarker levels for detection of CVD As a result clinicians are forced to wait for the failing heart to become clinically evident before they can intervene Therefore there is an urgent need to assess novel biomarkers that could help select high risk women needing further follow up and intervention Biomarkers may not only improve early diagnosis but may also unravel disease pathways of HFpEF Especially when combined with measurements of subclinical surrogate risk markers
Objectives
To determine the impact of PE on incidence of macro-and micro-vascular dysfunction reflected by surrogate measures for coronary artery disease CAD and HFpEF
To perform a genome wide association study GWAS and associate novel biomarker expression levels with endothelial function cardiac diastolic function and IMT measurement
To identify risk factors and surrogate measures for CVD in a former PE patients without HFpEF b former PE patients with HFpEF and c healthy parous controls
Study population Cases women with a history of PE Controls women with uncomplicated pregnancies in the history Measurements will be performed in clusters at postpartum intervals of ½-2 5-10 10-15 and 15-30 years Number of inclusions will be 425 350 282 and 233 for each follow-up group respectively
Primary endpoints The prevalence of macro- and microvascular dysfunction in former PE patients Novel biomarker detection in former PE patients associated with HF in general and HFpEF in particular
Secondary endpoints
Lifestyle questionnaire
Cognitive ability questionnaire
Depression score questionnaire
Metabolic syndrome MetS
Arterial endothelial function Flow mediated dilation FMD
Intima Media Thickness IMT
Glycocalyx thickness by means of the Glycocheck
Venous function plethysmograph
Electrocardiogram ECG
Ergometry
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2013T084 | OTHER_GRANT | Nederlandse Hartstichting Dutch Heart Foundation | None |