Heart FailureQoHNCT02347540
Heart Failure and Related Risk-factors After Preeclampsia
An observational study of Heart Failure and Cardiovascular Diseases, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Heart Failure, Cardiovascular Diseases, Pre-Eclampsia
- How many people
- 2,580 participants
- Where
- 1 siteNetherlands
- Study dates
- Dec 2014to Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Cases: women with a history of PE. Control group: women with uncomplicated pregnancies in the history H1: PP interval ½ -2 years: n = 2x 425 H2: PP interval 5-10 years: n = 2x 350 H3: PP interval 10-15 years: n = 2x 282 H4: PP interval 15-30 years: n = 2x 233
Who may be able to join
- Cases
- Women aged ≥ 18 years
- ½ till 30 years after the complicated pregnancy
- Experienced PE in any pregnancy. PE defined as hypertension (systolic BP ≥ 140 mmHg and/or diastolic BP ≥ 90 mmHg) developed after 20 weeks of pregnancy with the development of proteinuria (≥ 300 mg/ 24 hours).
- Women who had their last delivery at least 6 months ago.
- Controls
Show all 11Show fewer
- Women aged ≥ 18 years
- ½ till 30 years after the pregnancy that matches the sequence number of pregnancy of the specifically matched case.
- Experienced pregnancies that were not complicated by foetal or maternal placental syndrome (pregnancy induced hypertension, preeclampsia, HELLP-syndrome).
- Women who had their last pregnancy at least 6 months ago.
- Women with a negative family history for PE (mother and sisters did not experience PE).
Who cannot join
- A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Cases
- Women with auto-immune diseases prior to the complicated pregnancy.
- Chronic hypertension prior to the complicated pregnancy.
- Renal disease prior to the complicated pregnancy.
- Pregnant women
Show all 14Show fewer
- Women who do not want to be informed about the results of the tests, or women who do not want their general practitioner and specialist(s) to be informed about the test results.
- Control group:
- Women with auto-immune diseases
- Chronic hypertension prior to the matched pregnancy.
- Women with IUGR in the matching pregnancy (p<10)
- Solutio placentae in the matching pregnancy
- Pregnant women
- Women who do not want to be informed about the results of the tests, or women who do not want their general practitioner and specialist(s) to be informed about the test results.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht University Medical Center
Maastricht, Limburg, 6202 AZ
About this study
Official title: Queen of Hearts Research Program. Identifying the Risk on Heart Failure After Preeclampsia.
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.
Read more
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 (e.g. 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
- Conditions
- Heart Failure, Cardiovascular Diseases, Pre-Eclampsia
- Keywords
- Heart Failure, Diastolic Dysfunction, Pre-Eclampsia, Endothelial dysfunction, Biological Markers, MicroRNAs, Circulating cells
- Medical subject headings
- Heart Failure, Cardiovascular Diseases, Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Women with a history of preeclampsia (cases) | Cases: women with a history of preeclampsia. Measurements will be performed in a postpartum interval from 0.5 years until 30 years after the first complicated pregnancy. This group will further be subdivided in a subgroup with Heart Failure and a group without Heart Failure. | |
| Women with a history of uncomplicated pregnancy (controls) | Controls include women with a history of uncomplicated pregnancies. The controlgroup will further be subdivided in a subgroup with Heart Failure and a group without Heart Failure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The prevalence of Heart Failure (number with percentage)
Heart Failure will be assessed with the transthoracic echocardiography based on the criteria of the American Heart Association. The sub classification for Heart Failure with preserved ejection fraction (EF) will be made (EF >55%)
Measured: At time of assessment
Secondary outcomes (6)
Structural en Functional Cardiac Measurements
The objective is to estimate structural and functional cardiac measurements with the TTE based on the ASA guidelines.
Measured: At time of assessment
Metabolic syndrome
The objective is to assess the prevalence of constituents of the Metabolic syndrome based on the WHO criteria. The prevalence will be reported in number with percentage.
Measured: At time of assessment
Arterial endothelial function (Flow mediated dilation (FMD))
The objective is to estimate NO mediated endothelial function of the brachial artery with ultrasound by FMD and sublingual NTG administration. FMD will be reported in relative increase in diameter (%).
Measured: At time of assessment
Common Carotid Intima media thickness
The objective is to estimate IMT of the common carotid artery in cm using ultrasound.
Measured: At time of assessment
Glycocalyx thickness en microvascular tortuosity
The objective is to estimate the glycocalyx dimensions using sublingual orthogonal polarization spectral (OPS) measurements. Derivative of the glycocalyx (perfused boundary region) will be reported in um. Tortuosity will be reported based on a score system.
Measured: At time of assessment
Cognitive, Lifestyle and Depression rates
To evaluate subjective cognitive functioning and depression rates and lifestyle behavior in formerly preeclamptic women with heart failure compared to controls.
Measured: At time of assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2015 (estimated)
- Study startDec 2014
- Primary completionDec 2024 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 2,580 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- UMC Utrecht, Leiden University Medical Center, University Medical Center Groningen, Amsterdam UMC, location VUmc, Dutch Heart Foundation
- Responsible party
- Sponsor
- Investigators
- Marc EA Spaanderman, MD, PhD, Study chair, Maastricht University Medical CenterGerard Pasterkamp, PhD, Study chair, UMC UtrechtHester HM den Ruijter, PhD, Study chair, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02347540
- Sponsor's protocol ID
- METC 14-02-013
- Other IDs
- 2013T084
- Acronym
- QoH
- Status last verified
- Jul 2022
- First submitted
- 30 Dec 2014
- Last updated
- 28 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Brandt Y, Alers RJ, Canjels LPW, Jorissen LM, Jansen G, Janssen EBNJ, van Kuijk S, Went TM, Koehn D, Gerretsen SC, Jansen J, Backes W, Hurks PPM, van de Ven V, Kooi ME, Spaanderman MEA, Ghossein-Doha C. DEcreased Cognitive functiON, NEurovascular CorrelaTes and myocardial changes in women with a history of pre-eclampsia (DECONNECT): research protocol for a cross-sectional pilot study. BMJ Open. 2024 Mar 4;14(3):e077534. doi: 10.1136/bmjopen-2023-077534.
PubMed 38443087Mohseni-Alsalhi Z, B N J Janssen E, Delmarque J, van Kuijk SMJ, Spaanderman MEA, Ghossein-Doha C. Prediction Model Based on Easily Available Markers for Aberrant Cardiac Remodeling in Women After Pregnancy. Hypertension. 2023 Aug;80(8):1707-1715. doi: 10.1161/HYPERTENSIONAHA.122.19187. Epub 2023 Jan 25.
PubMed 37470772Alers RJ, Ghossein-Doha C, Canjels LPW, Muijtjens ESH, Brandt Y, Kooi ME, Gerretsen SC, Jansen JFA, Backes WH, Hurks PPM, van de Ven V, Spaanderman MEA. Attenuated cognitive functioning decades after preeclampsia. Am J Obstet Gynecol. 2023 Sep;229(3):294.e1-294.e14. doi: 10.1016/j.ajog.2023.02.020. Epub 2023 Feb 28.
PubMed 36863645Janssen EBNJ, Hooijschuur MCE, Lopes van Balen VA, Morina-Shijaku E, Spaan JJ, Mulder EG, Hoeks AP, Reesink KD, van Kuijk SMJ, Van't Hof A, van Bussel BCT, Spaanderman MEA, Ghossein-Doha C. No accelerated arterial aging in relatively young women after preeclampsia as compared to normotensive pregnancy. Front Cardiovasc Med. 2022 Jul 28;9:911603. doi: 10.3389/fcvm.2022.911603. eCollection 2022.
PubMed 35966519
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Queen of Hearts Research Program. Identifying the Risk on Heart Failure After Preeclampsia.
- ClinicalTrials.gov ID
- NCT02347540
- Acronym / sponsor ID
- QoH / METC 14-02-013
- Conditions
- Heart Failure, Cardiovascular Diseases, Pre-Eclampsia
- Keywords
- Heart Failure, Diastolic Dysfunction, Pre-Eclampsia, Endothelial dysfunction, Biological Markers, MicroRNAs, Circulating cells
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,580 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- UMC Utrecht, Leiden University Medical Center, University Medical Center Groningen, Amsterdam UMC, location VUmc, Dutch Heart Foundation
- Study start
- Dec 2014 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 27 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 (e.g. 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
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Women with a history of preeclampsia (cases) | – | –Cases: women with a history of preeclampsia. Measurements will be performed in a postpartum interval from 0.5 years until 30 years after the first complicated pregnancy. This group will further be subdivided in a subgroup with Heart Failure and a group without Heart Failure. |
| Women with a history of uncomplicated pregnancy (controls) | – | –Controls include women with a history of uncomplicated pregnancies. The controlgroup will further be subdivided in a subgroup with Heart Failure and a group without Heart Failure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Cases: women with a history of PE. Control group: women with uncomplicated pregnancies in the history H1: PP interval ½ -2 years: n = 2x 425 H2: PP interval 5-10 years: n = 2x 350 H3: PP interval 10-15 years: n = 2x 282 H4: PP interval 15-30 years: n = 2x 233
Key inclusion criteria (11 listed)
- Cases
- Women aged ≥ 18 years
- ½ till 30 years after the complicated pregnancy
- Experienced PE in any pregnancy. PE defined as hypertension (systolic BP ≥ 140 mmHg and/or diastolic BP ≥ 90 mmHg) developed after 20 weeks of pregnancy with the development of proteinuria (≥ 300 mg/ 24 hours).
- Women who had their last delivery at least 6 months ago.
Key exclusion criteria (14 listed)
- A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Cases
- Women with auto-immune diseases prior to the complicated pregnancy.
- Chronic hypertension prior to the complicated pregnancy.
- Renal disease prior to the complicated pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The prevalence of Heart Failure (number with percentage)
Time frame: At time of assessment
Heart Failure will be assessed with the transthoracic echocardiography based on the criteria of the American Heart Association. The sub classification for Heart Failure with preserved ejection fraction (EF) will be made (EF >55%)
6 secondary outcomes
Structural en Functional Cardiac Measurements
Time frame: At time of assessment
Metabolic syndrome
Time frame: At time of assessment
Arterial endothelial function (Flow mediated dilation (FMD))
Time frame: At time of assessment
Common Carotid Intima media thickness
Time frame: At time of assessment
Glycocalyx thickness en microvascular tortuosity
Time frame: At time of assessment
Cognitive, Lifestyle and Depression rates
Time frame: At time of assessment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2022.
- Derived from this study: PubMed 38443087Brandt Y, Alers RJ, Canjels LPW, Jorissen LM, Jansen G, Janssen EBNJ, van Kuijk S, Went TM, Koehn D, Gerretsen SC, Jansen J, Backes W, Hurks PPM, van de Ven V, Kooi ME, Spaanderman MEA, Ghossein-Doha C. DEcreased Cognitive functiON, NEurovascular CorrelaTes and myocardial changes in women with a history of pre-eclampsia (DECONNECT): research protocol for a cross-sectional pilot study. BMJ Open. 2024 Mar 4;14(3):e077534. doi: 10.1136/bmjopen-2023-077534.
- Derived from this study: PubMed 37470772Mohseni-Alsalhi Z, B N J Janssen E, Delmarque J, van Kuijk SMJ, Spaanderman MEA, Ghossein-Doha C. Prediction Model Based on Easily Available Markers for Aberrant Cardiac Remodeling in Women After Pregnancy. Hypertension. 2023 Aug;80(8):1707-1715. doi: 10.1161/HYPERTENSIONAHA.122.19187. Epub 2023 Jan 25.
- Derived from this study: PubMed 36863645Alers RJ, Ghossein-Doha C, Canjels LPW, Muijtjens ESH, Brandt Y, Kooi ME, Gerretsen SC, Jansen JFA, Backes WH, Hurks PPM, van de Ven V, Spaanderman MEA. Attenuated cognitive functioning decades after preeclampsia. Am J Obstet Gynecol. 2023 Sep;229(3):294.e1-294.e14. doi: 10.1016/j.ajog.2023.02.020. Epub 2023 Feb 28.
- Derived from this study: PubMed 35966519Janssen EBNJ, Hooijschuur MCE, Lopes van Balen VA, Morina-Shijaku E, Spaan JJ, Mulder EG, Hoeks AP, Reesink KD, van Kuijk SMJ, Van't Hof A, van Bussel BCT, Spaanderman MEA, Ghossein-Doha C. No accelerated arterial aging in relatively young women after preeclampsia as compared to normotensive pregnancy. Front Cardiovasc Med. 2022 Jul 28;9:911603. doi: 10.3389/fcvm.2022.911603. eCollection 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc EA Spaanderman, MD, PhD study chair
Maastricht University Medical Center
Gerard Pasterkamp, PhD study chair
UMC Utrecht
Hester HM den Ruijter, PhD study chair
UMC Utrecht
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Cardiovascular Diseases, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The prevalence of Heart Failure (number with percentage) (time frame: At time of assessment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02347540, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2022; AzTrials last refreshed its copy on 7 Nov 2026.