Cardiovascular DiseasesNCT05806372
Biomarkers of CVD Dysfunction in Hypertensive Disorders of Pregnancy
An observational study of Cardiovascular Diseases and Pregnancy, run by IRCCS Burlo Garofolo at 1 site in Italy.
Trial summary
Profound and concomitant cardiovascular hemodynamic changes, necessary to support fetoplacental development and its increasing supply demands, occur during a physiological pregnancy characterized by an increase in cardiac output, heart rate and plasma volume, and fall in vascular resistance and blood pressure. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Cardiovascular Diseases, Pregnancy
- How many people
- 128 participants
- Where
- 1 siteItaly
- Study dates
- 15 Oct 2023to 15 Mar 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 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: Singleton pregnant women between 24 and 40 gestational weeks with HDP (with and without fetal growth disorder) and normotensive (controls)
Who may be able to join
- CASES:
- Pregnant women affected by HDP
- Women ≥18 years old
- Women able to give an informed consent
- CONTROLS
- Uneventful pregnancy of women ≥18 years old
- Women able to give an informed consent
Who cannot join
- No informed consent
- Women <18 years old
- Presence of other maternal pathologies as viral disease, diabetes
- Fetal chromosomal/structural anomalies
Trial locations and contacts
1 site in 1 country.
Italy1 site
IRCCS Burlo Garofolo
Trieste, 34137
Tamara Stampalija, MD, +390403785486, tamara.stampalija@burlo.trieste.it
About this study
Official title: Biomarkers of Maternal Cardio-vascular Dysfunction in Pregnancies Complicated by Hypertensive Disorders of Pregnancy
Profound and concomitant cardiovascular hemodynamic changes, necessary to support fetoplacental development and its increasing supply demands, occur during a physiological pregnancy characterized by an increase in cardiac output, heart rate and plasma volume, and fall in vascular resistance and blood pressure. The result of these changes is a volume overload that will lead to a compensatory transient left ventricular eccentric hypertrophy. This, together with the pro-inflammatory state typical of pregnancy, represents the pregnancy as a stress-test for the maternal cardiovascular system. Pregnancies complicated by hypertensive disorders of pregnancy (HDP), particularly those with early onset and/or complicated by intrauterine fetal growth restriction (FGR), are characterized by a cardiovascular maladaptation. Women who experienced HDP in pregnancy, especially pre-eclampsia (PE), more often develop later in life ischemic heart disease, hypertension and stroke, obesity, dyslipidemia, and end-stage renal disease.
Regardless its clinical impact, very little knowledge is available on the mechanisms by which PE could lead to cardiovascular disease (CVD), and, especially, to heart failure after pregnancy. Preliminary results suggest a cross-talk between pregnancy-induced biomarkers and cardio-vascular system. Particularly, cultures of neonatal rat cardiomyocytes and fibroblasts were used to investigate the role of the serum of women with HDP in regulating their proliferation. 5-ethynyl-2'-deoxyuridine (EdU) was administered to label DNA synthesis in proliferating cells. After 3 days of in vitro culture, EdU incorporation was analyzed upon immunofluorescence staining using specific antibodies by high content microscopy. A possible protective effect exerted by the selected sera against apoptosis was evaluated, as well, by Caspase activation. Moreover, the effect of cardiomyocytes and fibroblasts proliferation and apoptosis on maternal hemodynamic parameters was evaluated using median regression models. These data show that the serum of women with HDP triggers a net increase in the percentage of proliferating cardiomyocytes compared to controls. Moreover, there were relationship between cardiomyocytes and fibroblasts proliferation and maternal hemodynamics parameters thus, supporting the hypothesis that the serum of women with HDP may contain factors capable of stimulating cardiac cells in response to the cardiovascular stress-test
- Conditions
- Cardiovascular Diseases, Pregnancy
- Keywords
- Cardiomyocytes, microRNA,, hypertensive disorders of pregnancy
- Medical subject headings
- Cardiovascular Diseases
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 |
|---|---|---|
| HDP with FGR | Evaluation of sera and ultrasound data on fetal growth and Doppler velocimetry in women with HDP and fetal growth restriction. | |
| HDP without FGR | Evaluation of sera and ultrasound data on fetal growth and Doppler velocimetry in women with HDP and without fetal growth restriction. | |
| Normotensive | Evaluation of sera and ultrasound data on fetal growth and Doppler velocimetry in normotensive women. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of biomarkers predicting cardiomyocyte hypertrophy and fibroblast proliferation
By exploiting the availability of a library of viral vectors encoding for the whole secretome (about 1200 secreted proteins) and the whole miRNAome (about 2000 human microRNAs) a high throughput screening will be carried out to identify molecules able to control the viability, proliferation and cell size of both primary cardiomyocytes and cardiac fibroblasts. Data mining methods for multi-target prediction, such as ensembles of predictive clustering trees, will be used to correlate multiple independent variables (e.g., potential biomarkers) to the multiple clinical outcomes (indices of cardio-vascular dysfunction measured by echocardiography).
Measured: During pregnancy, at the time of HDP diagnosis
Number of biomarkers predicting cardiomyocyte hypertrophy and fibroblast proliferation
By exploiting the availability of a library of viral vectors encoding for the whole secretome (about 1200 secreted proteins) and the whole miRNAome (about 2000 human microRNAs) a high throughput screening will be carried out to identify molecules able to control the viability, proliferation and cell size of both primary cardiomyocytes and cardiac fibroblasts. Data mining methods for multi-target prediction, such as ensembles of predictive clustering trees, will be used to correlate multiple independent variables (e.g., potential biomarkers) to the multiple clinical outcomes (indices of cardio-vascular dysfunction measured by echocardiography).
Measured: 24 months post-partum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2023
- Study start15 Oct 2023 (estimated)
- Primary completion15 Mar 2025 (estimated)
- Study completion15 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Burlo Garofolo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tamara Stampalija, MD, Study director, IRCCS materno infantile Burlo Garofolo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05806372
- Sponsor's protocol ID
- RC 29/22
- Status last verified
- Aug 2023
- First submitted
- 28 Mar 2023
- Last updated
- 24 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers of Maternal Cardio-vascular Dysfunction in Pregnancies Complicated by Hypertensive Disorders of Pregnancy
- ClinicalTrials.gov ID
- NCT05806372
- Acronym / sponsor ID
- RC 29/22
- Conditions
- Cardiovascular Diseases, Pregnancy
- Keywords
- Cardiomyocytes, microRNA,, hypertensive disorders of pregnancy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- IRCCS Burlo GarofoloUniversity, hospital or other
- Study start
- 15 Oct 2023 (estimated)
- Primary completion
- 15 Mar 2025 (estimated)
- Study completion
- 15 Mar 2025 (estimated)
- First posted
- 10 Apr 2023 (actual)
- 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.
Profound and concomitant cardiovascular hemodynamic changes, necessary to support fetoplacental development and its increasing supply demands, occur during a physiological pregnancy characterized by an increase in cardiac output, heart rate and plasma volume, and fall in vascular resistance and blood pressure. The result of these changes is a volume overload that will lead to a compensatory transient left ventricular eccentric hypertrophy. This, together with the pro-inflammatory state typical of pregnancy, represents the pregnancy as a stress-test for the maternal cardiovascular system. Pregnancies complicated by hypertensive disorders of pregnancy (HDP), particularly those with early onset and/or complicated by intrauterine fetal growth restriction (FGR), are characterized by a cardiovascular maladaptation. Women who experienced HDP in pregnancy, especially pre-eclampsia (PE), more often develop later in life ischemic heart disease, hypertension and stroke, obesity, dyslipidemia, and end-stage renal disease.
Regardless its clinical impact, very little knowledge is available on the mechanisms by which PE could lead to cardiovascular disease (CVD), and, especially, to heart failure after pregnancy. Preliminary results suggest a cross-talk between pregnancy-induced biomarkers and cardio-vascular system. Particularly, cultures of neonatal rat cardiomyocytes and fibroblasts were used to investigate the role of the serum of women with HDP in regulating their proliferation. 5-ethynyl-2'-deoxyuridine (EdU) was administered to label DNA synthesis in proliferating cells. After 3 days of in vitro culture, EdU incorporation was analyzed upon immunofluorescence staining using specific antibodies by high content microscopy. A possible protective effect exerted by the selected sera against apoptosis was evaluated, as well, by Caspase activation. Moreover, the effect of cardiomyocytes and fibroblasts proliferation and apoptosis on maternal hemodynamic parameters was evaluated using median regression models. These data show that the serum of women with HDP triggers a net increase in the percentage of proliferating cardiomyocytes compared to controls. Moreover, there were relationship between cardiomyocytes and fibroblasts proliferation and maternal hemodynamics parameters thus, supporting the hypothesis that the serum of women with HDP may contain factors capable of stimulating cardiac cells in response to the cardiovascular stress-test
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HDP with FGR | – | –Evaluation of sera and ultrasound data on fetal growth and Doppler velocimetry in women with HDP and fetal growth restriction. |
| HDP without FGR | – | –Evaluation of sera and ultrasound data on fetal growth and Doppler velocimetry in women with HDP and without fetal growth restriction. |
| Normotensive | – | –Evaluation of sera and ultrasound data on fetal growth and Doppler velocimetry in normotensive women. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Singleton pregnant women between 24 and 40 gestational weeks with HDP (with and without fetal growth disorder) and normotensive (controls)
Key inclusion criteria (7 listed)
- Pregnant women affected by HDP
- Women ≥18 years old
- Women able to give an informed consent
- CONTROLS
- Uneventful pregnancy of women ≥18 years old
Key exclusion criteria (4 listed)
- No informed consent
- Women <18 years old
- Presence of other maternal pathologies as viral disease, diabetes
- Fetal chromosomal/structural anomalies
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
Number of biomarkers predicting cardiomyocyte hypertrophy and fibroblast proliferation
Time frame: During pregnancy, at the time of HDP diagnosis
By exploiting the availability of a library of viral vectors encoding for the whole secretome (about 1200 secreted proteins) and the whole miRNAome (about 2000 human microRNAs) a high throughput screening will be carried out to identify molecules able to control the viability, proliferation and cell size of both primary cardiomyocytes and cardiac fibroblasts. Data mining methods for multi-target prediction, such as ensembles of predictive clustering trees, will be used to correlate multiple independent variables (e.g., potential biomarkers) to the multiple clinical outcomes (indices of cardio-vascular dysfunction measured by echocardiography).
Number of biomarkers predicting cardiomyocyte hypertrophy and fibroblast proliferation
Time frame: 24 months post-partum
By exploiting the availability of a library of viral vectors encoding for the whole secretome (about 1200 secreted proteins) and the whole miRNAome (about 2000 human microRNAs) a high throughput screening will be carried out to identify molecules able to control the viability, proliferation and cell size of both primary cardiomyocytes and cardiac fibroblasts. Data mining methods for multi-target prediction, such as ensembles of predictive clustering trees, will be used to correlate multiple independent variables (e.g., potential biomarkers) to the multiple clinical outcomes (indices of cardio-vascular dysfunction measured by echocardiography).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Cardiovascular Diseases
Active, not recruitingPhase 3
ENDOTHELION Study Group: Effect of Bosentan in NAION Patients
Ischemic Optic Neuropathy
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
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.
Tamara Stampalija, MD study director
IRCCS materno infantile Burlo Garofolo
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 Cardiovascular Diseases and Pregnancy, run by IRCCS Burlo Garofolo at 1 site in Italy.
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 7 inclusion and 4 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 24 Aug 2023. 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 Italy. 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?
Contact Tamara Stampalija, MD (+390403785486, tamara.stampalija@burlo.trieste.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of biomarkers predicting cardiomyocyte hypertrophy and fibroblast proliferation (time frame: During pregnancy, at the time of HDP diagnosis). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Aug 2023.