Heart Failure Preserved Ejection FractionMAPO-HFNCT06338943
Middle-aged Women With Adverse Pregnancy Outcomes and Heart Failure With Preserved Ejection Fraction
An observational study of Heart Failure Preserved Ejection Fraction and Pregnancy Complications, run by National Medical Research Center for Therapy and Preventive Medicine at 1 site in Russia.
Trial summary
Due to the steady increase in the burden of HFpEF, especially in women, it is an important task to search for new markers and early predictors associated with the development of this disease. Read more about this study
- Who is it for?
- Ages 45 to 60 years, women only
- Conditions the study is for
- Heart Failure Preserved Ejection Fraction, Pregnancy Complications
- What is being tested?
- Echocardiography and Questionnaire
- How many people
- 100 participants
- Where
- 1 siteRussia
- Study dates
- 18 Mar 2024to Jan 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 45 to 60 years
- Women only
- No healthy volunteers
- Adult
Study population: Generic Moscow population
Who may be able to join
- All patients who administer to the Federal State Budgetary Institution National Medical Research Center for Therapy and Preventive Medicine, who are undergoing echocardiography for medical reasons
- Pregnancy >20 weeks in the anamnesis
- Signed informed consent to participate in the study
Who cannot join
- Refusal to sign an informed consent to participate in a clinical trial and to process personal data
- Detection of left ventricle ejection fraction < 50% according to Echocardiography data
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
National Medical Research Center for Therapy and Preventive Medicine
Moscow
Olga Dzhioeva, MD, PhD, +79166141821, odzhioeva@gnicpm.ru
Max Shperling, MD
About this study
Due to the steady increase in the burden of HFpEF, especially in women, it is an important task to search for new markers and early predictors associated with the development of this disease. Nowadays, the relationship of adverse pregnancy factors with the development of long-term cardiac pathology, in particular, HFpEF, has not been completely established. One of the most significant issue is studying the younger phenotype of women.
The goal of this observational analytical cross-sectional study is to study the relationship of heart failure with a preserved ejection fraction in middle-aged women with adverse pregnancy outcomes in the history of pregnancy.
Read more
Research question: is there an association between adverse pregnancy factors and the development of HF in middle-aged women?
Objectives
- To assess the frequency of detection of APOs in the history of pregnancy in middle-aged women, depending on the presence or absence of HFpEF.
- To compare clinical and anamnestic data, morphological and functional parameters of the heart in middle-aged women with the presence and absence of HFpEF.
- To establish an association between APOs and the development of HFpEF in the long-term period in middle-aged women.
- To identify mediators between the presence of APOs and the development of HFpEF in middle-aged women.
Study population - 45-60 year-old women with the history of pregnancy (>20 weeks) in the absence of low left ventricle ejection fraction (<50%)
Primary endpoint: The prevalence of HFpEF in patients with the history of APOs.
Read the detailed description
Heart failure (HF) occupies a special place in the structure of cardiological pathology. This is largely due to the active modernization of approaches to the diagnosis of HF - every year the possibilities of cardiac imaging increase significantly, which leads to dynamic changes in the criteria for diagnosis. To the greatest extent, these changes affect heart failure with a preserved ejection fraction (HFpEF; left ventricular ejection fraction ≥ 50%), the importance of which is steadily growing with increasing life expectancy, obesity and cardiometabolic disorders. If in the recent past, HF was perceived not as independent disease, which is a complication of the underlying cardiac pathology, today, due to the increasing detectability of HFpEF, the latter can be considered as a separate multifactorial disease. Patients with HFpEF make up about half of the population of patients with HF, which, together with difficulties in understanding the pathophysiological mechanisms of the disease, is a significant problem for clinical practice.
Due to the steady increase in the burden of HFpEF, especially in women, it is an important task to search for new markers and early predictors associated with the development of this disease. This area of scientific activity has become especially popular in recent years in both world and domestic cardiology. The leading causes of the development of HFpEF are old age, obesity, coronary heart disease and pulmonary hypertension. A significant association has also been established with such markers as female gender, diabetes mellitus (DM), chronic kidney disease (CKD), alcohol abuse, arterial hypertension, smoking and others. Important issue now is the study of the association of pregnancy factors and its complications with the development of various forms of HF in both early and long-term periods. It is known that significant changes in a woman's body during pregnancy contribute to the development of important structural and hemodynamic changes in the cardiovascular system, which, in the absence of predisposing adverse factors, are in most cases reversible. Unfortunately, pathology detected during pregnancy is also often a trigger factor for the formation of structural remodeling of the heart and blood vessels, which can lead to the development of HF in the long term after pregnancy.
Despite the presence of large foreign studies reflecting the high incidence of various forms of chronic non-communicable diseases in women with adverse in the gestational period, the relationship of adverse pregnancy outcomes (APOs) with the development of long-term cardiac pathology, in particular, HFpEF, has not been sufficiently studied. Moreover, approaches to the diagnosis of HFpEF vary significantly, there are often no diagnostic protocols in the studies. In such works, a universal approach is more frequently used without dividing patients into phenotypes, depending on age and comorbidity ("one-size-fits-all approach"), which is critically important in assessing such a heterogeneous disease. The above factors make the interpretation of the data and conclusions ambiguous.
To date, the issue of the association of adverse pregnancy factors with the development of HFpEF in the long-term period is unsolved. It is particularly interesting to study the younger phenotype of patients due to the greater detectability of HFpEF in this group of individuals in Russia compared with Western countries. Studying the nature of this relationship will expand understanding of the role of different APOs in the development of structural and functional changes of the heart in a woman's future.
- Being tested
- Echocardiography, Questionnaire
- Keywords
- Heart Failure Preserved Ejection Fraction, Adverse Pregnancy Outcomes, Arterial Hypertension, Gestational Diabetes, Mediation
- Medical subject headings
- Heart Failure, Diastolic, Pregnancy Complications, Hypertension, Diabetes, Gestational, Negotiating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchocardiographyDiagnostic test
Echocardiography to diagnose HFpEF
QuestionnaireOther
Questionnaire to determine the presence of adverse pregnancy outcomes history
| Study group | Role | What they receive |
|---|---|---|
| Patient with the history of pregnancy | Patient with the history of pregnancy (1 or more > 20 weeks)
This group will further be subdivided in a subgroup with HFpEF and a group without HFpEF Receives: Diagnostic Test: Echocardiography; Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
HFpEF incidence
Heart Failure with Preserved Ejection Fraction will be assessed with the transthoracic echocardiography based on the criteria of American Heart Association guidelines, where left ventricle ejection fraction > 50%.
Measured: on enrollment
APOs incidence
Adverse pregnancy outcomes will be determined by means of questionnaire
Measured: on enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2024
- Study start18 Mar 2024
- Primary completionJan 2025 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure Preserved Ejection FractionStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Medical Research Center for Therapy and Preventive Medicine
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Olga Dzhioeva, MD, PhD, Study director, National Medical Research Center for Therapy and Preventive Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06338943
- Sponsor's protocol ID
- 02-02/24
- Acronym
- MAPO-HF
- Status last verified
- Mar 2024
- First submitted
- 24 Mar 2024
- Last updated
- 1 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Middle-aged Women With Adverse Pregnancy Outcomes and Heart Failure With Preserved Ejection Fraction
- ClinicalTrials.gov ID
- NCT06338943
- Acronym / sponsor ID
- MAPO-HF / 02-02/24
- Keywords
- Heart Failure Preserved Ejection Fraction, Adverse Pregnancy Outcomes, Arterial Hypertension, Gestational Diabetes, Mediation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Medical Research Center for Therapy and Preventive MedicineOther government
- Study start
- 18 Mar 2024 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 1 Apr 2024 (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.
Due to the steady increase in the burden of HFpEF, especially in women, it is an important task to search for new markers and early predictors associated with the development of this disease. Nowadays, the relationship of adverse pregnancy factors with the development of long-term cardiac pathology, in particular, HFpEF, has not been completely established. One of the most significant issue is studying the younger phenotype of women.
The goal of this observational analytical cross-sectional study is to study the relationship of heart failure with a preserved ejection fraction in middle-aged women with adverse pregnancy outcomes in the history of pregnancy.
Research question: is there an association between adverse pregnancy factors and the development of HF in middle-aged women?
Objectives
- To assess the frequency of detection of APOs in the history of pregnancy in middle-aged women, depending on the presence or absence of HFpEF.
- To compare clinical and anamnestic data, morphological and functional parameters of the heart in middle-aged women with the presence and absence of HFpEF.
- To establish an association between APOs and the development of HFpEF in the long-term period in middle-aged women.
- To identify mediators between the presence of APOs and the development of HFpEF in middle-aged women.
Study population - 45-60 year-old women with the history of pregnancy (>20 weeks) in the absence of low left ventricle ejection fraction (<50%)
Primary endpoint: The prevalence of HFpEF in patients with the history of APOs.
Detailed description
Heart failure (HF) occupies a special place in the structure of cardiological pathology. This is largely due to the active modernization of approaches to the diagnosis of HF - every year the possibilities of cardiac imaging increase significantly, which leads to dynamic changes in the criteria for diagnosis. To the greatest extent, these changes affect heart failure with a preserved ejection fraction (HFpEF; left ventricular ejection fraction ≥ 50%), the importance of which is steadily growing with increasing life expectancy, obesity and cardiometabolic disorders. If in the recent past, HF was perceived not as independent disease, which is a complication of the underlying cardiac pathology, today, due to the increasing detectability of HFpEF, the latter can be considered as a separate multifactorial disease. Patients with HFpEF make up about half of the population of patients with HF, which, together with difficulties in understanding the pathophysiological mechanisms of the disease, is a significant problem for clinical practice.
Due to the steady increase in the burden of HFpEF, especially in women, it is an important task to search for new markers and early predictors associated with the development of this disease. This area of scientific activity has become especially popular in recent years in both world and domestic cardiology. The leading causes of the development of HFpEF are old age, obesity, coronary heart disease and pulmonary hypertension. A significant association has also been established with such markers as female gender, diabetes mellitus (DM), chronic kidney disease (CKD), alcohol abuse, arterial hypertension, smoking and others. Important issue now is the study of the association of pregnancy factors and its complications with the development of various forms of HF in both early and long-term periods. It is known that significant changes in a woman's body during pregnancy contribute to the development of important structural and hemodynamic changes in the cardiovascular system, which, in the absence of predisposing adverse factors, are in most cases reversible. Unfortunately, pathology detected during pregnancy is also often a trigger factor for the formation of structural remodeling of the heart and blood vessels, which can lead to the development of HF in the long term after pregnancy.
Despite the presence of large foreign studies reflecting the high incidence of various forms of chronic non-communicable diseases in women with adverse in the gestational period, the relationship of adverse pregnancy outcomes (APOs) with the development of long-term cardiac pathology, in particular, HFpEF, has not been sufficiently studied. Moreover, approaches to the diagnosis of HFpEF vary significantly, there are often no diagnostic protocols in the studies. In such works, a universal approach is more frequently used without dividing patients into phenotypes, depending on age and comorbidity ("one-size-fits-all approach"), which is critically important in assessing such a heterogeneous disease. The above factors make the interpretation of the data and conclusions ambiguous.
To date, the issue of the association of adverse pregnancy factors with the development of HFpEF in the long-term period is unsolved. It is particularly interesting to study the younger phenotype of patients due to the greater detectability of HFpEF in this group of individuals in Russia compared with Western countries. Studying the nature of this relationship will expand understanding of the role of different APOs in the development of structural and functional changes of the heart in a woman's future.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with the history of pregnancy | – | Diagnostic Test: Echocardiography, Other: QuestionnairePatient with the history of pregnancy (1 or more > 20 weeks) This group will further be subdivided in a subgroup with HFpEF and a group without HFpEF |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Generic Moscow population
Key inclusion criteria (3 listed)
- All patients who administer to the Federal State Budgetary Institution National Medical Research Center for Therapy and Preventive Medicine, who are undergoing echocardiography for medical reasons
- Pregnancy >20 weeks in the anamnesis
- Signed informed consent to participate in the study
Key exclusion criteria (2 listed)
- Refusal to sign an informed consent to participate in a clinical trial and to process personal data
- Detection of left ventricle ejection fraction < 50% according to Echocardiography data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EchocardiographyEchocardiography to diagnose HFpEF | Diagnostic test | Patient with the history of pregnancy |
| QuestionnaireQuestionnaire to determine the presence of adverse pregnancy outcomes history | Other | Patient with the history of pregnancy |
Primary outcome
HFpEF incidence
Time frame: on enrollment
Heart Failure with Preserved Ejection Fraction will be assessed with the transthoracic echocardiography based on the criteria of American Heart Association guidelines, where left ventricle ejection fraction > 50%.
APOs incidence
Time frame: on enrollment
Adverse pregnancy outcomes will be determined by means of questionnaire
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2024.
- Individual participant dataSharing planned: No
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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.
Olga Dzhioeva, MD, PhD study director
National Medical Research Center for Therapy and Preventive Medicine
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 Preserved Ejection Fraction and Pregnancy Complications, run by National Medical Research Center for Therapy and Preventive Medicine at 1 site in Russia.
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 3 inclusion and 2 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 1 Apr 2024. 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 Russia. 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 Max Shperling, MD (+79118170034, MaxCardio@yandex.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HFpEF incidence (time frame: on enrollment). 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 1 Apr 2024.