Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06338943
Status:
RECRUITING
Last Update Posted:
2024-04-01
First Post:
2024-03-24
Brief Title:
Middle-aged Women With Adverse Pregnancy Outcomes and Heart Failure With Preserved Ejection Fraction
Sponsor:
National Medical Research Center for Therapy and Preventive Medicine
Organization:
National Medical Research Center for Therapy and Preventive Medicine
Study Overview
Official Title:
Middle-aged Women With Adverse Pregnancy Outcomes and Heart Failure With Preserved Ejection Fraction
Status:
RECRUITING
Status Verified Date:
2024-03
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:
MAPO-HF
Brief 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 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
1 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
2 To compare clinical and anamnestic data morphological and functional parameters of the heart in middle-aged women with the presence and absence of HFpEF
3 To establish an association between APOs and the development of HFpEF in the long-term period in middle-aged women
4 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
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
1 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
2 To compare clinical and anamnestic data morphological and functional parameters of the heart in middle-aged women with the presence and absence of HFpEF
3 To establish an association between APOs and the development of HFpEF in the long-term period in middle-aged women
4 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 womans 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 womans future
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 womans 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 womans future
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None