Blood markers and pregnancy history in women with heart failure
Studies blood markers and pregnancy history in women aged 60 to 74 with heart failure.
Plain-language title generated from the registry record
Registry title: Association of Heterogeneous Circulating Biomarkers and Anamnestic Factors of Pregnancy Adverse Course and Outcomes With the Prognosis of Heart Failure With Preserved Ejection Fraction
Key facts
- Where
- Moscow, RussiaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 60 and 74 years old?
Source: NCT06803849, who can take part
Where in Russia
- Federal State Budgetary Institution National Medical Research Center for Therapy and Preventive Medicine of the Ministry of Healthсare of the Russian FederationMoscow, RussiaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- National Medical Research Center for Therapy and Preventive Medicine
- Trial code
- NCT06803849
- Record updated
- 31 January 2025
- Original description
The primary purpose of this study is to evaluate possible association of some heterogeneous circulating biomarkers and anamnestic factors of pregnancy adverse course and outcomes with the prognosis of heart failure with preserved ejection fraction. The study population includes women aged 60-74 years with history of pregnancy with duration at least 20 weeks and diagnosed heart failure with preserved ejection fraction based on algorithm HFA-PEFF.Read full original descriptionShow less
Association of Heterogeneous Circulating Biomarkers and Anamnestic Factors of Pregnancy Adverse Course and Outcomes With the Prognosis of Heart Failure With Preserved Ejection Fraction
The primary purpose of this study is to evaluate possible association of some heterogeneous circulating biomarkers and anamnestic factors of pregnancy adverse course and outcomes with the prognosis of heart failure with preserved ejection fraction. The study population includes women aged 60-74 years with history of pregnancy with duration at least 20 weeks and diagnosed heart failure with preserved ejection fraction based on algorithm HFA-PEFF.
The following pregnancy complications are assessed on the initial visit: gestational hypertension, preeclampsia, gestation diabetes mellitus and recently introduced as cardiovascular disease risk factors preterm delivery, stillbirth, miscarriage. This information is collected through a questionnaire which additionally includes questions about menopause and the circumstances of its onset. The data about comorbidities, results of laboratory and instrumental tests is collected from medical records. After the interview short physical examination is performed to measure anthropometric data and objective signs of congestion. In addition, medical Research Council Scale survey is conducted to assess the subjective severity of shortness of breath and a six-minute walking test to objectively evaluate the heart failure functional class.
After inclusion in the study blood sampling is performed to measure the concentration of a number of biomarkers which are recognized as prognostically significant in context of heart failure: high-sensitivity troponin I, soluble suppression of tumorigenicity 2 protein, heat shock protein 27, cystatin C. As part of the study echocardiography is also performed with evaluation of left ventricular global longitudinal strain and left atrial strain to assess systolic and diastolic myocardium function.
12 months after the initial visit, participants are contacted by telephone. The data about newly diagnosed chronic non-communicable diseases, emergency hospitalization for any cause and major adverse cardiovascular events is collected. If there is no response from the research participant, the cause, including possible hospitalization or death, is determined by telephone contact with the participant's trusted person.
Inclusion: Women aged 60-74 years; Heart failure with preserved ejection fraction (diagnosed by using HFA-PEFF algorithm); History of pregnancy with duration at least 20 weeks; Willing and legally able to sign informed consent.
Exclusion: The presence of chronic diseases that may affect the results of the study: ischemic heart disease (unstable angina, stable effort angina III-IV grade, previous myocardial infarction), previous Ischemic/hemorrhagic stroke, severe valvular heart diseases, cardiomyopathy, myocarditis, uncontrolled bronchial asthma or chronic obstructive pulmonary disease, terminal chronic kidney disease requiring dialysis, implanted pacemaker (including cardiac resynchronisation device, or defibrillator), active cancer, history of chemotherapy or radiation therapy to the chest area; Diagnosed cognitive impairment or dementia; The state of cardiovascular disease decompensation; History of ejection fraction less than 50% diagnosed by echocardiography; Exacerbation of comorbidities.