RecruitingNCT06803849

Association of Heterogeneous Circulating Biomarkers and Anamnestic Factors of Pregnancy Adverse Course and Outcomes With the Prognosis of Heart Failure With Preserved Ejection Fraction


Sponsor

National Medical Research Center for Therapy and Preventive Medicine

Enrollment

100 participants

Start Date

Nov 15, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Sex: FEMALEMin Age: 60 YearsMax Age: 74 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at whether certain blood markers and pregnancy history can help predict how well women with a specific type of heart failure (where the heart pumps normally but is too stiff) will do over time. **You may be eligible if...** - You are a woman between 60 and 74 years old - You have been diagnosed with heart failure with preserved ejection fraction (a type of heart failure where the pumping function is normal but the heart muscle is stiff) - You have a history of at least one pregnancy lasting 20 or more weeks - You are willing and able to sign an informed consent form **You may NOT be eligible if...** - You have had a heart that pumps weakly (ejection fraction below 50%) on an ultrasound - You have been diagnosed with memory loss or dementia - Your heart failure or other medical conditions are currently unstable or getting worse - You have serious conditions like a previous heart attack, stroke, severe valve disease, uncontrolled asthma, kidney failure requiring dialysis, a pacemaker, or active cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

Federal State Budgetary Institution National Medical Research Center for Therapy and Preventive Medicine of the Ministry of Healthсare of the Russian Federation

Moscow, Russia

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NCT06803849


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