Actively Recruiting
Association of Heterogeneous Circulating Biomarkers and Anamnestic Factors of Pregnancy Adverse Course and Outcomes With the Prognosis of Heart Failure With Preserved Ejection Fraction
Led by National Medical Research Center for Therapy and Preventive Medicine · Updated on 2025-01-31
100
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying women aged 60 to 74 years who have heart failure with preserved ejection fraction (HFpEF) and a history of pregnancy lasting at least 20 weeks. The study aims to investigate how various circulating biomarkers and pregnancy-related factors like gestational hypertension, preeclampsia, gestational diabetes, preterm delivery, stillbirth, and miscarriage relate to the prognosis of HFpEF. These pregnancy factors are considered as potential risks for cardiovascular disease. Participants undergo an initial visit where they complete a questionnaire about pregnancy complications, menopause, and medical history. Medical records provide additional data on comorbidities and test results. Physical exams measure body data and signs of heart congestion, and surveys assess breath shortness severity. Blood samples are collected to measure specific biomarkers linked to heart failure, such as high-sensitivity troponin I and cystatin C. Echocardiography is performed to evaluate heart muscle function. Twelve months after the first visit, researchers follow up by phone to collect information about new chronic diseases, emergency hospitalizations, major heart-related events, or death. If participants cannot be reached, trusted contacts are called to determine their status. The main outcome measured is a combined endpoint of emergency hospital admission, major cardiovascular events, or death within one year. This observational study tracks health status and heart failure progression over time.
CONDITIONS
Brief 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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 60-74 years
- Diagnosed heart failure with preserved ejection fraction using the HFA-PEFF algorithm
- History of pregnancy lasting at least 20 weeks
- Willing and legally able to sign informed consent
You will not qualify if you...
- History of ejection fraction less than 50% diagnosed by echocardiography
- Diagnosed cognitive impairment or dementia
- Current state of cardiovascular disease decompensation
- Exacerbation of comorbidities
- Presence of chronic diseases affecting study results, including unstable angina, severe effort angina (grade III-IV), previous myocardial infarction, previous ischemic or hemorrhagic stroke, severe valvular heart diseases, cardiomyopathy, myocarditis, uncontrolled bronchial asthma or chronic obstructive pulmonary disease
- Terminal chronic kidney disease requiring dialysis
- Implanted pacemaker, cardiac resynchronisation device, or defibrillator
- Active cancer or history of chemotherapy or radiation therapy to the chest area
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 year
Participants are observed to assess the prognosis of heart failure with preserved ejection fraction and related health outcomes.
Periodic visits as per study schedule
Trial Site Locations
Total: 1 location
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, 101990
Actively Recruiting
Research Team
V
Vasilisa Kosulina, MD
O
Olga Dzhioeva, MD, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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