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

NCT06803849 | Recruiting DMC

• 1 other identifier: 04-07/24
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Heart Failure With Preserved Ejection Fraction (HFPEF)

Keywords

Heart Failure with Preserved Ejection Fraction; Adverse Pregnancy Outcomes; Gestational Hypertension; Preeclampsia; Gestational Diabetes Mellitus; Heart Diseases; Cardiovascular Diseases; Heart Failure; Pregnancy Complications; Preterm delivery; Stillbirth

Outcome Measures

Primary Outcomes (1)

• Combined endpoint made up of emergency hospitalization for any cause, major adverse cardiovascular events and all-cause mortality

  Major adverse cardiovascular events include myocardial infarction, stroke, cardiovascular death

  From the date of enrollment until the date of the first emergency hospitalization for any cause or date of any major adverse cardiovascular event or all-cause death, whichever came first, assessed up to 1 years

Secondary Outcomes (1)

• Newly diagnosed chronic non-communicable disease

  From the date of enrollment until the date of diagnosis of any chronic non-communicable disease, whichever came first, assessed up to 1 years

Study Arms (2)

Patients with anamnestic factors of pregnancy adverse course and outcomes

Patients without anamnestic factors of pregnancy adverse course and outcomes

Eligibility Criteria

• Age: 60 Years - 74 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• History of ejection fraction less than 50% diagnosed by echocardiography
• Diagnosed cognitive impairment or dementia
• The state of cardiovascular disease decompensation
• Exacerbation of comorbidities
• 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

Sponsors & Collaborators

• National Medical Research Center for Therapy and Preventive Medicine: lead

Study Sites (1)

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

Moscow, 101990, Russia

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Venous blood

MeSH Terms

Conditions

Hypertension, Pregnancy-Induced; Pre-Eclampsia; Diabetes, Gestational; Heart Diseases; Cardiovascular Diseases; Heart Failure; Pregnancy Complications; Premature Birth; Stillbirth

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension; Vascular Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Obstetric Labor, Premature; Obstetric Labor Complications; Fetal Death; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Vasilisa Kosulina, MD

CONTACT

+7-996-981-40-27; vasilisa.kosulina@mail.ru

Olga Dzhioeva, MD, PhD

CONTACT

+7-916-614-18-21; odzhioeva@gnicpm.ru

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2025
• First Posted: January 31, 2025
• Study Start: November 15, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 31, 2025

Record last verified: 2025-01

Locations

RU (1)