Status:
COMPLETED
Neuregulin-1 in Patient With Different Forms of Cardiovascular Diseases: a Pilot Study
Lead Sponsor:
I.M. Sechenov First Moscow State Medical University
Collaborating Sponsors:
Universiteit Antwerpen
University of Basel
Conditions:
Heart Failure With Preserved Ejection Fraction
Microvascular Angina
Eligibility:
All Genders
18-75 years
Brief Summary
This is an observational study of Neuregulin-1 (NRG-1) plasma levels in patients with different forms of cardiovascular disease including microvascular angina (MVA), heart failure with preserved eject...
Detailed Description
NRG-1 is a paracrine growth factor with physiological actions in the cardiovascular system which is primarily expressed by the endothelium of coronary microvessels. NRG-1 is a natural paracrine agonis...
Eligibility Criteria
Inclusion
- Able to provide informed consent
- Confirmed diagnosis of HFpEF (Symptoms of HF (NYHA II-IV); LVEF \>50%; Elevated levels of natriuretic peptides (NT-pro BNP \> 300 pg/ml in sinus rhythm, \>600 pg/ml in AF);Relevant structural heart disease (Left ventricle hypertrophy (LVH) and/or Left atrium enlargement (LAE); left atrial volume index (LAVI) \>34 mL/m2 or a left ventricular mass index (LVMI) =115 g/m2 for males and =95 g/m2 for females)
- Confirmed diagnosis of MVA (Angina-like chest pain: signs of exercise-induced ischemia (ST-depression on exercise ECG (\>1 mm down-sloping or rectilinear ST-segment depression in \>2 leads)); No fixed stenosis (\>50%) in epicardial coronary arteries or branches at baseline coronary arteriography)
- Confirmed diagnosis of PH (PH due to left heart disease (Left ventricular systolic dysfunction, Left ventricular diastolic dysfunction, Valvular disease, Congenital/acquired left heart inflow/outflow obstruction and congenital cardiomyopathies); Chronic thromboembolic pulmonary hypertension; Peak tricuspid regurgitation velocity =2.8 m/s and presence of other echo 'PH signs')
- Confirmed diagnosis of HFrEF (Symptomatic HF (NYHA class II-IV), left ventricular ejection fraction ≤ 35% (at any time in the past))
Exclusion
- Patients with hypertrophic cardiomyopathy, rheumatic heart disease, constrictive pericarditis, significant valvular pathological change or congenital heart diseases
- Primary pulmonary artery hypertension
- Acute MI in the last 3 months
- Unstable angina
- Chronic heart failure patients with acute decompensation in the last 1 month (symptoms and signs suggest worsening chronic heart failure and may require intravenous drug therapy)
- Cardiac surgery or cerebrovascular accident within the recent six months
- Severe hepatic or renal dysfunction
- Severe nervous system diseases
- History of any malignancy or suffering from cancer
- Lack of informed consent
Key Trial Info
Start Date :
March 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2023
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04391491
Start Date
March 1 2019
End Date
February 1 2023
Last Update
May 3 2023
Active Locations (1)
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1
Anastasia Shchendrygina
Moscow, Russia, 119415