Status:
COMPLETED
Phenotypes and Outcomes of Heart Failure With Preserved Ejection Fraction in Patients With Hypertension and Diabetes
Lead Sponsor:
University of Medicine and Pharmacy at Ho Chi Minh City
Conditions:
Heart Failure With Preserved Ejection Fraction
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18+ years
Brief Summary
Our study is the first multicenter study in Vietnam on clinical phenotypes of heart failure with preserved ejection fraction (HFpEF) in patients with concurrent type 2 diabetes (T2DM) and hypertension...
Detailed Description
The study is expected to provide further understanding on the characteristics, risk profiles and treatment patterns of an emergingly common and high-risk population. At baseline, patients will be grou...
Eligibility Criteria
Inclusion
- Male or female, at least 18 years at screening
- Preexisting or newly diagnosed hypertension, diabetes
- Preexisting or newly diagnosed heart failure with preserved ejection fraction using 2016 European Society of Cardiology's guideline on heart failure.
- Signs and symptoms of heart failure
- N-terminal pro brain natriuretic peptide (NT-proBNP) ≥300 in acute setting, and ≥125 in chronic setting
- Echocardiography with left ventricular ejection fraction (LVEF) ≥50% and at least one of these following criteria:
- Structural changes indicated by either left ventricle (LV) hypertrophy (any of the following: intraventricular septal or posterior wall thickness ≥1.1 cm, and/or LV mass index ≥115 g/m\*2 in male and ≥95 g/m\*2 in female), or left atrium (LA) enlargement (any of the following: left atrial volume (LAV) index ≥34 ml/m\*2, or or LA diameter \>40 mm)
- Further inclusion criteria apply
Exclusion
- Listed for heart transplant
- Primary stage D valvular heart disease requiring surgery or intervention, prosthetic or mechanical valve.
- Severe, unrepaired pericardiac disease
- Complex, unrepaired congenital heart disease
- Takotsubo disease, peripartum cardiomyopathy, chemotherapy-induced cardiomyopathy, cardiac sarcoidosis/amyloidosis.
- End stage renal dysfunction, defined as persistent estimated glomerular filtration rate (eGFR)\<15 ml/min (CKD-EPI Chronic Kidney Disease Epidemiology Collaboration Equation) or requiring renal replacement therapy.
- Child-Pugh-Turcotte C.
- Life expectancy \<1 year due to non-cardiac etiology, as per investigator judgement
- Severe pulmonary disease requiring continuous home oxygen
- Pregnancy or lactation.
- Concurrent enrolment in another interventional device or drug trial
- Further exclusion criteria may apply
Key Trial Info
Start Date :
December 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 28 2023
Estimated Enrollment :
233 Patients enrolled
Trial Details
Trial ID
NCT04835194
Start Date
December 1 2020
End Date
February 28 2023
Last Update
March 2 2023
Active Locations (2)
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1
Nhan Dan Gia Dinh Hospital
Ho Chi Minh City, Ho Chi Minh, Vietnam, 700 000
2
University Medical Center
Ho Chi Minh City, Vietnam, 700000