Phenotypes and Outcomes of Heart Failure With Preserved Ejection Fraction in Patients With Hypertension and Diabetes

University of Medicine and Pharmacy at Ho Chi Minh City233 enrolled

Overview

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 (HTN). The purpose of this study is to identify different phenotypes of the Vietnamese HFpEF-HTN-T2DM population, as well as the association of these phenotypes with long-term outcomes.

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 grouped into phenotypes. During the 12 month follow up, investigators will collect information on predefined outcomes, especially the all cause mortality and hospitalization for heart failure, thereby establishing the association between phenotypes and outcomes. The knowledge gained from the study is supposed to add valuable information on the feasibility of phenotype-guided approach for heart failure with preserved ejection fraction in patients with hypertension and diabetes.

Study Type

OBSERVATIONAL

Enrollment

233

Conditions

Heart Failure With Preserved Ejection Fraction Diabetes Mellitus, Type 2 Hypertension

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Criteria: * 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

Outcomes

Primary Outcomes

Phenotypes of heart failure with preserved ejection fraction in patients with concurrent hypertension and diabetes.

Time frame: At baseline

Composite primary endpoint

Composite primary endpoint: Time to first event of composite outcome (all-cause mortality, or hospitalization for heart failure (HHF)) in patients with heart failure with preserved ejection fraction and concurrent hypertension, diabetes.

Time frame: 12 months - Up to 18 months from baseline

Combined endpoint

Combined endpoint: Time to first event of composite outcome (Cardiovascular mortality, or hospitalization for heart failure (HHF)) in patients with heart failure with preserved ejection fraction and concurrent hypertension, diabetes.

Time frame: 12 months - Up to 18 months from baseline

The correlation between clinical phenotypes and composite primary endpoint

The correlation between clinical phenotypes and composite primary endpoint: Time to first event of all-cause mortality, hospitalization for heart failure (HHF) in patients with heart failure with preserved ejection fraction and concurrent hypertension, diabetes.