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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Clinical Phenotypes of Heart Failure With Preserved Ejection Fraction and Its Association With Cardiovascular Outcomes in Patients With Hypertension and Diabetes

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

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Phenotype 1 (from LCA)<br> | |
| Phenotype 2 (from LCA)<br> | |
| Phenotype 3 (from LCA)<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phenotypes of heart failure with preserved ejection fraction in patients with concurrent hypertension and diabetes. | Phenotypes of heart failure with preserved ejection fraction in patients with concurrent hypertension and diabetes. | 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. | 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. | 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. | 12 months- Up to 18 months from baseline | 
| The correlation between clinical phenotypes and combined endpoint | The correlation between clinical phenotypes and combined endpoint: Time to first event of CV mortality, hospitalization for heart failure (HHF) in patients with heart failure with preserved ejection fraction and concurrent hypertension, diabetes. | 12 months- Up to 18 months from baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurence of HHF (first and recurrent) in patients with heart failure with preserved ejection fraction and concurrent hypertension, diabetes. | Occurence of HHF (first and recurrent) in patients with heart failure with preserved ejection fraction and concurrent hypertension, diabetes. | 12 months- Up to 18 months from baseline | 
| All cause mortality in patients with heart failure with preserved ejection fraction and concurrent hypertension, diabetes. | All cause mortality in patients with heart failure with preserved ejection fraction and concurrent hypertension, diabetes. | 12 months- Up to 18 months from baseline | 
| Cardiovascular mortality in patients with heart failure with preserved ejection fraction and concurrent hypertension, diabetes. | All cause mortality in patients with heart failure with preserved ejection fraction and concurrent hypertension, diabetes. | 12 months- Up to 18 months from baseline | 
| Time to first occurence of HHF (first and recurrent) in patients with heart failure with preserved ejection fraction and concurrent hypertension, diabetes. | Time to first occurence of HHF (first and recurrent) in patients with heart failure with preserved ejection fraction and concurrent hypertension, diabetes. | 12 months- Up to 18 months from baseline | 
| Time to first all cause mortality in patients with heart failure with preserved ejection fraction and concurrent hypertension, diabetes | Time to first all cause mortality in patients with heart failure with preserved ejection fraction and concurrent hypertension, diabetes | 12 months- Up to 18 months from baseline | 
| Time to first cardiovascular mortality in patients with heart failure with preserved ejection fraction and concurrent hypertension, diabetes. | Time to first cardiovascular mortality in patients with heart failure with preserved ejection fraction and concurrent hypertension, diabetes. | 12 months- Up to 18 months from baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart failure with preserved ejection fraction, Diabetes Mellitus, Type 2, Hypertension