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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04835194
Other study ID # 2129-ÐHYD
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 1, 2020
Est. completion date February 28, 2023

Study information

Verified date February 2023
Source University of Medicine and Pharmacy at Ho Chi Minh City
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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 (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.


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 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.


Recruitment information / eligibility

Status Completed
Enrollment 233
Est. completion date February 28, 2023
Est. primary completion date January 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Vietnam Nhan Dan Gia Dinh Hospital Ho Chi Minh City Ho Chi Minh
Vietnam University Medical Center Ho Chi Minh City

Sponsors (1)

Lead Sponsor Collaborator
University of Medicine and Pharmacy at Ho Chi Minh City

Country where clinical trial is conducted

Vietnam, 

Outcome

Type Measure Description Time frame Safety issue
Other The correlation between clinical phenotypes and time to the first occurence of HHF (first and recurrent) in patients with heart failure with preserved ejection fraction and concurrent hypertension, diabetes. The correlation between clinical phenotypes and time to the 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
Other The correlation between clinical phenotypes and time to all cause mortality in patients with heart failure with preserved ejection fraction and concurrent hypertension, diabetes. The correlation between clinical phenotypes and time to all cause mortality in patients with heart failure with preserved ejection fraction and concurrent hypertension, diabetes. 12 months- Up to 18 months from baseline
Other The correlation between clinical phenotypes and time to cardiovascular mortality in patients with heart failure with preserved ejection fraction and concurrent hypertension, diabetes. The correlation between clinical phenotypes and time to cardiovascular mortality in patients with heart failure with preserved ejection fraction and concurrent hypertension, diabetes. 12 months- Up to 18 months from baseline
Other The correlation between clinical phenotypes and the occurence of HHF (first and recurrent) in patients with heart failure with preserved ejection fraction and concurrent hypertension, diabetes. The correlation between clinical phenotypes and the 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
Other The correlation between clinical phenotypes and all cause mortality in patients with heart failure with preserved ejection fraction and concurrent hypertension, diabetes. The correlation between clinical phenotypes and all cause mortality in patients with heart failure with preserved ejection fraction and concurrent hypertension, diabetes. 12 months- Up to 18 months from baseline
Other The correlation between clinical phenotypes and cardiovascular mortality in patients with heart failure with preserved ejection fraction and concurrent hypertension, diabetes. The correlation between clinical phenotypes and cardiovascular mortality in patients with heart failure with preserved ejection fraction and concurrent hypertension, diabetes. 12 months- Up to 18 months from baseline
Other The correlation between clinical phenotypes and combined endpoint of cardiovascular mortality and cardiovascular hospitalization in patients with heart failure with preserved ejection fraction and concurrent hypertension, diabetes. The correlation between clinical phenotypes and combined endpoint of cardiovascular mortality and cardiovascular hospitalization in patients with heart failure with preserved ejection fraction and concurrent hypertension, diabetes. 12 months- Up to 18 months from baseline
Other The correlation between clinical phenotypes and non-cardiovascular mortality in patients with heart failure with preserved ejection fraction and concurrent hypertension, diabetes. The correlation between clinical phenotypes and non- cardiovascular mortality in patients with heart failure with preserved ejection fraction and concurrent hypertension, diabetes. 12 months- Up to 18 months from baseline
Other The correlation between clinical phenotypes and non-cardiovascular hospitalization in patients with heart failure with preserved ejection fraction and concurrent hypertension, diabetes. The correlation between clinical phenotypes and non- cardiovascular hospitalization in patients with heart failure with preserved ejection fraction and concurrent hypertension, diabetes. 12 months- Up to 18 months from baseline
Other Risk stratification of HFpEF in patients with hypertension and diabetes using the echocardiographic and natriuretic peptide score from the HFA-PEFF algorithm. Risk stratification of heart failure with preserved ejection fraction in patients with hypertension and diabetes using the echocardiographic and natriuretic peptide score from the HFA-PEFF (Heart Failure Association- Pretest, Echocardiogaphic and Natriuretic peptide score, Functional testing and Final etiology) algorithm. This score ranges from 0 to 6, with higher score predicts worse outcome. At baseline
Other Risk stratification of heart failure with preserved ejection fraction in patients with hypertension and diabetes using the H2FPEF (Heavy, Hypertension, atrial Fibrillation, Pulmonary hypertension, Elder, Filling pressure) score. Risk stratification of heart failure with preserved ejection fraction in patients with hypertension and diabetes using the H2FPEF (Heavy, Hypertension, atrial Fibrillation, Pulmonary hypertension, Elder, Filling pressure) score. Maximum score is 9, minimum is 0. Higher score predicts worse outcome. At baseline
Other The correlation between echocardiographic and natriuretic peptide score from the HFA-PEFF algorithm and time to composite endpoint (all-cause mortality or HHF) The correlation between echocardiographic and natriuretic peptide score from the HFA-PEFF (Heart Failure Association- Pretest, Echocardiographic and Natriuretic peptide score, Functional testing and Final etiology) algorithm and time to composite endpoint (all-cause mortality and HHF) in patients with heart failure with preserved ejection fraction and concurrent hypertension, diabetes. 12 months- Up to 18 months from baseline
Other The correlation between H2FPEF (Heavy, Hypertension, atrial Fibrillation, Pulmonary hypertension, Elder, Filling pressure) score and time to composite endpoint (all-cause mortality and HHF) The correlation between H2FPEF score (Heavy, Hypertension, atrial Fibrillation, Pulmonary hypertension, Elder, Filling pressure) and time to composite endpoint (all-cause mortality and HHF) in patients with heart failure with preserved ejection fraction and concurrent hypertension, diabetes. 12 months- Up to 18 months from baseline
Other Comparing diagnostic criteria for heart failure with preserved ejection fraction using 2016 ESC guideline, HFA-PEFF score and H2FPEF score in patients with hypertension and diabetes. Comparing diagnostic criteria for heart failure with preserved ejection fraction using 2016 ESC (European Society of Cardiology) guideline, HFA-PEFF (Heart Failure Association- Pretest, Echocardiographic and Natriuretic peptide score, Functional testing and Final etiology) algorithm and H2FPEF (Heavy, Hypertension, atrial Fibrillation, Pulmonary hypertension, Elder, Filling pressure) score in patients with hypertension and diabetes. At baseline
Other The prevalence of undiagnosed heart failure with preserved ejection fraction in patients with hypertension and diabetes presenting with signs and symptoms of heart failure. The prevalence of undiagnosed heart failure with preserved ejection fraction in patients with hypertension and diabetes presenting with signs and symptoms of heart failure. At baseline
Other The prevalence of chronic kidney disease, persistent albuminuria, coronary artery disease, atrial fibrillation, and anemia in patients with heart failure with preserved ejection fraction and concurrent hypertension and diabetes The prevalence of chronic kidney disease, persistent albuminuria, coronary artery disease, atrial fibrillation, and anemia in patients with heart failure with preserved ejection fraction and concurrent hypertension and diabetes At baseline
Other The incidence of chronic kidney disease, persistent albuminuria, coronary artery disease, atrial fibrillation and anemia in patients with heart failure with preserved ejection fraction and concurrent hypertension and diabetes The incidence of chronic kidney disease, persistent albuminuria, coronary artery disease, atrial fibrillation and anemia in patients with heart failure with preserved ejection fraction and concurrent hypertension and diabetes 12 months- Up to 18 months from baseline
Other The correlation between baseline chronic kidney disease, persistent albuminuria, coronary artery disease, atrial fibrillation, anemia and mortality in patients with diabetes, hypertension and heart failure with preserved ejection fraction The correlation between baseline chronic kidney disease, persistent albuminuria, coronary artery disease, atrial fibrillation, anemia and mortality in patients with diabetes, hypertension and heart failure with preserved ejection fraction 12 months- Up to 18 months from baseline
Other Change in ejection fraction overtime in patients with heart failure with preserved ejection fraction and concurrent hypertension and diabetes Change in ejection fraction overtime in patients with heart failure with preserved ejection fraction and concurrent hypertension and diabetes 12 months- Up to 18 months from baseline
Other Change in structural abnormality on echocardiogram overtime in patients with heart failure with preserved ejection fraction and concurrent hypertension and diabetes Change in structural abnormality on echocardiogram overtime in patients with heart failure with preserved ejection fraction and concurrent hypertension and diabetes 12 months- Up to 18 months from baseline
Other Change in severity of diastolic dysfunction overtime in patients with heart failure with preserved ejection fraction and concurrent hypertension and diabetes Change in severity of diastolic dysfunction overtime in patients with heart failure with preserved ejection fraction and concurrent hypertension and diabetes 12 months- Up to 18 months from baseline
Other The correlation between baseline level of NT-proBNP and composite endpoint (all-cause mortality and HHF) in patients with diabetes, hypertension and heart failure with preserved ejection fraction The correlation between baseline level of NT-proBNP and composite endpoint (all-cause mortality and HHF) in patients with diabetes, hypertension and heart failure with preserved ejection fraction 12 months- Up to 18 months from baseline
Other The correlation between change in NT-proBNP level overtime and composite endpoint (all-cause mortality and HHF) in patients with diabetes, hypertension and heart failure with preserved ejection fraction The correlation between change in NT-proBNP level overtime and composite endpoint (all-cause mortality and HHF) in patients with diabetes, hypertension and heart failure with preserved ejection fraction 12 months- Up to 18 months from baseline
Other Change in eGFR overtime in patients with heart failure with preserved ejection fraction and concurrent hypertension and diabetes Change in eGFR overtime in patients with heart failure with preserved ejection fraction and concurrent hypertension and diabetes 12 months- Up to 18 months from baseline
Other Simultaneous risk factor control (HbA1c (%), and LDL-c (mmol/L), and blood pressure (mmHg)) in patients with diabetes, hypertension and heart failure with preserved ejection fraction Simultaneous risk factor control (HbA1c (%), and LDL-c (mmol/L), and blood pressure (mmHg)) in patients with diabetes, hypertension and heart failure with preserved ejection fraction 12 months- Up to 18 months from baseline
Other Change in simultaneous risk factor control (HbA1c (%), and LDL-c (mmol/L), and blood pressure (mmHg)) overtime in patients with diabetes, hypertension and heart failure with preserved ejection fraction Change in simultaneous risk factor control (HbA1c (%), and LDL-c (mmol/L), and blood pressure (mmHg)) in patients with diabetes, hypertension and heart failure with preserved ejection fraction 12 months- Up to 18 months from baseline
Other The correlation between simultaneous risk factor control and composite endpoint (all-cause mortality and HHF) in patients with diabetes, hypertension and heart failure with preserved ejection fraction The correlation between simultaneous risk factor control and composite endpoint (all-cause mortality and HHF) in patients with diabetes, hypertension and heart failure with preserved ejection fraction 12 months- Up to 18 months from baseline
Other The correlation between simultaneous risk factor control (HbA1c (%), and LDL-c (mmol/L), and blood pressure (mmHg)) and mortality in patients with diabetes, hypertension and heart failure with preserved ejection fraction The correlation between simultaneous risk factor control (HbA1c (%), and LDL-c (mmol/L), and blood pressure (mmHg)) and mortality in patients with diabetes, hypertension and heart failure with preserved ejection fraction 12 months- Up to 18 months from baseline
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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