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

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

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.

Study Overview

• Status: Completed
• Conditions: Hypertension; Diabetes Mellitus, Type 2; Heart Failure With Preserved Ejection Fraction

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 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 (Actual): 233

Contacts and Locations

Study Locations

• Vietnam
  • Ho Chi Minh City, Vietnam, 700000
    • University Medical Center
  • Ho Chi Minh
    • Ho Chi Minh City, Ho Chi Minh, Vietnam, 700 000
      • Nhan Dan Gia Dinh Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients attending the outpatient clinic and/or hospital ward in two tertiary hospitals (University Medical Center, Nhan Dan Gia Dinh hospital) and one heart center (Heart Institute in Ho Chi Minh city).

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Phenotype 1 (from LCA)
Phenotype 2 (from LCA)
Phenotype 3 (from LCA)

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: University of Medicine and Pharmacy at Ho Chi Minh City
• Investigators: Principal Investigator: Van Ngoc-Thanh Nguyen, MD, MSci, University of Medicine and Pharmacy at Ho Chi Minh City

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Actual): January 1, 2023
• Study Completion (Actual): February 28, 2023

Study Registration Dates

• First Submitted: April 3, 2021
• First Submitted That Met QC Criteria: April 5, 2021
• First Posted (Actual): April 8, 2021

Study Record Updates

• Last Update Posted (Actual): March 2, 2023
• Last Update Submitted That Met QC Criteria: February 28, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Hypertension; Diabetes Mellitus, Type 2; Heart failure with preserved ejection fraction
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Heart Failure; Hypertension; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 2129-ĐHYD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No