Clinical trial NCT04835194: Phenotypes and Outcomes of Heart Failure With Preserved Ejection Fraction in Patients With Hypertension and Diabetes
Official title: Clinical Phenotypes of Heart Failure With Preserved Ejection Fraction and Its Association With Cardiovascular Outcomes in Patients With Hypertension and Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure With Preserved Ejection Fraction
Diabetes Mellitus, Type 2
Hypertension
Keywords: Heart failure with preserved ejection fraction
Diabetes Mellitus, Type 2
Hypertension
Lead sponsor: University of Medicine and Pharmacy at Ho Chi Minh City
Sponsor class: OTHER
First posted: 2021-04-08
Enrollment: 233
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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).

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 (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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Phenotypes of heart failure with preserved ejection fraction in patients with concurrent hypertension and diabetes.
timeFrame: At baseline
measure: Composite primary endpoint
timeFrame: 12 months - Up to 18 months from baseline
measure: Combined endpoint
timeFrame: 12 months - Up to 18 months from baseline
measure: The correlation between clinical phenotypes and composite primary endpoint
timeFrame: 12 months- Up to 18 months from baseline
measure: The correlation between clinical phenotypes and combined endpoint
timeFrame: 12 months- Up to 18 months from baseline
Secondary outcomes:
measure: Occurence of HHF (first and recurrent) in patients with heart failure with preserved ejection fraction and concurrent hypertension, diabetes.
timeFrame: 12 months- Up to 18 months from baseline
measure: All cause mortality in patients with heart failure with preserved ejection fraction and concurrent hypertension, diabetes.
timeFrame: 12 months- Up to 18 months from baseline
measure: Cardiovascular mortality in patients with heart failure with preserved ejection fraction and concurrent hypertension, diabetes.
timeFrame: 12 months- Up to 18 months from baseline
measure: Time to first occurence of HHF (first and recurrent) in patients with heart failure with preserved ejection fraction and concurrent hypertension, diabetes.
timeFrame: 12 months- Up to 18 months from baseline
measure: Time to first all cause mortality in patients with heart failure with preserved ejection fraction and concurrent hypertension, diabetes
timeFrame: 12 months- Up to 18 months from baseline
measure: Time to first cardiovascular mortality in patients with heart failure with preserved ejection fraction and concurrent hypertension, diabetes.
timeFrame: 12 months- Up to 18 months from baseline
Other outcomes:
measure: 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.
timeFrame: 12 months- Up to 18 months from baseline
measure: The correlation between clinical phenotypes and time to all cause mortality in patients with heart failure with preserved ejection fraction and concurrent hypertension, diabetes.
timeFrame: 12 months- Up to 18 months from baseline
measure: The correlation between clinical phenotypes and time to cardiovascular mortality in patients with heart failure with preserved ejection fraction and concurrent hypertension, diabetes.
timeFrame: 12 months- Up to 18 months from baseline
measure: 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.
timeFrame: 12 months- Up to 18 months from baseline
measure: The correlation between clinical phenotypes and all cause mortality in patients with heart failure with preserved ejection fraction and concurrent hypertension, diabetes.
timeFrame: 12 months- Up to 18 months from baseline
measure: The correlation between clinical phenotypes and cardiovascular mortality in patients with heart failure with preserved ejection fraction and concurrent hypertension, diabetes.
timeFrame: 12 months- Up to 18 months from baseline
measure: 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.
timeFrame: 12 months- Up to 18 months from baseline
measure: The correlation between clinical phenotypes and non-cardiovascular mortality in patients with heart failure with preserved ejection fraction and concurrent hypertension, diabetes.
timeFrame: 12 months- Up to 18 months from baseline
measure: The correlation between clinical phenotypes and non-cardiovascular hospitalization in patients with heart failure with preserved ejection fraction and concurrent hypertension, diabetes.
timeFrame: 12 months- Up to 18 months from baseline
measure: Risk stratification of HFpEF in patients with hypertension and diabetes using the echocardiographic and natriuretic peptide score from the HFA-PEFF algorithm.
timeFrame: At baseline
measure: 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.
timeFrame: At baseline
measure: The correlation between echocardiographic and natriuretic peptide score from the HFA-PEFF algorithm and time to composite endpoint (all-cause mortality or HHF)
timeFrame: 12 months- Up to 18 months from baseline
measure: The correlation between H2FPEF (Heavy, Hypertension, atrial Fibrillation, Pulmonary hypertension, Elder, Filling pressure) score and time to composite endpoint (all-cause mortality and HHF)
timeFrame: 12 months- Up to 18 months from baseline
measure: 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.
timeFrame: At baseline
measure: The prevalence of undiagnosed heart failure with preserved ejection fraction in patients with hypertension and diabetes presenting with signs and symptoms of heart failure.
timeFrame: At baseline
measure: 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
timeFrame: At baseline
measure: 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
timeFrame: 12 months- Up to 18 months from baseline
measure: 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
timeFrame: 12 months- Up to 18 months from baseline
measure: Change in ejection fraction overtime in patients with heart failure with preserved ejection fraction and concurrent hypertension and diabetes
timeFrame: 12 months- Up to 18 months from baseline
measure: Change in structural abnormality on echocardiogram overtime in patients with heart failure with preserved ejection fraction and concurrent hypertension and diabetes
timeFrame: 12 months- Up to 18 months from baseline
measure: Change in severity of diastolic dysfunction overtime in patients with heart failure with preserved ejection fraction and concurrent hypertension and diabetes
timeFrame: 12 months- Up to 18 months from baseline
measure: 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
timeFrame: 12 months- Up to 18 months from baseline
measure: 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
timeFrame: 12 months- Up to 18 months from baseline
measure: Change in eGFR overtime in patients with heart failure with preserved ejection fraction and concurrent hypertension and diabetes
timeFrame: 12 months- Up to 18 months from baseline
measure: 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
timeFrame: 12 months- Up to 18 months from baseline
measure: 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
timeFrame: 12 months- Up to 18 months from baseline
measure: 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
timeFrame: 12 months- Up to 18 months from baseline
measure: 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
timeFrame: 12 months- Up to 18 months from baseline
Locations:
city: Ho Chi Minh City
country: Vietnam
facility: Nhan Dan Gia Dinh Hospital
state: Ho Chi Minh
city: Ho Chi Minh City
country: Vietnam
facility: University Medical Center
Study officials:
affiliation: University of Medicine and Pharmacy at Ho Chi Minh City
name: Van Ngoc-Thanh Nguyen, MD, MSci
role: PRINCIPAL_INVESTIGATOR
References: