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

NCT04835194 | Completed DMC

• 1 other identifier: 2129-ĐHYD
• Study Type: observational
• Target: 233
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

Heart failure with preserved ejection fraction; Diabetes Mellitus, Type 2; Hypertension

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (6)

• 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.

  12 months- Up to 18 months from baseline

• Cardiovascular 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.

  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

  12 months- Up to 18 months from baseline

Other Outcomes (28)

• 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.

  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.

  12 months- Up to 18 months from baseline

Study Arms (3)

Phenotype 1 (from LCA)

Phenotype 2 (from LCA)

Phenotype 3 (from LCA)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Medicine and Pharmacy at Ho Chi Minh City: lead

Study Sites (2)

Nhan Dan Gia Dinh Hospital

Ho Chi Minh City, Ho Chi Minh, 700 000, Vietnam

Location

University Medical Center

Ho Chi Minh City, 700000, Vietnam

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Hypertension

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Van Ngoc-Thanh Nguyen, MD, MSci

  University of Medicine and Pharmacy at Ho Chi Minh City

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator: Van Ngoc-Thanh Nguyen, MD, MSci

Study Record Dates

• First Submitted: April 3, 2021
• First Posted: April 8, 2021
• Study Start: December 1, 2020
• Primary Completion: January 1, 2023
• Study Completion: February 28, 2023
• Last Updated: March 2, 2023

Record last verified: 2023-02

Locations

VN (2)