Phenotypes and Outcomes of Heart Failure With Preserved Ejection Fraction in Patients With Hypertension and Diabetes
NCT ID: NCT04835194
Last Updated: 2023-03-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
233 participants
OBSERVATIONAL
2020-12-01
2023-02-28
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Phenotype 1 (from LCA)
No interventions assigned to this group
Phenotype 2 (from LCA)
No interventions assigned to this group
Phenotype 3 (from LCA)
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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)
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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University of Medicine and Pharmacy at Ho Chi Minh City
OTHER
Responsible Party
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Van Ngoc-Thanh Nguyen
Principle investigator: Van Ngoc-Thanh Nguyen, MD, MSci
Principal Investigators
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Van Ngoc-Thanh Nguyen, MD, MSci
Role: PRINCIPAL_INVESTIGATOR
University of Medicine and Pharmacy at Ho Chi Minh City
Locations
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Nhan Dan Gia Dinh Hospital
Ho Chi Minh City, Ho Chi Minh, Vietnam
University Medical Center
Ho Chi Minh City, , Vietnam
Countries
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Other Identifiers
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2129-ĐHYD
Identifier Type: -
Identifier Source: org_study_id
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