Heart Failure With Preserved Ejection FractionNCT04835194
Phenotypes and Outcomes of Heart Failure With Preserved Ejection Fraction in Patients With Hypertension and Diabetes
An observational study of Heart Failure With Preserved Ejection Fraction and Diabetes Mellitus, Type 2, run by University of Medicine and Pharmacy at Ho Chi Minh City at 2 sites in Vietnam.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure With Preserved Ejection Fraction, Diabetes Mellitus, Type 2, Hypertension
- How many people
- 233 participants
- Where
- 2 sitesVietnam
- Study dates
- 1 Dec 2020to 28 Feb 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
2 sites in 1 country.
Vietnam2 sites
Nhan Dan Gia Dinh Hospital
Ho Chi Minh City, Ho Chi Minh, 700 000
University Medical Center
Ho Chi Minh City, 700000
About this study
Official title: 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.
Read the 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.
- Keywords
- Heart failure with preserved ejection fraction, Diabetes Mellitus, Type 2, Hypertension
- Medical subject headings
- Diabetes Mellitus, Type 2, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Phenotype 1 (from LCA) | Not described | |
| Phenotype 2 (from LCA) | Not described | |
| Phenotype 3 (from LCA) | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Occurence of HHF (first and recurrent) in patients with heart failure with preserved ejection fraction and concurrent hypertension, diabetes.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 12 months- Up to 18 months from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start1 Dec 2020
- Primary completion1 Jan 2023
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Preserved Ejection FractionStudies of the same condition, open and under way.
- More trials run by University of Medicine and Pharmacy at Ho Chi Minh CityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 233 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Van Ngoc-Thanh Nguyen, University of Medicine and Pharmacy at Ho Chi Minh City
- Investigators
- Van Ngoc-Thanh Nguyen, MD, MSci, Principal investigator, University of Medicine and Pharmacy at Ho Chi Minh City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04835194
- Sponsor's protocol ID
- 2129-ĐHYD
- Status last verified
- Feb 2023
- First submitted
- 3 Apr 2021
- Last updated
- 2 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Phenotypes of Heart Failure With Preserved Ejection Fraction and Its Association With Cardiovascular Outcomes in Patients With Hypertension and Diabetes
- ClinicalTrials.gov ID
- NCT04835194
- Acronym / sponsor ID
- 2129-ĐHYD
- Keywords
- Heart failure with preserved ejection fraction, Diabetes Mellitus, Type 2, Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 233 participants (actual)
- Lead sponsor
- University of Medicine and Pharmacy at Ho Chi Minh CityUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 8 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phenotype 1 (from LCA) | – | – |
| Phenotype 2 (from LCA) | – | – |
| Phenotype 3 (from LCA) | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (8 listed)
- 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.
- Further inclusion criteria apply
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Phenotypes of heart failure with preserved ejection fraction in patients with concurrent hypertension and diabetes.
Time frame: At baseline
Phenotypes of heart failure with preserved ejection fraction in patients with concurrent hypertension and diabetes.
Composite primary endpoint
Time frame: 12 months - Up to 18 months from baseline
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.
Combined endpoint
Time frame: 12 months - Up to 18 months from baseline
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.
The correlation between clinical phenotypes and composite primary endpoint
Time frame: 12 months- Up to 18 months from baseline
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.
The correlation between clinical phenotypes and combined endpoint
Time frame: 12 months- Up to 18 months from baseline
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.
6 secondary outcomes
Occurence of HHF (first and recurrent) in patients with heart failure with preserved ejection fraction and concurrent hypertension, diabetes.
Time frame: 12 months- Up to 18 months from baseline
All cause mortality in patients with heart failure with preserved ejection fraction and concurrent hypertension, diabetes.
Time frame: 12 months- Up to 18 months from baseline
Cardiovascular mortality in patients with heart failure with preserved ejection fraction and concurrent hypertension, diabetes.
Time frame: 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 frame: 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 frame: 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 frame: 12 months- Up to 18 months from baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Van Ngoc-Thanh Nguyen, MD, MSci principal investigator
University of Medicine and Pharmacy at Ho Chi Minh City
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure With Preserved Ejection Fraction and Diabetes Mellitus, Type 2, run by University of Medicine and Pharmacy at Ho Chi Minh City at 2 sites in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phenotypes of heart failure with preserved ejection fraction in patients with concurrent hypertension and diabetes. (time frame: At baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2023.