Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Other |
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 |
|
Other |
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 |
|
Other |
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 |
|
Other |
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 |
|
Other |
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 |
|
Other |
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 |
|
Other |
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 |
|
Other |
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 |
|
Other |
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 |
|
Other |
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 |
|
Other |
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 |
|
Other |
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 |
|
Other |
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 |
|
Other |
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 |
|
Other |
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 |
|
Other |
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 |
|
Other |
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 |
|
Other |
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 |
|
Other |
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 |
|
Other |
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 |
|
Other |
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 |
|
Other |
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 |
|
Other |
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 |
|
Other |
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 |
|
Other |
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 |
|
Other |
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 |
|
Other |
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 |
|
Other |
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 |
|
Primary |
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 |
|
Primary |
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 |
|
Primary |
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 |
|
Primary |
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 |
|
Primary |
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 |
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 |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
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 |
|
Secondary |
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 |
|