Ignite Creation Date:
2024-05-06 @ 12:35 PM
Last Modification Date:
2024-10-26 @ 1:01 PM
Study NCT ID:
NCT03794518
Status:
UNKNOWN
Last Update Posted:
2019-01-07
First Post:
2018-08-01
Brief Title:
Effect of Dapagliflozin Plus Low Dose Pioglitazone on Hospitalization Rate in Patients With HF and HFpEF
Sponsor:
Hamad Medical Corporation
Organization:
Hamad Medical Corporation
Study Overview
Official Title:
Effect of Combination Therapy With Dapagliflozin Plus Low Dose Pioglitazone on Hospitalization Rate in Patients With Heart Failure and Preserved Left Ventricular Ejection Fraction
Status:
UNKNOWN
Status Verified Date:
2018-07
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The prevalence of type 2 diabetes mellitus T2DM in Qatar and nations worldwide has increased in recent decades into epidemic proportions Cardiovascular CVD disease is the leading cause of death in T2DM patients Approximately 80 of T2DM patients will die because of CV cause Congestive heart failure CHF is a major cause of CV death in T2DM and it also is responsible for significant morbidity and health care expenditure due to high rate of hospitalization for heart failure
Detailed Description:
Community based studies have demonstrated similar prevalence of HF with reduced ejection fraction HFpEF and HF with reduced LV function HFrEF in patients hospitalized for CHF Moreover the prevalence of HFrEF is declining over the past two decades whereas that of HFpEF is progressively increasing Progressive increase in obesity and T2DM prevalence is likely among the principal factors responsible for the steady increase in HFpEF prevalence
The aims of the present study are to examine whether therapies that correct the myocardial metabolic abnormalities present in subjects with T2DM and diastolic dysfunction improve myocardial diastolic dysfunction and reduce the rate of hospitalizations in patients with HFpEF
The primary objective of the study is to examine the effect of combination therapy with pioglitazone 15 mg plus dapagliflozin 10 mg versus placebo on hospitalization for heart failure in patients with HFpEF
Eligible subjects who consent for participating in the study will be seen by the study coordinator Medical history and physical examination will be performed Each subject will receive the following measurements
Medical history and physical examination including weight height waist blood pressure and pulse
Blood tests
Screening CBC Blood chemistry fasting plasma glucose concentration HbA1c renal and liver function lipid profile TSH serum iron iron biding capacity and ferritin
Plasma metabolites ketone lactate bicarbonate venous PH and plasma free fatty acid
Hormones insulin C-peptide glucagon NT proBNP angiotensin II plasma renin activity and aldosterone
Inflammatory markers adiponectin hsCRP IL-2 IL-6 and IL-12 F2-isoprostane oxidized LDL
Vascular Measurements Measurement of pulse wave velocity and central aortic pulse pressure with sphygmocor
Measurement of total body fat mass with Bioimpedence Echocardiography
Patients will be consented on the day of discharge or during the outpatient visit in the Cardiology Clinic Consented patients will be referred to the CRC within one week to perform the echocardiography and vascular measurements Patients will be asked to come to CRC after overnight fast and blood samples will be drawn for the above mentioned blood tests after which echocardiography and vascular measurements will be performed
Randomization and Intervention
After completing the baseline studies patients will be randomized into two groups to receive in a double blind fashion
Group 1 combination of pioglitazone plus dapagliflozin or Group 2 Placebo Beta blockers ACEI ARB and aldosterone
Patients in both groups will be matched for age gender BMI HbA1c systolic BP and LVEF Randomization will be made by the pharmacist at the Heart Hospital and the randomization code will be maintained at the hospital pharmacy Patients will be randomized in blocks of 4 while the group means are matched for the above parameters
The aims of the present study are to examine whether therapies that correct the myocardial metabolic abnormalities present in subjects with T2DM and diastolic dysfunction improve myocardial diastolic dysfunction and reduce the rate of hospitalizations in patients with HFpEF
The primary objective of the study is to examine the effect of combination therapy with pioglitazone 15 mg plus dapagliflozin 10 mg versus placebo on hospitalization for heart failure in patients with HFpEF
Eligible subjects who consent for participating in the study will be seen by the study coordinator Medical history and physical examination will be performed Each subject will receive the following measurements
Medical history and physical examination including weight height waist blood pressure and pulse
Blood tests
Screening CBC Blood chemistry fasting plasma glucose concentration HbA1c renal and liver function lipid profile TSH serum iron iron biding capacity and ferritin
Plasma metabolites ketone lactate bicarbonate venous PH and plasma free fatty acid
Hormones insulin C-peptide glucagon NT proBNP angiotensin II plasma renin activity and aldosterone
Inflammatory markers adiponectin hsCRP IL-2 IL-6 and IL-12 F2-isoprostane oxidized LDL
Vascular Measurements Measurement of pulse wave velocity and central aortic pulse pressure with sphygmocor
Measurement of total body fat mass with Bioimpedence Echocardiography
Patients will be consented on the day of discharge or during the outpatient visit in the Cardiology Clinic Consented patients will be referred to the CRC within one week to perform the echocardiography and vascular measurements Patients will be asked to come to CRC after overnight fast and blood samples will be drawn for the above mentioned blood tests after which echocardiography and vascular measurements will be performed
Randomization and Intervention
After completing the baseline studies patients will be randomized into two groups to receive in a double blind fashion
Group 1 combination of pioglitazone plus dapagliflozin or Group 2 Placebo Beta blockers ACEI ARB and aldosterone
Patients in both groups will be matched for age gender BMI HbA1c systolic BP and LVEF Randomization will be made by the pharmacist at the Heart Hospital and the randomization code will be maintained at the hospital pharmacy Patients will be randomized in blocks of 4 while the group means are matched for the above parameters
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None