Risk ReductionPhase 3NCT03794518
Effect of Dapagliflozin Plus Low Dose Pioglitazone on Hospitalization Rate in Patients With HF and HFpEF
A Phase 3 study testing Pioglitazone Plus dapaglifliozin in people with Risk Reduction, run by Hamad Medical Corporation at 1 site in Qatar.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Risk Reduction
- What is being tested?
- Pioglitazone Plus dapaglifliozin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 648 participants
- Where
- 1 siteQatar
- Study dates
- Mar 2019to Dec 2021
- Phase
- Phase 3
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of type 2 diabetes according to the ADA criteria.
- Drug naïve or on stable dose of antidiabetic therapy (oral agents and/or insulin) for 3 months preceding recruitment.
- Hospitalized for HFpEF (defined as hospitalization require intravenous diuresis) in the 6 months preceding recruitment.
- eGFR >60 ml/min
- LVEF >50%
- Presence of LV diastolic dysfunction in echocardiography
- We have limited the inclusion criteria in the present study to T2DM patients with HFpEF and evidence of diastolic dysfunction by echocardiography in order to select a homogenous group of HFpEF patients with similar etiology, likely "metabolic HFpEF". We believe that this subgroup of HFpEF will benefit most from treatment with low dose pioglitazone (15 mg) plus dapagliflozin (10 mg).
Who cannot join
- Treatment with pioglitazone or SGLT2 inhibitor in the 3 months prior to recruitment.
- eGFR < 60 ml/min
- LVEF <50%;
- Valvular heart disease, ASD, VSD
- Chronic lung disease
- Cancer
Show all 9Show fewer
- diabetes mellitus type 1
- patients with acute coronary syndrome, stroke or transient ischemic attack in the preceding 6 months
- pregnancy or lactation period
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Conditions
- Risk Reduction
- Being tested
- Pioglitazone Plus dapaglifliozin, Placebo
- Medical subject headings
- Risk Reduction Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pioglitazone Plus dapaglifliozinDrug
Pioglitazone Plus dapaglifliozin
PlaceboDrug
(Beta blockers, ACEI, ARB, and aldosterone )
| Study group | Role | What they receive |
|---|---|---|
| Pioglitazone Plus dapaglifliozin | Experimental | Pioglitazone 15mg and dapaglifliozin 10mg together in T2DM patients having HF and HFpEF conditions Receives: Drug: Pioglitazone Plus dapaglifliozin |
| Placebo | Placebo comparator | Beta blockers, ACEI, ARB, and aldosterone Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first hospitalization for heart failure after starting intervention
Hospitalization for heart failure will be defined as a hospitalization >24 hours requiring intravenous diuretic infusion.
Measured: 3 years
Secondary outcomes (1)
Number of all cause mortality
Composite outcome comprised of total mortality, incidence of acute coronary syndrome and non fatal CVA
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2019
- Study startMar 2019 (estimated)
- Primary completionSep 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Risk ReductionStudies of the same condition, open and under way.
- More trials run by Hamad Medical CorporationThe 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pioglitazone (15 mg) and dapagliflozin (10mg) vs Placebo
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 648 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hamad Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nidal Asaad, MD, Principal investigator, Heart Hospital, HMC, Doha, Qatar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03794518
- Sponsor's protocol ID
- IRGC-04-SI-17-116
- Status last verified
- Jul 2018
- First submitted
- 1 Aug 2018
- Last updated
- 7 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alharbi NS, Almutari R, Jones S, Al-Daghri N, Khunti K, de Lusignan S. Trends in the prevalence of type 2 diabetes mellitus and obesity in the Arabian Gulf States: systematic review and meta-analysis. Diabetes Res Clin Pract. 2014 Nov;106(2):e30-3. doi: 10.1016/j.diabres.2014.08.019. Epub 2014 Sep 6.
PubMed 25241351Shaw JE, Sicree RA, Zimmet PZ. Global estimates of the prevalence of diabetes for 2010 and 2030. Diabetes Res Clin Pract. 2010 Jan;87(1):4-14. doi: 10.1016/j.diabres.2009.10.007. Epub 2009 Nov 6.
PubMed 19896746American Diabetes Association. 9. Cardiovascular Disease and Risk Management. Diabetes Care. 2017 Jan;40(Suppl 1):S75-S87. doi: 10.2337/dc17-S012. No abstract available.
PubMed 27979896Bahrami H, Bluemke DA, Kronmal R, Bertoni AG, Lloyd-Jones DM, Shahar E, Szklo M, Lima JA. Novel metabolic risk factors for incident heart failure and their relationship with obesity: the MESA (Multi-Ethnic Study of Atherosclerosis) study. J Am Coll Cardiol. 2008 May 6;51(18):1775-83. doi: 10.1016/j.jacc.2007.12.048.
PubMed 18452784Kannel WB, Hjortland M, Castelli WP. Role of diabetes in congestive heart failure: the Framingham study. Am J Cardiol. 1974 Jul;34(1):29-34. doi: 10.1016/0002-9149(74)90089-7. No abstract available.
PubMed 4835750Nichols GA, Gullion CM, Koro CE, Ephross SA, Brown JB. The incidence of congestive heart failure in type 2 diabetes: an update. Diabetes Care. 2004 Aug;27(8):1879-84. doi: 10.2337/diacare.27.8.1879.
PubMed 15277411Gustafsson I, Brendorp B, Seibaek M, Burchardt H, Hildebrandt P, Kober L, Torp-Pedersen C; Danish Investigatord of Arrhythmia and Mortality on Dofetilde Study Group. Influence of diabetes and diabetes-gender interaction on the risk of death in patients hospitalized with congestive heart failure. J Am Coll Cardiol. 2004 Mar 3;43(5):771-7. doi: 10.1016/j.jacc.2003.11.024.
PubMed 14998615Pfeffer MA, Braunwald E, Moye LA, Basta L, Brown EJ Jr, Cuddy TE, Davis BR, Geltman EM, Goldman S, Flaker GC, et al. Effect of captopril on mortality and morbidity in patients with left ventricular dysfunction after myocardial infarction. Results of the survival and ventricular enlargement trial. The SAVE Investigators. N Engl J Med. 1992 Sep 3;327(10):669-77. doi: 10.1056/NEJM199209033271001.
PubMed 1386652Owan TE, Hodge DO, Herges RM, Jacobsen SJ, Roger VL, Redfield MM. Trends in prevalence and outcome of heart failure with preserved ejection fraction. N Engl J Med. 2006 Jul 20;355(3):251-9. doi: 10.1056/NEJMoa052256.
PubMed 16855265Shah SJ, Katz DH, Selvaraj S, Burke MA, Yancy CW, Gheorghiade M, Bonow RO, Huang CC, Deo RC. Phenomapping for novel classification of heart failure with preserved ejection fraction. Circulation. 2015 Jan 20;131(3):269-79. doi: 10.1161/CIRCULATIONAHA.114.010637. Epub 2014 Nov 14.
PubMed 25398313Johnsson K, Johnsson E, Mansfield TA, Yavin Y, Ptaszynska A, Parikh SJ. Osmotic diuresis with SGLT2 inhibition: analysis of events related to volume reduction in dapagliflozin clinical trials. Postgrad Med. 2016 May;128(4):346-55. doi: 10.1080/00325481.2016.1153941. Epub 2016 Mar 2.
PubMed 26878357Liu C, Liu T, Li G. Pioglitazone may offer therapeutic advantages in diabetes-related atrial fibrillation. Int J Cardiol. 2013 Sep 30;168(2):1603-5. doi: 10.1016/j.ijcard.2013.01.037. Epub 2013 Feb 12. No abstract available.
PubMed 23414743Liu B, Wang J, Wang G. Beneficial effects of pioglitazone on retardation of persistent atrial fibrillation progression in diabetes mellitus patients. Int Heart J. 2014;55(6):499-505. doi: 10.1536/ihj.14-107. Epub 2014 Oct 14.
PubMed 25310928Sulaiman K, Panduranga P, Al-Zakwani I, Alsheikh-Ali AA, AlHabib KF, Al-Suwaidi J, Al-Mahmeed W, AlFaleh H, Elasfar A, Al-Motarreb A, Ridha M, Bulbanat B, Al-Jarallah M, Bazargani N, Asaad N, Amin H. Clinical characteristics, management, and outcomes of acute heart failure patients: observations from the Gulf acute heart failure registry (Gulf CARE). Eur J Heart Fail. 2015 Apr;17(4):374-84. doi: 10.1002/ejhf.245. Epub 2015 Mar 4.
PubMed 25739882Abdul-Ghani M, Migahid O, Megahed A, Adams J, Triplitt C, DeFronzo RA, Zirie M, Jayyousi A. Erratum. Combination Therapy With Exenatide Plus Pioglitazone Versus Basal/Bolus Insulin in Patients With Poorly Controlled Type 2 Diabetes on Sulfonylurea Plus Metformin: The Qatar Study. Diabetes Care 2017;40:325-331. Diabetes Care. 2017 Aug;40(8):1134. doi: 10.2337/dc17-er08d. Epub 2017 Jun 14. No abstract available.
PubMed 28615237
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03794518
- Acronym / sponsor ID
- IRGC-04-SI-17-116
- Conditions
- Risk Reduction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 648 participants (estimated)
- Lead sponsor
- Hamad Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- Mar 2019 (estimated)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 7 Jan 2019 (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.
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
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Pioglitazone (15 mg) and dapagliflozin (10mg) vs Placebo
| Arm | Type | Receives |
|---|---|---|
| Pioglitazone Plus dapaglifliozin | Experimental | Drug: Pioglitazone Plus dapaglifliozinPioglitazone 15mg and dapaglifliozin 10mg together in T2DM patients having HF and HFpEF conditions |
| Placebo | Placebo comparator | Drug: PlaceboBeta blockers, ACEI, ARB, and aldosterone |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosis of type 2 diabetes according to the ADA criteria.
- Drug naïve or on stable dose of antidiabetic therapy (oral agents and/or insulin) for 3 months preceding recruitment.
- Hospitalized for HFpEF (defined as hospitalization require intravenous diuresis) in the 6 months preceding recruitment.
- eGFR >60 ml/min
- LVEF >50%
Key exclusion criteria (9 listed)
- Treatment with pioglitazone or SGLT2 inhibitor in the 3 months prior to recruitment.
- eGFR < 60 ml/min
- LVEF <50%;
- Valvular heart disease, ASD, VSD
- Chronic lung disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pioglitazone Plus dapaglifliozinPioglitazone Plus dapaglifliozin | Drug | Pioglitazone Plus dapaglifliozin |
| Placebo(Beta blockers, ACEI, ARB, and aldosterone ) | Drug | Placebo |
Primary outcome
Time to first hospitalization for heart failure after starting intervention
Time frame: 3 years
Hospitalization for heart failure will be defined as a hospitalization >24 hours requiring intravenous diuretic infusion.
1 secondary outcome
Number of all cause mortality
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2019.
- Results publication: PubMed 25241351Alharbi NS, Almutari R, Jones S, Al-Daghri N, Khunti K, de Lusignan S. Trends in the prevalence of type 2 diabetes mellitus and obesity in the Arabian Gulf States: systematic review and meta-analysis. Diabetes Res Clin Pract. 2014 Nov;106(2):e30-3. doi: 10.1016/j.diabres.2014.08.019. Epub 2014 Sep 6.
- Results publication: PubMed 19896746Shaw JE, Sicree RA, Zimmet PZ. Global estimates of the prevalence of diabetes for 2010 and 2030. Diabetes Res Clin Pract. 2010 Jan;87(1):4-14. doi: 10.1016/j.diabres.2009.10.007. Epub 2009 Nov 6.
- Results publication: PubMed 27979896American Diabetes Association. 9. Cardiovascular Disease and Risk Management. Diabetes Care. 2017 Jan;40(Suppl 1):S75-S87. doi: 10.2337/dc17-S012. No abstract available.
- Results publication: PubMed 18452784Bahrami H, Bluemke DA, Kronmal R, Bertoni AG, Lloyd-Jones DM, Shahar E, Szklo M, Lima JA. Novel metabolic risk factors for incident heart failure and their relationship with obesity: the MESA (Multi-Ethnic Study of Atherosclerosis) study. J Am Coll Cardiol. 2008 May 6;51(18):1775-83. doi: 10.1016/j.jacc.2007.12.048.
- Results publication: PubMed 4835750Kannel WB, Hjortland M, Castelli WP. Role of diabetes in congestive heart failure: the Framingham study. Am J Cardiol. 1974 Jul;34(1):29-34. doi: 10.1016/0002-9149(74)90089-7. No abstract available.
- Results publication: PubMed 15277411Nichols GA, Gullion CM, Koro CE, Ephross SA, Brown JB. The incidence of congestive heart failure in type 2 diabetes: an update. Diabetes Care. 2004 Aug;27(8):1879-84. doi: 10.2337/diacare.27.8.1879.
- Results publication: PubMed 14998615Gustafsson I, Brendorp B, Seibaek M, Burchardt H, Hildebrandt P, Kober L, Torp-Pedersen C; Danish Investigatord of Arrhythmia and Mortality on Dofetilde Study Group. Influence of diabetes and diabetes-gender interaction on the risk of death in patients hospitalized with congestive heart failure. J Am Coll Cardiol. 2004 Mar 3;43(5):771-7. doi: 10.1016/j.jacc.2003.11.024.
- Results publication: PubMed 1386652Pfeffer MA, Braunwald E, Moye LA, Basta L, Brown EJ Jr, Cuddy TE, Davis BR, Geltman EM, Goldman S, Flaker GC, et al. Effect of captopril on mortality and morbidity in patients with left ventricular dysfunction after myocardial infarction. Results of the survival and ventricular enlargement trial. The SAVE Investigators. N Engl J Med. 1992 Sep 3;327(10):669-77. doi: 10.1056/NEJM199209033271001.
- Results publication: PubMed 16855265Owan TE, Hodge DO, Herges RM, Jacobsen SJ, Roger VL, Redfield MM. Trends in prevalence and outcome of heart failure with preserved ejection fraction. N Engl J Med. 2006 Jul 20;355(3):251-9. doi: 10.1056/NEJMoa052256.
- Results publication: PubMed 25398313Shah SJ, Katz DH, Selvaraj S, Burke MA, Yancy CW, Gheorghiade M, Bonow RO, Huang CC, Deo RC. Phenomapping for novel classification of heart failure with preserved ejection fraction. Circulation. 2015 Jan 20;131(3):269-79. doi: 10.1161/CIRCULATIONAHA.114.010637. Epub 2014 Nov 14.
- Results publication: PubMed 26878357Johnsson K, Johnsson E, Mansfield TA, Yavin Y, Ptaszynska A, Parikh SJ. Osmotic diuresis with SGLT2 inhibition: analysis of events related to volume reduction in dapagliflozin clinical trials. Postgrad Med. 2016 May;128(4):346-55. doi: 10.1080/00325481.2016.1153941. Epub 2016 Mar 2.
- Results publication: PubMed 23414743Liu C, Liu T, Li G. Pioglitazone may offer therapeutic advantages in diabetes-related atrial fibrillation. Int J Cardiol. 2013 Sep 30;168(2):1603-5. doi: 10.1016/j.ijcard.2013.01.037. Epub 2013 Feb 12. No abstract available.
- Individual participant dataSharing planned: No
Related trials for Risk Reduction
RecruitingPhase 1
IL-17 Blockade to Decrease irAEs (REPLAY)
Metastatic Melanoma
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Recruiting
A Study to Compare Two Surgical Procedures in Individuals With BRCA1 Mutations to Assess Reduced Risk of Ovarian Cancer
Ovarian Carcinoma
Not yet recruiting
Reducing Exposure With Air Cleaners and Technology
Asthma, COPD (Chronic Obstructive Pulmonary Disease)
Active, not recruiting
Eat, Move, Live Program for the Reduction of Cancer and Chronic Disease Risk in Underserved Communities
Diabetes Mellitus, Obesity-Related Malignant Neoplasm
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.
Nidal Asaad, MD principal investigator
Heart Hospital, HMC, Doha, Qatar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pioglitazone Plus dapaglifliozin in people with Risk Reduction, run by Hamad Medical Corporation at 1 site in Qatar.
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 7 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 7 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Qatar. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nidal Asaad, MD (44395578, nasaad@hamad.qa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to first hospitalization for heart failure after starting intervention (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03794518, which also lists 16 linked publications.
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 7 Jan 2019.