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Effect of Dapagliflozin Plus Low Dose Pioglitazone on Hospitalization Rate in Patients With HF and HFpEF

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ClinicalTrials.gov Identifier: NCT03794518
Recruitment Status : Not yet recruiting
First Posted : January 7, 2019
Last Update Posted : January 7, 2019
Sponsor:
Information provided by (Responsible Party):
Hamad Medical Corporation

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.

Condition or disease Intervention/treatment Phase
Risk Reduction Drug: Pioglitazone Plus dapaglifliozin Drug: Placebo Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 648 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Pioglitazone (15 mg) and dapagliflozin (10mg) vs Placebo
Masking: Single (Participant)
Masking Description: Random process
Primary Purpose: Health Services Research
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
Estimated Study Start Date : March 2019
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: Pioglitazone Plus dapaglifliozin
Pioglitazone 15mg and dapaglifliozin 10mg together in T2DM patients having HF and HFpEF conditions
Drug: Pioglitazone Plus dapaglifliozin
Pioglitazone Plus dapaglifliozin

Placebo Comparator: Placebo
Beta blockers, ACEI, ARB, and aldosterone
Drug: Placebo
(Beta blockers, ACEI, ARB, and aldosterone )




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Number of all cause mortality [ Time Frame: 3 years ]
    Composite outcome comprised of total mortality, incidence of acute coronary syndrome and non fatal CVA



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Diagnosis of type 2 diabetes according to the ADA criteria.
  2. Drug naïve or on stable dose of antidiabetic therapy (oral agents and/or insulin) for 3 months preceding recruitment.
  3. Hospitalized for HFpEF (defined as hospitalization require intravenous diuresis) in the 6 months preceding recruitment.
  4. eGFR >60 ml/min
  5. LVEF >50%
  6. 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).

Exclusion Criteria:

  1. Treatment with pioglitazone or SGLT2 inhibitor in the 3 months prior to recruitment.
  2. eGFR < 60 ml/min
  3. LVEF <50%;
  4. Valvular heart disease, ASD, VSD
  5. Chronic lung disease
  6. Cancer
  7. diabetes mellitus type 1
  8. patients with acute coronary syndrome, stroke or transient ischemic attack in the preceding 6 months
  9. pregnancy or lactation period

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03794518


Contacts
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Contact: Nidal Asaad, MD 44395578 nasaad@hamad.qa
Contact: Rajvir Singh, Ph.D 44390442 rsingh@hamad.qa

Locations
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Qatar
Heart Hospital, Hamad Medical Coorporation
Doha, Qatar, 3050
Sponsors and Collaborators
Hamad Medical Corporation
Investigators
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Principal Investigator: Nidal Asaad, MD Heart Hospital, HMC, Doha, Qatar

Publications of Results:

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Responsible Party: Hamad Medical Corporation
ClinicalTrials.gov Identifier: NCT03794518     History of Changes
Other Study ID Numbers: IRGC-04-SI-17-116
First Posted: January 7, 2019    Key Record Dates
Last Update Posted: January 7, 2019
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pioglitazone
2-(3-(4-ethoxybenzyl)-4-chlorophenyl)-6-hydroxymethyltetrahydro-2H-pyran-3,4,5-triol
Hypoglycemic Agents
Physiological Effects of Drugs
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action