Status:
UNKNOWN
Cardiometabolic Effects of Dapagliflozin in Heart Failure With Reduced or Mildly Reduced Ejection Fraction
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Heart Failure
Reduced Ejection Fraction
Eligibility:
All Genders
18-100 years
Phase:
PHASE2
Brief Summary
Gliflozins have demonstrated a beneficial effect in terms of incident heart failure and related events in patients with or without diabetes. The clinical trial ICARD is an exploratory study that aims ...
Detailed Description
Open-label, non-controlled clinical trial (Jardé 1) to assess the cardiovascular and metabolic effects of once-daily dapagliflozin 10 mg during 6 months in patients with heart failure and reduced ejec...
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- NYHA functional class II-IV.
- Previous hospitalization for heart failure anytime or NT-proBNP \>125 pg/ml in the previous 12 months
- Left ventricular ejection fraction ≤ 50% measured at least 1 time in transthoracic echocardiography in the last 12 months
- Treated by optimal medical therapy (ACE-I or angiotensin receptor blocker or sacubitril-valsartan, and betablockers, and mineralocorticoid receptor antagonist and furosemide) unless such use was contraindicated or previously associated with side-effects leading to drug discontinuation. No change in drugs dosages in the last month.
- Able to give written informed consent
- If female of childbearing potential, have a negative serum pregnancy test
- Use of a validated method of birth control until the end of the study (men and women)
- Affiliation to a social security regime
Exclusion
- Hypersensitivity to dapagliflozin or to any of the excipients
- Current treatment with gliflozine
- Cardiac rhythm disorder including atrial fibrillation \> 100 bpm
- Significant valvular heart disease including mitral or aortic regurgitation \> II/IV
- Hospitalisation for heart failure or unplanned visit for worsening heart failure in the last month
- Recent (last 3 months) or planned coronary revascularization
- Acute coronary syndrome, stroke, or transient ischemic attack in the last 3 months
- Body mass-index \> 40 kg/m2
- Uncontrolled type 2 diabetes (Hb1AC \> 9%) or type 1 diabetes
- Genetic diabetes (Maturity Onset Diabetes of the Young, MODY)
- Current treatment for cancer, cardiotoxic cancer treatment in the last year
- Treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones in the last 6 weeks
- Active infectious diseases
- Hypovolemia or dehydration, severe hypokalaemia, or severe hyponatremia
- Contraindication to MRI or to contrast agents used
- Estimated glomerular filtration rate (eGFR) \< 30 ml per minute per 1.73 m2 of body-surface area (according to the Modification of Diet in Renal Disease criteria)
- Patient on AME (state medical aid)
- Pregnant or breast-feeding female
- Current participation in another interventional study or being in the exclusion period at the end of a previous study
- Patient protected by law (guardianship, tutelage measure, deprived of liberty)
Key Trial Info
Start Date :
June 26 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05420285
Start Date
June 26 2022
End Date
May 1 2024
Last Update
December 9 2022
Active Locations (1)
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1
Pitié-Salpêtrière Hospital
Paris, France, 75013