A Phase 4 interventional study of Dapagliflozin 10mg Tab in Dapagliflozin Adverse Reaction, Efficacy and Systemic Right Ventricle, sponsored by Monaldi Hospital. Status unknown at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-08.
Sponsored by Monaldi Hospital · Phase 4, Interventional, and Treatment
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Among 59 studies testing dapagliflozin in Heart Failure — 15 open to participants now, 19 under way, 6 of them phase 3. dapagliflozin · Heart Failure.
Among the 59 studies testing dapagliflozin in Heart Failure, this one is the 44th largest by planned enrollment, is one of 11 that started in 2022, is one of 22 in phase 4, and was the 36th registered.
6,332 studies on the registry are indexed under Heart Failure; 1,392 are open to participants now.
Browse Heart Failure studies →15 of the 59 studies testing dapagliflozin in Heart Failure are open now, in 12 countries. Recruiting first, the newest first:
The University of Hong Kong · Sites in Hong Kong
Ages 12+
Yale University · Sites in United States
Ages 18–85 · Healthy volunteers
Assistance Publique - Hôpitaux de Paris · Sites in France
Ages 18+
Mayo Clinic · Sites in United States
Ages 18+
AstraZeneca · Sites in United States, Argentina, Australia and 32 more countries
Ages 40+
By country, each count listing its studies:
dapagliflozin: first FDA approval 2014 (FARXIGA), first EMA approval 2012. What it is approved for, and how studies give it, is on its page →
Of the 966 Heart Failure studies recruiting now, 689 (71%) set no upper age limit and 89 (9%) stop at 75 or younger; 63 take children under 18; 96 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
59 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 14 · Phase 3 20 · Phase 4 22
First in 2015; this study’s year is marked. 11 started in 2022.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 50 is below the median of 76 across 4,049 interventional studies indexed under Heart Failure.
Median enrollment 100 across the 59 interventional studies. Of the 30 that completed or were terminated, 12 (40%) have results posted.
This tab as a report to print or save as PDF → With an account.
7 of 59 have an industry lead sponsor. The 10 most frequent:
Monaldi Hospital is the lead sponsor of 7 studies on the registry; 1 is open to participants now.
Monaldi Hospital has 3 studies filed under Heart Failure — fewer than ten, so there is no comparison to draw.
4 of the studies testing dapagliflozin in Heart Failure that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06304857Phase 34th Military Clinical Hospital with Polyclinic, PolandCardioPROTECTion with Dapagliflozin in Breast Cancer Patients Treated with AnthrAcycline - PROTECTAA TRIAL | 2026-12-31 |
| NCT05374291Phase 3University Medical Center GroningenThe RENAL LIFECYCLE Trial: A RCT to Assess the Effect of Dapagliflozin on Renal and Cardiovascular Outcomes in Patients With Severe CKD | 2027-07 |
| NCT06578520Fundación para la Investigación del Hospital Clínico de ValenciaEffect of the Use of Dapagliflozin in Patients With Refractory Heart Failure | 2026-12-01 |
| NCT06762964Mayo ClinicCAMEO-FONTAN -Dapagliflozin in the Failing Fontan Circulation | 2027-02 |
Add all 4 to your calendar (.ics) → With an account.
Among the 59 studies testing dapagliflozin in Heart Failure, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The purpose of this study is to describe safety and efficacy of Dapaglifozin in adults patients with a systemic right ventricle (congenitally corrected transposition of the great arteries or transposition of the great arteries following arterial switch procedure) and impaired systolic function of the systemic right ventricle.
This is a prospective double arm study aiming to describe safety and efficacy of Dapaglifozin in adults patients with a systemic right ventricle (congenitally corrected transposition of the great arteries or transposition of the great arteries following arterial switch procedure) and impaired systolic function of the systemic right ventricle.
Dapagliflozin will be prescribed in a group of randomly selected patients in addition to the optimized medical therapy for heart failure with reduced ejection fraction.
Changes in quality of life indicators, symptoms, biohumoral markers, exercise capacity and echocardiographic parameters of systolic right ventricular function will be evaluated in comparison with the control group, which will continue standard heart failure therapy.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Dapagliflozin will be added on top of the standard optimized medical therapy for heart failure and reduced ejection fraction
Drug: Dapagliflozin 10mg Tab
Participants assigned to this group will continue the standard optimized medical therapy
Dapagliflozin 10 mg will be added on top of the standard optimized medical therapy for heart failure and reduced ejection fraction
Adverse Events
Absence of any suspected or confirmed adverse events or necessity of drug discontinuation
Time frame: 1 year
Nt-proBNP
Time frame: 1 year
Systemic right ventricle fractional area change
Time frame: 1 year
Systemic right ventricle global longitudinal strain
Time frame: 1 year
Plan to share: Undecided
No publications or documents are linked to this record.
Started Aug 2022 (actual). Primary completion is estimated for Aug 2023, 12 months after the start.
Of 164 non-industry phase 4 interventional studies under Heart Failure, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 56. This study's planned 12 months is below that.
Counting every sponsor, half of 183 studies reached it within 31 months; a quarter within 22 and three quarters within 56.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Dapagliflozin
Monaldi Hospital