Dapagliflozin Adverse ReactionPhase 4DAPA-SERVENCT05717257
Dapagliflozin in Systemic Right Ventricle (DAPA-SERVE)
A Phase 4 study testing Dapagliflozin 10mg Tab in people with Dapagliflozin Adverse Reaction and Efficacy, run by Monaldi Hospital at 1 site in Italy.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dapagliflozin Adverse Reaction, Efficacy, Systemic Right Ventricle
- What is being tested?
- Dapagliflozin 10mg Tab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 1 Aug 2022to Aug 2024
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age≥18years
- Optimal medical therapy or at least 3months
- Systemic right ventricle ejection fraction≤40%, assessed on echocardiography
Who cannot join
- Univentricular physiology
- Systolic blood pressure<90mmHg
- Glomerular filtration rate(GFR)<30ml/min
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Adult Congenital Heart Disease, Monaldi Hospital
Naples, 80121
Flavia Fusco, MD, 00390817064206, flavia.fusco@ospedalideicolli.it
About this study
Official title: Safety and Efficacy of Dapagliflozin in Adult Patients With a Systemic Right Ventricle
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.
Read the detailed description
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.
- Being tested
- Dapagliflozin 10mg Tab
- Keywords
- heart failure, dapagliflozin, systemic right ventricle
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dapagliflozin 10mg TabDrug
Dapagliflozin 10 mg will be added on top of the standard optimized medical therapy for heart failure and reduced ejection fraction
| Study group | Role | What they receive |
|---|---|---|
| Dapagliflozin | Experimental | Dapagliflozin will be added on top of the standard optimized medical therapy for heart failure and reduced ejection fraction Receives: Drug: Dapagliflozin 10mg Tab |
| Control | No intervention | Participants assigned to this group will continue the standard optimized medical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Absence of any suspected or confirmed adverse events or necessity of drug discontinuation
Measured: 1 year
Nt-proBNP
Measured: 1 year
Systemic right ventricle fractional area change
Measured: 1 year
Systemic right ventricle global longitudinal strain
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start1 Aug 2022
- Primary completionAug 2023 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dapagliflozin Adverse ReactionStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to the treatment or control group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Monaldi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Flavia Fusco, Monaldi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05717257
- Sponsor's protocol ID
- 001
- Acronym
- DAPA-SERVE
- Status last verified
- Jan 2023
- First submitted
- 29 Jan 2023
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Fusco F, Scognamiglio G, Abbate M, Merola A, Grimaldi N, Ciriello GD, Sarubbi B. Dapagliflozin in Patients With a Failing Systemic Right Ventricle: Results From the DAPA-SERVE Trial. JACC Heart Fail. 2024 Apr;12(4):789-791. doi: 10.1016/j.jchf.2024.01.006. Epub 2024 Feb 28. No abstract available.
PubMed 38430085
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Dapagliflozin in Adult Patients With a Systemic Right Ventricle
- ClinicalTrials.gov ID
- NCT05717257
- Acronym / sponsor ID
- DAPA-SERVE / 001
- Keywords
- heart failure, dapagliflozin, systemic right ventricle
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Monaldi HospitalUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 8 Feb 2023 (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 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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to the treatment or control group
| Arm | Type | Receives |
|---|---|---|
| Dapagliflozin | Experimental | Drug: Dapagliflozin 10mg TabDapagliflozin will be added on top of the standard optimized medical therapy for heart failure and reduced ejection fraction |
| Control | No intervention | –Participants assigned to this group will continue the standard optimized medical therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age≥18years
- Optimal medical therapy or at least 3months
- Systemic right ventricle ejection fraction≤40%, assessed on echocardiography
Key exclusion criteria (3 listed)
- Univentricular physiology
- Systolic blood pressure<90mmHg
- Glomerular filtration rate(GFR)<30ml/min
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 |
|---|---|---|
| Dapagliflozin 10mg TabDapagliflozin 10 mg will be added on top of the standard optimized medical therapy for heart failure and reduced ejection fraction | Drug | Dapagliflozin |
Primary outcome
Adverse Events
Time frame: 1 year
Absence of any suspected or confirmed adverse events or necessity of drug discontinuation
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Derived from this study: PubMed 38430085Fusco F, Scognamiglio G, Abbate M, Merola A, Grimaldi N, Ciriello GD, Sarubbi B. Dapagliflozin in Patients With a Failing Systemic Right Ventricle: Results From the DAPA-SERVE Trial. JACC Heart Fail. 2024 Apr;12(4):789-791. doi: 10.1016/j.jchf.2024.01.006. Epub 2024 Feb 28. No abstract available.
- Individual participant dataSharing planned: Undecided
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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.
Adult Congenital Heart Disease, Monaldi Hospital
Naples, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dapagliflozin 10mg Tab in people with Dapagliflozin Adverse Reaction and Efficacy, run by Monaldi Hospital at 1 site in Italy.
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 3 inclusion and 3 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 8 Feb 2023. 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 Italy. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (time frame: 1 year). The study lists 4 primary outcomes in all. 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 NCT05717257, which also lists 1 linked publication.
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 8 Feb 2023.