Does dapagliflozin change heart function as detected by ultrasound in patients with heart failure?
| ISRCTN | ISRCTN95382621 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN95382621 |
- Submission date
- 09/05/2022
- Registration date
- 06/07/2022
- Last edited
- 09/05/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
Heart failure with reduced ejection fraction (HFrEF) happens when the heart muscle cannot pump forcefully enough to move the blood around the body. The effects on the heart muscle of the sodium-glucose co-transporter-2 inhibitor dapagliflozin, which is used to treat type 2 diabetes and heart failure, are not clear. Therefore, the aim of this study is to determine the effect of the addition of dapagliflozin to conventional treatment in patients with HFrEF.
Who can participate?
Patients aged 18 or over with mild to severe HFrEF.
What does the study involve?
Non-invasive imaging was used to compare the function of the heart muscle in patients with HFrEF given dapagliflozin in addition to their conventional treatment for HF for 6 months with a control group of patients with HFrEF receiving only their conventional HF treatment for the same time period.
What are the possible benefits and risks of participating?
Benefits and risks not provided at time of registration
Where is the study run from?
Omar Yacef Hospital (Algeria)
When is the study starting and how long is it expected to run for?
August 2021 to March 2022
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Professor Nassime Zaoui, nassime.zaoui@outlook.com
Contact information
Scientific
Draa Ben Khedda
Tizi Ouzou
1510
Algeria
 ORCID ID |
0000-0001-7408-5607 |
|---|---|
| Phone | +213 771815911 |
| nassime.zaoui@outlook.com |
Study information
| Study design | Observational single-center non-randomized longitudinal case-control study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case-control study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Impact of dapagliflozin on echocardiographic parameters in patients with heart failure and reduced ejection fraction |
| Study objectives | Dapagliflozin has proven its effectiveness in reducing morbi-mortality in patients with heart failure. However, its effects on systolic and diastolic echocardiographic function are less known. The objective of this study is to describe the impact of the addition of dapagliflozin to conventional treatment on echocardiographic parameters in patients with HFrEF <40% compared to a control group of patients after 6 months of treatment. |
| Ethics approval(s) | This is an observational, case-control study, which does not require ethics approval under Algerian law because the treatment is already approved in this pathology and ultrasound remains a non-invasive and mandatory examination in the usual follow-up of these patients. |
| Health condition(s) or problem(s) studied | Heart failure and reduced ejection fraction |
| Intervention | A group of patients with HFrEF<40% in stage II to IV of NYHA receiving classic HF treatment with dapagliflozin 10 mg/day were compared with a group of patients with the same profile receiving classic HF treatment only for 6 months using echocardiography at a follow-up of 7 months for ejection fraction (EF), left ventricular dysfunction (LVd), systolic pulmonary pressure (sPAP) and longitudinal strain |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Dapagliflozin |
| Primary outcome measure | 1. Heart failure functional classification assessed using NYHA stage at the first visit 2. Hospitalization rate recorded in our HF hospital registry at the end of the study 3. Ejection fraction (EF) measured by an echocardiogram (ECG) at the first visit, 3 months, and at 7 months (5-8 months) follow-up |
| Secondary outcome measures | 1. Mean left ventricular dysfunction (LVd) measured by an echocardiogram (ECG) at the first visit, 3 months, and at 7 months (5-8 months) follow-up 2. Systolic pulmonary pressure (sPAP) measured by an ECG at the first visit, 3 months, and at 7 months (5-8 months) follow-up 3. Mean longitudinal Strain measured by ECG at the first visit, 3 months, and at 7 months (5-8 months) follow-up 4. Urinary tract infection assessed by interrogation (presence of burning urination) and urine strip (Labstix) at each consultation (at the first visit, 3 months, and at 7 months (5-8 months) follow-up) and if necessary cytobacteriological urine examination (in the case of burning urination) |
| Overall study start date | 01/08/2021 |
| Completion date | 31/03/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 50 |
| Total final enrolment | 43 |
| Key inclusion criteria | Patients with HFrEF<40% in NYHA stage II to IV, who presented to our department during the recruitment period |
| Key exclusion criteria | Type 1 diabetes |
| Date of first enrolment | 15/08/2021 |
| Date of final enrolment | 30/11/2021 |
Locations
Countries of recruitment
- Algeria
Study participating centre
Tizi Ouzou
1510
Algeria
Sponsor information
University/education
Tizi Ouzou
Tizi Ouzou
15000
Algeria
| Phone | +213 26217381 |
|---|---|
| decanat.fm@ummto.dz | |
| Website | http://www.ummto.dz |
"ROR" |
https://ror.org/050ktqq97 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 30/05/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Published as a supplement to the results publication |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated and/or analysed during the current study will be published as a supplement to the results publication |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/10/2022 | 09/05/2023 | Yes | No |
Editorial Notes
09/05/2023: Publication reference added.
20/04/2023: The scientific contact's email address has been changed.
17/05/2022: Trial’s existence confirmed by the ethics committee of Omar Yacef Hospital.
