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Heart FailurePhase 3MODANCT04707352

Impact on Atrial Remodeling of Dapaglifozin in Patients With Heart Failure .

A Phase 3 study testing Dapagliflozin in people with Heart Failure, run by Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Dapagliflozin reduces the risk of de novo heart failure (HF) in diabetics and, recently, it has shown to improve the prognosis of patients with HF and reduced left ventricular ejection fraction (HFrEF), by preventing HF decompensations and cardiovascular death. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Failure
What is being tested?
Dapagliflozin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
162 participants
Where
1 siteSpain
Study dates
8 Feb 2021to 26 Mar 2023
Phase
Phase 3
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 > 18 years
  • Prior diagnosis of HF, with at least one hospitalization for HF at any time.
  • NYHA class I-IV.
  • LVEF available (echocardiogram or cardiac MRI) within the last 12 months prior to enrolment.
  • Treatment according with contemporary guidelines recommendations and with stable doses of oral loop diuretics for at least 4 weeks
  • NT-proBNP >600 pg/ml at screening (≥400 pg/ml if hospitalized for HF within the previous 12 months; ≥900 pg/ml If concomitant AF at
  • Screening irrespective of time to last HF hospitalization).

Who cannot join

  • Dapagliflozin or other SGLT2i at any time in prior 6 months.
  • Type 1 diabetes mellitus (T1D)
  • Estimated glomerular filtration rate < 30 ml/min/1.73 m2 as measured by the simplified Modification of Diet in Renal Disease (MDRD) formula at screening.
  • Symptomatic hypotension or systolic blood pressure (SBP) <95 mmHg on 2 consecutive measurements at screening.
  • Uncontrolled hypertension, defined as SBP >160 mmHg.
  • Current acute decompensated HF or hospitalization due to decompensated HF within 4 weeks prior to enrolment
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  • The use of outpatient or inpatient i.v. diuretic therapy within 4 weeks prior to baseline.
  • Subjects who are currently receiving or have received inotropic agents within 12 weeks prior to baseline.
  • Myocardial infarction, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment
  • Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting or valvular repair/replacement within 12 weeks prior to enrolment or planned to undergo any of these operations after inclusion
  • Implantation of a cardiac resynchronization therapy (CRT) within 12 weeks prior to enrolment or intent to implant a CRT device
  • Previous cardiac transplantation or implantation of a ventricular assistance device (VAD) or similar device, or implantation expected after inclusion
  • HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease
  • Symptomatic bradycardia or second or third degree heart block without a pacemaker
  • History of allergic reactions or intolerance to dapagliflozin, or other iSGLT2, or any other compound
  • History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within one year.
  • Hepatic impairment aspartate transaminase [AST] or alanine transaminase [ALT] >3x the upper limit of normal [ULN]; or total bilirubin >2x ULN at time of screening)
  • Women of child-bearing potential (ie, those who are not chemically or surgically sterilised or who are not post-menopausal) who are not willing to use a medically accepted method of contraception that is considered reliable in the judgment of the investigator or women who have a positive pregnancy test at enrollment or randomization or women who are breast-feeding
  • Participation in another clinical trial during the last month prior to enrolment
  • Inability of the patient, in the opinion of the investigator, to understand and/or comply with study medications, procedures and/or follow-up or any conditions that, in the opinion of the investigator, may render the patient unable to complete the study
  • Any concomitant disease limiting life expectancy in the following year (other than heart failure)
  • No possibility to give informed consent.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Hospital Clinico Universitario Virgen de la Arrixaca

    Murcia, 30003

Other trials in Spain

About this study

Dapagliflozin reduces the risk of de novo heart failure (HF) in diabetics and, recently, it has shown to improve the prognosis of patients with HF and reduced left ventricular ejection fraction (HFrEF), by preventing HF decompensations and cardiovascular death. The benefit showed by dapagliflozin in HFrEF was irrespective of diabetes status and glycemic control, which raises the question of which mechanisms are underlying apart from SGLT2 inhibition. In addition, the impact of dapagliflozin on cardiac remodeling parameters, as assessed by echocardiography and biomarkers, is not well established. In particular, left atrial (LA) remodeling represents a relevant prognostic marker, which has received a greater attention in the last years in the context of new imaging tools.

The purpose of this study is to assess the effect of dapagliflozin therapy over a period of 6 months in LA remodeling parameters, including geometry and function, as well as complementary biomarkers in patients with chronic HF regardless left ventricular ejection fraction (LVEF). This protocol will allow for evaluation of improved understanding of the interplay between dapagliflozin and LA function , biomarkers, remodeling and outcomes, and will carefully assess such relationships within important cohorts of subjects, such as those with reduced and preserved LVEF.

This protocol will also generate a biorepository of well-handled and carefully considered biomarkers, which will allow a better understanding of dapagliflozin mechanism of action.

Read the detailed description

The reduction of death and HF related events observed with dapagliflozin make necessary to clarify the mechanisms underlying these clinical benefits. Currently, dapagliflozin is indicated in patients with diabetes irrespective of the presence of HF. The initiation in patients with HF represents an opportunity to elucidate the effect of dapagliflozin on cardiac remodeling in this population. Therefore, we propose a study that aims to assess the effects of dapagliflozin in echocardiographic parameters of cardiac remodeling, with special interest in LA geometry and function, as well as in biomarkers reflecting expanded pathophysiological pathways. LA volume has shown to identify the progression of HF irrespective of LVEF and, therefore, it represents a meaningful measure of the cardiac impact of dapagliflozin in the entire spectrum of chronic HF.

Conditions
Heart Failure
Being tested
Dapagliflozin
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DapagliflozinDrug

    All eligible subjects will receive Dapagliflozin 10 mg each day. The study treatment will be provided for the duration of the trial from baseline (Day 1) through last visit (Day 180).

Study groups in NCT04707352
Study groupRoleWhat they receive
DapagliflozinExperimentalThe baseline procedures will be performed on the same day of screening or within the next five working days. All the baseline procedures will be performed on the same day. The baseline procedures include biobank, clinical assessment and echocardiogram, on the same day. In the following 24 hours, the patient will initiate Dapagliflozin at the recommended dose of 10 mg daily during 6 months. Temporary discontinuation may be considered at investigator criteria as in cases of symptomatic hypotension or acute declines in renal function and after discarding other potential causes.
Receives: Drug: Dapagliflozin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in LAVI from baseline to 6 months.

    Measured: Up to 6 months

Secondary outcomes (8)

  1. Change in LAVI-min (minimal left atrial volume index)

    Measured: Up to 6 months

  2. Change in LAEF (left atrial ejection)

    Measured: Up to 6 months

  3. Change in LAFI (left atrial functional index)

    Measured: Up to 6 months

  4. Change in LA reservoir, conduit and pump volumes, emptying fractions and strain rates

    Measured: Up to 6 months

  5. Change in Left ventricular end-systolic volume index (LVESVi)

    Measured: Up to 6 months

  6. Change in left ventricular mass index (LVMI) Change in ventricular end-diastolic volume index (LVEDVi)

    Measured: Up to 6 months

  7. Change in global longitudinal strain (GLS)

    Measured: Up to 6 months

  8. Change in tricuspid annular plane systolic

    Measured: Up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jan 2021
  2. Study start8 Feb 2021
  3. Primary completion26 Mar 2023
  4. Study completion26 Mar 2023

Resources

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 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Interventional, open-label and single-arm
Masking
None (open label)
Enrolment
162 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04707352
Sponsor's protocol ID
ESR-20-20594 - MODA study
Acronym
MODA
Status last verified
Feb 2023
First submitted
11 Jan 2021
Last updated
12 Jul 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Pascual-Figal DA, Zamorano JL, Domingo M, Morillas H, Nunez J, Cobo Marcos M, Riquelme-Perez A, Teis A, Santas E, Caro-Martinez C, Pinilla JM, Rodriguez-Palomares JF, Dobarro D, Restrepo-Cordoba MA, Gonzalez-Juanatey JR, Bayes Genis A; DAPA-MODA Study Investigators. Impact of dapagliflozin on cardiac remodelling in patients with chronic heart failure: The DAPA-MODA study. Eur J Heart Fail. 2023 Aug;25(8):1352-1360. doi: 10.1002/ejhf.2884. Epub 2023 Jun 7.

    PubMed 37211950

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dapagliflozin in people with Heart Failure, run by Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia at 1 site in Spain.

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 7 inclusion and 22 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: finished, as of the sponsor's last update on 12 Jul 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 Spain. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in LAVI from baseline to 6 months. (time frame: Up to 6 months). 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 NCT04707352, 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 12 Jul 2023.

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