Dapagliflozin After Transcatheter Aortic Valve Implantation (DapaTAVI)

January 8, 2025 updated by: SERGIO RAPOSEIRAS ROUBIN, Spanish Society of Cardiology
Pragmatic, controlled, prospective, randomized, open-label (open-label), evaluator-blind clinical trial (PROBE design) that will analyze the benefits of dapagliflozin treatment in patients with severe aortic stenosis discharged after implantation of an aortic valve prosthesis transcatheter (TAVI).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Patients discharged after TAVI, with a history of heart failure (HF) plus depressed left ventricular ejection fraction (LVEF ≤ 40%) or diabetes mellitus (DM) or glomerular filtration rate (GFR) between 25 and 75 ml/min/1.73 m2, will be randomized (1:1) before hospital discharge to receive treatment with dapagliflozin 10 mg/day or no dapagliflozin (no placebo).

Only variables available during routine clinical practice will be collected and there will be no additional tests.

The incidence of clinical events and adherence to the dapagliflozin arm will be documented at 2 time-points (3 ± 1 months and 12 months) by phone calls and review of medical records.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1257

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: IGNACIO AMAT SANTOS, PhD, MD
  • Phone Number: 034 657923040
  • Email: ijamat@gmail.com

Study Locations

  • Spain
      • Albacete, Spain
        • Hospital Universitario de Albacete
      • Alicante, Spain
        • Hospital General Universitario de Alicante
      • Barakaldo, Spain
        • Hospital Universitario de Cruces
      • Barcelona, Spain
        • Hospital Universitario Vall d´Hebrón
      • Barcelona, Spain
        • Hospital De Bellvitge
      • Barcelona, Spain
        • Hospital Clinic
      • Barcelona, Spain
        • Centro Médico Teknon
      • Barcelona, Spain
        • Hospital Universitario Sant Pau
      • Barcelona, Spain
        • Hospital German I Trias
      • Cadiz, Spain
        • Hospital Puerta del Mar
      • Cordoba, Spain
        • Hospital Reina Sofia
      • Coruña, Spain
        • Hospital Juan Canalejo
      • Granada, Spain
        • Hospital San Cecilio
      • Granada, Spain
        • Hospital Virgen de las Nieves
      • Huelva, Spain
        • Hospital Juan Ramón Jimenez
      • Jaen, Spain
        • Hospital Universitario de Jaen
      • León, Spain
        • Hospital Universitario de Leon
      • Madrid, Spain
        • Hospital Ramon y Cajal
      • Madrid, Spain
        • Hospital 12 De Octubre
      • Madrid, Spain
        • Fundación Jiménez Díaz
      • Madrid, Spain
        • Hospital Clinico San Carlos
      • Madrid, Spain
        • Hospital La Princesa
      • Madrid, Spain
        • Hospital Puerta de Hierro
      • Madrid, Spain
        • Clinica La Luz
      • Madrid, Spain
        • Clinica Nuestra Señora de América de Madrid
      • Madrid, Spain
        • Hospital Universitario De Torrejon
      • Málaga, Spain
        • Hospital Virgen de la Victoria
      • Oviedo, Spain
        • Hospital Universitario Central de Asturias
      • Palma De Mallorca, Spain
        • Hospital Son Espases
      • Pamplona, Spain
        • Hospital Universitario de Navarra
      • Salamanca, Spain
        • Hospital Universitario de Salamanca
      • Santander, Spain
        • Hospital Marqués de Valdecilla
      • Santiago De Compostela, Spain
        • Hospital Clínico de Santiago
      • Sevilla, Spain
        • Hospital Virgen del Rocío
      • Tenerife, Spain
        • Hospital Universitario de Canarias
      • Valencia, Spain
        • Hospital Clinico de Valencia
      • Valencia, Spain
        • Hospital La Fe
      • Valladolid, Spain
        • Hospital Clínico Universitario de Valladolid
      • Vigo, Spain
        • Hospital Alvaro Cunqueiro
      • Zaragoza, Spain
        • Hospital Miguel Servet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • SEVERE AORTIC STENOSIS UNDERWENT TAVI

  • PRIOR HEART FAILURE ADMISSION AND ONE OF THE FOLLOWING CRITERIA:

    1. Left ventricular ejection fraction ≤ 40% or
    2. Diabetes mellitus or
    3. Estimated glomerular filtrate rate 25-75 ml/min/1.73 m2

Exclusion Criteria:

  • Known allergy or intolerance to SGLT2 inhibitors.
  • Concomitant therapy with sulfonylurea or SGLT2 inhibitors..
  • Systolic blood pressure < 100 mmHg or diastolic blood pressure < 50 mmHg.
  • An estimated glomerular filtration rate (GFR) below 25 ml per minute per 1.73 m2.
  • Chronic cystitis and/or recurrent urinary tract infections (2 or more in the last year)
  • Poor control of diabetes mellitus that requires SGLT-2 inhibitor prescription on discharge according to treating physician judge.
  • Any medical condition that, in the investigator´s judgment, would seriously limit life expectancy (less than one year).
  • Pregnant or breast-feeding patients
  • Patients participating in other clinical trials.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Dapagliflozin
Sodium-glucose cotransporter-2 (SGLT-2) inhibitor therapy with daily oral dose of dapagliflozin 10 mg
Drug: Dapagliflozin 10 MG
Dapagliflozin 10 mg (daily oral dose)
No Intervention: Standard care
No SGLT-2 inhibitor therapy with dapagliflozin

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence rate of the composite of all-cause mortality or worsening heart failure (HF)
Time Frame: 1 year
All-cause mortality and worsening HF (including hospitalization for HF or an urgent visit resulting in intravenous therapy for HF).
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence rate all-cause mortality
Time Frame: 1 year
All cause mortality
1 year
Incidence rate of Cardiovascular death
Time Frame: 1 year
Mortality secondary to cardiovascular cause
1 year
Incidence rate of Hospitalization for Heart Failure
Time Frame: 1 year
Heart Failure requiring hospital admission
1 year
Incidence rate of Urgent Heart Failure visits
Time Frame: 1 year
Urgent Heart Failure visit requiring intravenous therapy
1 year
Incidence rate of the composite of Heart Failure hospitalization or Cardiovascular death
Time Frame: 1 year
Composite of Heart Failure hospitalization or Cardiovascular death
1 year
Total number of Heart Failure hospitalizations and Cardiovascular deaths
Time Frame: 1 year
Total number of (first and recurrent) Heart Failure hospitalizations and Cardiovascular deaths
1 year

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Improvement in NYHA class.
Time Frame: 1 year
Functional class according to New York Heart Association classification
1 year
Rate of treatment switch (crossovers)
Time Frame: 1 year
Percentage of patients in the "dapagliflozin arm" who stop this treatment and percentage of patients in "standard care" arm who start dapagliflozin therapy
1 year
Incidence of new Atrial Fibrillation
Time Frame: 1 year
Diagnosis of new Atrial Fibrillation in patients without history of atrial fibrillation at baseline
1 year
Safety endpoints
Time Frame: 1 year
  1. Symptomatic hypotension. Symptomatic hypotension includes postural dizziness with systolic blood pressure < 100 mmHg, and orthostatic hypotension (defined as a decrease of >20 mmHg in systolic blood pressure or >10 mmHg in diastolic blood pressure from a supine to a standing position).
  2. Major hypoglycemia. Major hypoglucemia is defined as an event where all the following criteria were confirmed by the investigator: (1) the patient experienced symptoms of severe impairment in consciousness or behaviour; (2) the patient needed external assistance; (3) intervention was needed to treat the hypoglycaemia; and (4) there was prompt recovery of acute symptoms following the intervention.
  3. Ketoacidosis.
  4. Genital or Urinary Infections
  5. Amputation
  6. Necrotizing Fasciitis of the Perineum (Fournier's Gangrene)
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Spanish Society of Cardiology

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: EMAD ABU ASSI, PhD, MD, University Hospital Alvaro Cunqueiro, Vigo, Spain
  • Study Director: BORJA IBAÑEZ, PhD, MD, Centro Nacional de Investigaciones Cardiovasculares (CNIC, Madrid, Spain)
  • Principal Investigator: SERGIO RAPOSEIRAS ROUBIN, PhD, MD, University Hospital Alvaro Cunqueiro, Vigo, Spain
  • Principal Investigator: IGANCIO AMAT SANTOS, PhD, MD, Hospital Clínico Universitario de Valladolid

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 27, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 29, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 30, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 3, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 6, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 8, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SEC-DAPATAVI-2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All data will be available to other researchers after ending the trial, prior to a formal request to the Executive Committee

IPD Sharing Time Frame

5 years

IPD Sharing Access Criteria

Email (dapatavi@gmail.com)

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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