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Trial record 1 of 1 for:    dapatavi
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Dapagliflozin After Transcatheter Aortic Valve Implantation (DapaTAVI)

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ClinicalTrials.gov Identifier: NCT04696185
Recruitment Status : Recruiting
First Posted : January 6, 2021
Last Update Posted : November 18, 2022
Sponsor:
Collaborator:
Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III
Information provided by (Responsible Party):
SERGIO RAPOSEIRAS ROUBIN, Spanish Society of Cardiology

Study Description
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Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Aortic Stenosis Transcatether Aortic Valve Implantation Drug: Dapagliflozin 10 MG Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1020 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Dapa-TAVI is a pragmatic, controlled, prospective, randomized, open-label blinded endpoint (PROBE design) clinical trial. Patients being discharged after TAVI who meet all inclusion criteria, and none of the exclusion criteria, will be eligible for the enrollment. Patients will be 1:1 randomized to 1 of these 2 arms:

  • Intervention group: Sodium-glucose cotransporter-2 (SGLT-2) inhibitor therapy with daily oral dose of dapagliflozin 10 mg.
  • Control group: no SGLT-2 inhibitor therapy with dapagliflozin.
Masking: Single (Outcomes Assessor)
Masking Description: All events will be adjudicated by the Clinical Events Adjudication Committee (CEAC), without information about the therapy (intervention or control) (blinded endpoint)
Primary Purpose: Treatment
Official Title: Dapagliflozin After Transcatheter Aortic Valve Implantation
Actual Study Start Date : January 27, 2021
Estimated Primary Completion Date : March 31, 2023
Estimated Study Completion Date : March 31, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. Incidence rate all-cause mortality [ Time Frame: 1 year ]
    All cause mortality

  2. Incidence rate of Cardiovascular death [ Time Frame: 1 year ]
    Mortality secondary to cardiovascular cause

  3. Incidence rate of worsening heart failure (HF) [ Time Frame: 1 year ]
    Worsening HF (including hospitalization for HF or an urgent visit resulting in intravenous therapy for HF).

  4. Incidence rate of atrial fibrillation [ Time Frame: 1 year ]
    Atrial Fibrillation confirmed by ECG


Other Outcome Measures:
  1. Improvement in NYHA class. [ Time Frame: 1 year ]
    Functional class according to New York Heart Association classification

  2. Safety endpoints [ Time Frame: 1 year ]
    • 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).
    • 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.
    • Ketoacidosis.
    • Genital or Urinary Infections
    • Amputation
    • Necrotizing Fasciitis of the Perineum (Fournier's Gangrene)

  3. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04696185


Contacts
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Contact: SERGIO RAPOSEIRAS ROUBIN, PhD, MD 034 620170387 raposeiras26@hotmail.com
Contact: IGNACIO AMAT SANTOS, PhD, MD 034 657923040 ijamat@gmail.com

Locations
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Sponsors and Collaborators
Spanish Society of Cardiology
Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III
Investigators
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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
  Study Documents (Full-Text)

Documents provided by SERGIO RAPOSEIRAS ROUBIN, Spanish Society of Cardiology:
Study Protocol and Statistical Analysis Plan  [PDF] October 14, 2020
Informed Consent Form  [PDF] October 14, 2020

More Information
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Additional Information:

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Responsible Party: SERGIO RAPOSEIRAS ROUBIN, Principal Investigator, Spanish Society of Cardiology
ClinicalTrials.gov Identifier: NCT04696185    
Other Study ID Numbers: SEC-DAPATAVI-2020
First Posted: January 6, 2021    Key Record Dates
Last Update Posted: November 18, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All data will be available to other researchers after ending the trial, prior to a formal request to the Executive Committee
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: 5 years
Access Criteria: Email (dapatavi@gmail.com)
URL: https://www.dapatavi.com/

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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
Keywords provided by SERGIO RAPOSEIRAS ROUBIN, Spanish Society of Cardiology:
Aortic Stenosis
TAVI
Dapagliflozin
Additional relevant MeSH terms:
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Aortic Valve Stenosis
Aortic Valve Disease
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction
 Dapagliflozin
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs