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
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|Condition or disease||Intervention/treatment||Phase|
|Aortic Stenosis Transcatether Aortic Valve Implantation||Drug: Dapagliflozin 10 MG||Phase 4|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1020 participants|
|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:
|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)|
|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|
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
- 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).
- Incidence rate all-cause mortality [ Time Frame: 1 year ]All cause mortality
- Incidence rate of Cardiovascular death [ Time Frame: 1 year ]Mortality secondary to cardiovascular cause
- 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).
- Incidence rate of atrial fibrillation [ Time Frame: 1 year ]Atrial Fibrillation confirmed by ECG
- Improvement in NYHA class. [ Time Frame: 1 year ]Functional class according to New York Heart Association classification
- 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.
- Genital or Urinary Infections
- Necrotizing Fasciitis of the Perineum (Fournier's Gangrene)
- 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
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- SEVERE AORTIC STENOSIS UNDERWENT TAVI
PRIOR HEART FAILURE ADMISSION AND ONE OF THE FOLLOWING CRITERIA:
- Left ventricular ejection fraction ≤ 40% or
- Diabetes mellitus or
- Estimated glomerular filtrate rate 25-75 ml/min/1.73 m2
- 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.
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
|Contact: SERGIO RAPOSEIRAS ROUBIN, PhD, MD||034 firstname.lastname@example.org|
|Contact: IGNACIO AMAT SANTOS, PhD, MD||034 email@example.com|
|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|
Documents provided by SERGIO RAPOSEIRAS ROUBIN, Spanish Society of Cardiology:
|Responsible Party:||SERGIO RAPOSEIRAS ROUBIN, Principal Investigator, Spanish Society of Cardiology|
|Other Study ID Numbers:||
|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|
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
|Time Frame:||5 years|
|Access Criteria:||Email (firstname.lastname@example.org)|
|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|
Aortic Valve Stenosis
Aortic Valve Disease
Heart Valve Diseases
Ventricular Outflow Obstruction
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs