Dapagliflozin After Transcatheter Aortic Valve Implantation

Aortic Stenosis Clinical Trial

— DapaTAVI  

Official title:

Dapagliflozin After Transcatheter Aortic Valve Implantation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04696185
• Other study ID #: SEC-DAPATAVI-2020
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: January 27, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: Spanish Society of Cardiology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1020
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aortic Stenosis
• Aortic Valve Stenosis
• Transcatether Aortic Valve Implantation

Intervention

Drug:
• Dapagliflozin 10 MG
Dapagliflozin 10 mg (daily oral dose)

Locations

Country	Name	City	State
Spain	Hospital Universitario de Albacete	Albacete
Spain	Hospital General Universitario de Alicante	Alicante
Spain	Hospital Universitario de Cruces	Barakaldo
Spain	Centro Médico TEKNON	Barcelona
Spain	Hospital Clinic	Barcelona
Spain	Hospital de Bellvitge	Barcelona
Spain	Hospital German I Trias	Barcelona
Spain	Hospital Universitario Sant Pau	Barcelona
Spain	Hospital Universitario Vall D´Hebron	Barcelona
Spain	Hospital Puerta Del Mar	Cadiz
Spain	Hospital Reina Sofia	Cordoba
Spain	Hospital Juan Canalejo	Coruña
Spain	Hospital San Cecilio	Granada
Spain	Hospital Virgen de Las Nieves	Granada
Spain	Hospital Juan Ramón Jiménez	Huelva
Spain	Hospital Universitario de Jaen	Jaen
Spain	Hospital Universitario de León	León
Spain	Clinica La Luz	Madrid
Spain	Clinica Nuestra Señora de América de Madrid	Madrid
Spain	Fundación Jimenez Diaz	Madrid
Spain	Hospital 12 de Octubre	Madrid
Spain	Hospital Clínico San Carlos	Madrid
Spain	Hospital La Princesa	Madrid
Spain	Hospital Puerta de Hierro	Madrid
Spain	Hospital Ramón Y Cajal	Madrid
Spain	Hospital Universitario de Torrejón	Madrid
Spain	Hospital Virgen de La Victoria	Málaga
Spain	Hospital Universitario Central de Asturias	Oviedo
Spain	Hospital Son Espases	Palma De Mallorca
Spain	Hospital Universitario de Navarra	Pamplona
Spain	Hospital Universitario de Salamanca	Salamanca
Spain	Hospital Marqués de Valdecilla	Santander
Spain	Hospital Clínico de Santiago	Santiago De Compostela
Spain	Hospital Virgen Del Rocio	Sevilla
Spain	Hospital Universitario de Canarias	Tenerife
Spain	Hospital Clínico de Valencia	Valencia
Spain	Hospital La Fe	Valencia
Spain	Hospital Clinico Universitario de Valladolid	Valladolid
Spain	Hospital Álvaro Cunqueiro	Vigo
Spain	Hospital Miguel Servet	Zaragoza

Sponsors (2)

Lead Sponsor	Collaborator
Spanish Society of Cardiology	Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III

Country where clinical trial is conducted

Spain, 

References & Publications (1)

Amat-Santos IJ, Sanchez-Luna JP, Abu-Assi E, Melendo-Viu M, Cruz-Gonzalez I, Nombela-Franco L, Munoz-Garci AJ, Blas SG, de la Torre Hernandez JM, Romaguera R, Sanchez-Recalde A, Diez-Gil JL, Lopez-Otero D, Gheorge L, Ibanez B, Iniguez-Romo A, Raposeiras-R — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Improvement in NYHA class.	Functional class according to New York Heart Association classification	1 year
Other	Incidence of new Atrial Fibrillation	Diagnosis of new Atrial Fibrillation in patients without history of atrial fibrillation at baseline	1 year
Other	Safety endpoints	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)	1 year
Other	Rate of treatment switch (crossovers)	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
Primary	Incidence rate of the composite of all-cause mortality or worsening heart failure (HF)	All-cause mortality and worsening HF (including hospitalization for HF or an urgent visit resulting in intravenous therapy for HF).	1 year
Secondary	Incidence rate all-cause mortality	All cause mortality	1 year
Secondary	Incidence rate of Cardiovascular death	Mortality secondary to cardiovascular cause	1 year
Secondary	Incidence rate of Hospitalization for Heart Failure	Heart Failure requiring hospital admission	1 year
Secondary	Incidence rate of Urgent Heart Failure visits	Urgent Heart Failure visit requiring intravenous therapy	1 year
Secondary	Incidence rate of the composite of Heart Failure hospitalization or Cardiovascular death	Composite of Heart Failure hospitalization or Cardiovascular death	1 year
Secondary	Total number of Heart Failure hospitalizations and Cardiovascular deaths	Total number of (first and recurrent) Heart Failure hospitalizations and Cardiovascular deaths	1 year

External Links

•   Web Page of DapaTAVI trial