Telematic Intervention for Reversing Frailty Among Older Patients with Aortic Stenosis Undergoing Transcatheter Aortic Valve Intervention. the TELE-FRAIL TAVI Clinical Trial

NCT06742970 | Not Yet Recruiting

• 1 other identifier: TELE-FRAIL TAVI
• Study Type: interventional
• Target: 206
• Locations: 1 country
• Sites: 1

Brief Summary

The TELE FRAIL clinical trial is a randomized trial designed to compare, among older frail patients with aortic stenosis undergoing transcatheter valve intervention (TAVI), the impact of usual care after vs a telematic intervention (including a supervised exercise training program, nutrition and education) on frailty reversal and clinical outcomes three months after the TAVI procedure. The trial will include older patients a with baseline frailty criteria with severe AS undergoing TAVI. A comprehensive geriatric assessment will be performed after the TAVI procedure in all patients. Inclusion criteria will be: a) patients aged 75 years or older; b) severe symptomatic aortic stenosis, as defined by a mean aortic gradient≥40 mmHg and/or an aortic valve area \< 1cm2 measured by transtoracic echocardiography; c) performance of successful TAVI during the admission, and d) baseline frailty criteria, as defined by Short Physical Performance Battery test value \<10 and a FRAIL scale value ≥3. Exclusion criteria will be: a) negative to participate in the trial; b) unability to undergo a comprehensive geriatric assessment or study related procedures ; c) unability to complete clinical follow up, and d) life expectancy lower than one year. Patients will be randomized (1:1) to intervention or control arms before hospital discharge after the TAVI procedure. Patients assigned to the intervention will undergo a telematic intervention during the first 90 days after the admission. Trained nurses form an specialized company will contact patients by videocalls at weeks 1,3,5,7,9,11 an12 months. This telematic intervention will include 1) a supervised exercise program (based on an adaptation of the VIVI-FRAIL program) during this 12 weeks; 2) nutrition intervention: The investigator team will provide patients with nutrition supplements for the first 12 weeks after the admission. Patients will take daily a dose of 200 ml of hypercaloric hyperproteic supplements one hour after performing the corresponding exercise training session. Patients will also receive information about the optimal dieta adapted to their clinical profile; and c) health education about the disease, the importance of adherence to medical treatments and recommendations and the best measures for preventing complications. Main outcome measured will be the proportion of patients with frailty (as measured by a Short Physical Performance Battery test value \<10) 3 months after the admission. Secondary outcomes will include 1) the number of days alive out of hospital during the first year, 2) need for readmission at 3 months and at one year, 3) overall mortality at one year, 4) incidence of cardiovascular events (myocardial infarction, need for unplanned revascularization or stroke) at 3 months and at one year, 5) proportion of frail patients (SPPB\<10) at one year, 6)disability for acitivies of daily living (Barthel index) at three months and at one year, 7) nutritional risk (as measured by the MA-Sf test) at three months and at one year and 8) quality of life (as defined by the EQ-5D-5L test) at three months and at one year.

Conditions

Aortic Stenosis

Keywords

frailty; aortic stenosis; TAVI; exercise; nutrition; older

Outcome Measures

Primary Outcomes (1)

• frailty 3 months after the admission

  SPPB value \<10

  3 months after the admission

Study Arms (2)

Usual care after TAVI

NO INTERVENTION

3 months usual care after TAVI

Telematic intervention

EXPERIMENTAL

Telematic intervention will be performed by a specialized company hired by the investigational team. Trained nurses will contact patients assigned to the intervention groups by videocalls at weeks 1,3,5,7,9,11 and 12 after the admission. The specialized nurses will supervise the exercise program sessions (based on an adaptation of he VIVI FRAIL program), correcting potential mistakes and recommending the optimal way for performing the training program. Patients will take a 200 ml dose of hyperproteic, hypercaloric nutrition supplements daily one hour after performing the exercise session. Information about the optimal diet adapted to the clinical profile of patients will be also provided. Additionally, health information about the disease, the importance of adherence to treatments and recommendations and the best measures for controling cardiovascular risk factors, comorbidities and avoiding clinical complications will be also provided

Combination Product: Telematic intervention

Interventions

Telematic intervention COMBINATION_PRODUCT

Telematic intervention will be performed by a specialized company hired by the investigational team. Trained nurses will contact patients assigned to the intervention groups by videocalls at weeks 1,3,5,7,9,11 and 12 after the admission. The specialized nurses will supervise the exercise program sessions (based on an adaptation of he VIVI FRAIL program), correcting potential mistakes and recommending the optimal way for performing the training program. Patients will take a 200 ml dose of hyperproteic, hypercaloric nutrition supplements daily one hour after performing the exercise session. Information about the optimal diet adapted to the clinical profile of patients will be also provided. Additionally, health information about the disease, the importance of adherence to treatments and recommendations and the best measures for controling cardiovascular risk factors, comorbidities and avoiding clinical complications will be also provided

Telematic intervention

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• older patients with aortic stenosis undergoing TAVI
• baseline frailty criteria (SPPB \<10)

You may not qualify if:

• unability to sign informed consent
• unability to complete geriatric assessment
• unability to complete follow up

Sponsors & Collaborators

• Spanish Society of Cardiology: lead

Study Sites (1)

Calle de Nuestra Señora de Guadalupe, Nº 5 y 7 28028, Madrid (España)

Madrid, Spain, 28028, Spain

Location

Related Publications (1)

• Bernal-Labrador E, Romaguera R, Garcia-Blas S, Regueiro A, Serra V, Asmarats L, Tizon-Marcos H, Agudelo V, Scardino C, Casanova-Sandoval JM, Rodriguez-Gabella T, Jimenez-Mendez C, Perez-Rivera A, Robles-Gamboa C, Ayesta A, Diez-Villanueva P, Raposeiras-Roubin S, Amat-Santos IJ, Esteve-Pastor A, Veiga-Fernandez G, Anguita M, Marti-Sanchez D, Martinez-Velilla N, Cortes L, Calvo E, Asimbaya S, Formiga F, Ariza-Sole A. Telematic intervention on frailty in patients undergoing TAVI. Design of the TELE-FRAIL TAVI clinical trial. REC Interv Cardiol. 2025 Jul 10;7(4):223-228. doi: 10.24875/RECICE.M25000519. eCollection 2025.

  PMID: 41333125 DERIVED

MeSH Terms

Conditions

Aortic Valve Stenosis; Frailty; Motor Activity

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Central Study Contacts

Blanca Miranda Serrano BMS Dr, MD

CONTACT

0034-91724 23 70

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: December 15, 2024
• First Posted: December 19, 2024
• Study Start: January 1, 2025
• Primary Completion: September 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 19, 2024

Record last verified: 2024-11

Locations

ES (1)