NCT05914051

Brief Summary

The aim is to assess the response of cardiac output and stroke volume to volume preload optimization in patients with severe aortic stenosis treated with aortic prosthesis implantation.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 23, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 22, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

June 22, 2023

Status Verified

June 1, 2023

Enrollment Period

6 months

First QC Date

March 23, 2023

Last Update Submit

June 12, 2023

Conditions

TAVI

Outcome Measures

Primary Outcomes (1)

  • Cardiac output after valve implant

    Cardiac output (l/min) after TAVI

    "1 year"

Secondary Outcomes (1)

  • Stroke volume after valve implant

    "1 year"

Other Outcomes (2)

  • Need of inotropes

    "1 year"

  • HR after TAVI

    "1 year"

Study Arms (2)

Volume preload optimization.

EXPERIMENTAL

Volume overload with 250 cc saline solution will be performed in the intervention arm, verifying the response of the cardiac output and stroke volume with non invasive continue monitoring.

Other: Colloid preload

Control group

NO INTERVENTION

Standard care without volume preload.

Interventions

Colloid preloadOTHER

250 cc of colloid preload solution will be infused in the intervention group

Volume preload optimization.

Eligibility Criteria

Age18 Years - 110 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aortic valve stenosis with echocardiographic derived criteria: mean gradient \>40 mmHg or jet velocity greater than 4.0 m/s or an initial aortic valve area of \< 0.8 cm2

You may not qualify if:

  • Cardiogenic shock.
  • Life expectancy \< 1 year.
  • Need of mechanic ventilation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Leire Unzue, PhD

CONTACT

0034917089900leireunzue@yahoo.es

Miguel Rodríguez del Río, MD

CONTACT

0034917089900mrrio1980@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PRELOAD-TAVI Trial

Study Record Dates

First Submitted

March 23, 2023

First Posted

June 22, 2023

Study Start

October 1, 2023

Primary Completion

April 1, 2024

Study Completion

July 1, 2024

Last Updated

June 22, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, CSR
Time Frame
At recruitment and after study conclusion