NCT06065124|RecruitingDMC
Bariatric Surgery Evaluation and Assessment of Treatment Efficacy - Intervention Trial
BEAT-IT
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BEAT-IT
Sponsor study identifier
interventional
108
1 country
2
Study Start
July 1, 2024
Actual (reported)Primary Completion
October 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
October 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
The goal of this clinical trial is to evaluate if a bariatric surgery strategy will improve clinical endpoints, cardiac parameters and functional status in patients with obesity (with BMI 32-40 kg/m2) and symptomatic HF with preserved or mildly reduced LVEF in combination with AF, as compared to standard of care. Patients will be randomized to either the Intervention group receiving bariatric surgery including an intensive pre- and postoperative treatment scheme or to the control group receiving standard of care.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 23, 2023
Actual (reported)October 3, 2023
Actual (reported)July 1, 2024
Actual (reported)October 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
October 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Hierarchical endpoint
The hierarchical occurrence of: 1) All-cause mortality; 2) Emergency room visit or hospitalization for HF; 3) Recurrent ECG-documented AF; 4) Decrease of ≥30gr of LV mass on transthoracic echocardiography; 5) Improvement of ≥5 points on the Kansas City Cardiomyopathy Questionnaire (Scores are transformed to a range of 0-100, in which higher scores reflect better health status)
2 years
All-cause mortality
2 years
Emergency room visit or hospitalization for HF
2 years
Rate of recurrent AF
2 years
Decrease of left ventricular mass
2 years
Kansas City Cardiomyopathy Questionnaire improvement
2 years
Weight reduction
2 years
Medication changes after surgery
2 years
Concomitant cardiovascular conditions and relevant comorbidities
2 years
The intervention group will receive bariatric surgery including an intensive pre- and postoperative treatment scheme
The control group will receive standard of care
Bariatric surgery including an intensive pre- and postoperative treatment scheme
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Rijnstate Hospital
Arnhem, Gelderland, 6815AD, Netherlands
University Medical Center Groningen
Groningen, Provincie Groningen, 9713GZ, Netherlands
Michiel Rienstra, MD, PhD
University Medical Center Groningen
Dirk Jan van Veldhuisen, MD, PhD
University Medical Center Groningen
Thomas M Gorter, MD, PhD
University Medical Center Groningen
First Submitted
August 23, 2023
First Posted
October 3, 2023
Study Start
July 1, 2024
Actual (reported)Primary Completion
October 2027
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
October 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
April 1, 2025
Record last verified: 2025-03
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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