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Bariatric Surgery Evaluation and Assessment of Treatment Efficacy - Intervention Trial

NCT06065124 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2025-04-01

No results posted yet for this study

Summary

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.

Conditions

Interventions

PROCEDURE

Bariatric surgery strategy

Bariatric surgery including an intensive pre- and postoperative treatment scheme

Sponsors & Collaborators

  • Rijnstate Hospital

    collaborator OTHER

  • University Medical Center Groningen

    lead OTHER

Principal Investigators

  • 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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-01
Primary Completion
2027-10-31
Completion
2027-10-31

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06065124 on ClinicalTrials.gov