Bariatric Surgery Evaluation and Assessment of Treatment Efficacy in Heart Failure with Preserved Ejection Fraction - Intervention Trial

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 45
Maximum Age: 70
Healthy Volunteers: f
View:

• Signs and symptoms of HF according to the Europeans Society of Cardiology guideline;

• Left ventricular ejection fraction ≥40%;

• HFA-PEFF score ≥5 or HFA-PEFF score 2-4 in combination with positive stress test;

• Between 45 and 70 years of age;

• BMI 32-40 kg/m2;

• Paroxysmal or persistent AF with a rhythm control strategy;

• Willing to undergo both treatment strategies;

• Written informed consent.

Locations
Other Locations
Netherlands
Rijnstate Hospital
ACTIVE_NOT_RECRUITING
Arnhem
University Medical Center Groningen
RECRUITING
Groningen
Contact Information
Primary
Michiel Rienstra, MD, PhD
m.rienstra@umcg.nl
+31503611327
Backup
Thomas M Gorter, MD, PhD
tm.gorter@umcg.nl
Time Frame
Start Date: 2024-07-01
Estimated Completion Date: 2027-10
Participants
Target number of participants: 108
Treatments
Active_comparator: Bariatric surgery strategy
The intervention group will receive bariatric surgery including an intensive pre- and postoperative treatment scheme
No_intervention: Standard of Care
The control group will receive standard of care
Sponsors
Leads: University Medical Center Groningen
Collaborators: Rijnstate Hospital

This content was sourced from clinicaltrials.gov