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| Name | Class |
|---|---|
| Rijnstate Hospital | OTHER |
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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.
The primary objective is to study the effect of a bariatric surgery strategy on the hierarchical occurrence of: 1) all-cause mortality within 2 years, 2) emergency room visit or hospitalization for HF within 2 years, 3) recurrent ECG-documented AF within 2 years, 4) decrease of ≥30gr of left ventricular (LV) mass on transthoracic echocardiography, and 5) improvement of ≥5 points on the Kansas City Cardiomyopathy Questionnaire (KCCQ).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bariatric surgery strategy | Active Comparator | The intervention group will receive bariatric surgery including an intensive pre- and postoperative treatment scheme |
|
| Standard of Care | No Intervention | The control group will receive standard of care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bariatric surgery strategy | Procedure | Bariatric surgery including an intensive pre- and postoperative treatment scheme |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality | All-cause mortality | 2 years |
| Emergency room visit or hospitalization for HF | Emergency room visit or hospitalization for HF |
| Measure | Description | Time Frame |
|---|---|---|
| Weight reduction | Measuring weight during clinical trial | 2 years |
| Medication changes after surgery | Medication changes after surgery | 2 years |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michiel Rienstra, MD, PhD | Contact | +31503611327 | m.rienstra@umcg.nl | |
| Thomas M Gorter, MD, PhD | Contact | tm.gorter@umcg.nl |
| Name | Affiliation | Role |
|---|---|---|
| Michiel Rienstra, MD, PhD | University Medical Center Groningen | Principal Investigator |
| Dirk Jan van Veldhuisen, MD, PhD | University Medical Center Groningen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rijnstate Hospital | Active, not recruiting | Arnhem | Gelderland | 6815AD | Netherlands | |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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Multicentre, prospective, randomized controlled, open-label clinical trial
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| 2 years |
| Rate of recurrent AF | Recurrent AF documented on ECG | 2 years |
| Decrease of left ventricular mass | Decrease of ≥30gr of LV mass measured by transthoracic echocardiography | 2 years |
| Kansas City Cardiomyopathy Questionnaire improvement | 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 |
| Concomitant cardiovascular conditions and relevant comorbidities | Medical history of patient | 2 years |
| Change in left atrial volume | Change in left atrial volume measured by transthoracic echocardiography | 2 years |
| Change in left ventricular diastolic dysfunction | Change in left ventricular diastolic dysfunction measured by transthoracic echocardiography with the definition according to the leading guidelines | 2 years |
| Change in left ventricular ejection fraction | Change in left ventricular ejection fraction measured by transthoracic echocardiography | 2 years |
| Change in right ventricular function | Change in right ventricular function measured by transthoracic echocardiography with the definition according to the leading guidelines | 2 years |
| Change in diameter of epicardial fat | Change in diameter of epicardial fat measured by transthoracic echocardiography | 2 years |
| Healthcare resource use/costs | Measured with the iMedical Consumption Questionnaire (instrument for measuring medical consumption, costs will be estimated by given answers and relation to known costs of the items of medical consumption) | 2 years |
| Health related quality of life / utility | Measured with the 5-level EQ-5D questionnaire (The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression) | 2 years |
| Thomas M Gorter, MD, PhD |
| University Medical Center Groningen |
| Principal Investigator |
| University Medical Center Groningen |
| Recruiting |
| Groningen |
| Provincie Groningen |
| 9713GZ |
| Netherlands |
| D013568 |
| Pathological Conditions, Signs and Symptoms |