NCT04226664

Brief Summary

Pilot multicentre, open-label, parallel-arm randomized controlled trial (RCT) of 60 patients to demonstrate the feasibility of enrolling patients with high-risk cardiovascular disease (CVD) into an RCT of bariatric surgery versus medical weight management (MWM).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 3, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 13, 2020

Completed
10 months until next milestone

Study Start

First participant enrolled

October 30, 2020

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
Last Updated

March 15, 2022

Status Verified

March 1, 2022

Enrollment Period

2.3 years

First QC Date

January 3, 2020

Last Update Submit

March 14, 2022

Conditions

Obesity, MorbidCardiovascular Diseases

Keywords

Bariatric Surgery

Outcome Measures

Primary Outcomes (3)

  • Recruitment rate

    Recruitment rate (target of 60 patients over 24 months or 1.25 patients per centre per month)

    24 months (or when recruitment is complete)

  • Time to intervention administration

    Target of bariatric surgery performed within 30 days of randomization in \>80%

    30 days

  • Crossover rate

    Crossover rate between control and intervention arm

    At study completion (an average of 1.5 years follow-up)

Secondary Outcomes (9)

  • Change in weight at 1 year

    12 months

  • Change in BMI at 1 year

    12 months

  • Composite outcome of cardiovascular mortality, myocardial infarction (MI), stroke and hospitalization for heart failure (HF)

    12 months, and through study completion (an average of 1.5 years follow-up)

  • Change in percent excess weight loss (%) at 1 year

    12 months

  • Change in New York Heart Association (NYHA) Functional Classification at 1 year

    12 months

  • +4 more secondary outcomes

Study Arms (2)

Intervention

ACTIVE COMPARATOR

Bariatric surgery will consist of laparoscopic Roux-en-Y gastric bypass or sleeve gastrectomy performed at the discretion of the surgeon and according to local standards.

Procedure: Bariatric surgery

Control

NO INTERVENTION

Medical Weight Management (MWM) corresponds to the standard medical practice for weight loss that is available at the local participating centre, and thus reflects the local standard of care.

Interventions

Bariatric surgeryPROCEDURE

Although there may be slight variation by centre, Gastric Bypass generally involves creation of a 30-50 cc stomach pouch, which is anastamosed with a Roux limb of jejunum 75-100 cm in length and a biliary limb of 20-30 cm in length. The operation creates a small gastric pouch, with nutrients bypassing the duodenum and proximal jejunum. Sleeve Gastrectomy involves decreasing the size of the stomach to approximately 15% of its original size by resecting a large portion of the stomach along the greater curvature.

Intervention

Eligibility Criteria

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

You may qualify if:

  • Body mass index \>35 kg/m2
  • Age ≥18 years
  • High-risk CVD, defined as the presence of any one of the following:
  • History of MI, multi-vessel percutaneous coronary intervention or multi-vessel coronary artery bypass grafting; OR
  • Coronary artery disease (CAD) with documented stenoses ≥50% in 2 or more major coronary arteries; OR
  • Symptomatic HF (New York Heart Association class ≥2) on optimal HF therapy for ≥3 months, AND documented HF hospitalization within the last 12 months, OR baseline N-terminal pro B-type natriuretic peptide (NT-pro BNP) \>400 pg/ml;44, 45 OR
  • Documented AF with CHA2DS2-VASc stroke risk score (congestive heart failure/ left ventricular dysfunction, hypertension, age ≥ 75 years \[2 points\], diabetes, history of stroke/ transient ischemic attack \[2 points\], vascular disease, age 65-74 years and female sex) of ≥2; OR
  • History of ischemic stroke; OR
  • Peripheral artery disease, defined as prior aorto-femoral bypass surgery, limb bypass surgery, or percutaneous transluminal angioplasty revascularization of the iliac, infra-inguinal arteries or carotids; or limb or foot amputation for arterial vascular disease; or ≥50% carotid or peripheral artery stenosis
  • Patient is deemed eligible to undergo bariatric surgery according to local practice guidelines

You may not qualify if:

  • Hospital admission for HF within 30 days of enrolment
  • Myocardial infarction, stroke or coronary revascularization in prior 30 days.
  • Percutaneous coronary intervention with a drug eluting stent in prior 90 days.
  • Pregnancy
  • Contraindication to bariatric surgery (atrophic gastritis, diabetes mellitus type 1, prior laparotomy, liver cirrhosis with portal hypertension, uncontrolled drug or alcohol dependence, prior bariatric surgery, massive ventral hernia, severe chronic obstructive pulmonary disease)
  • Life expectancy \<2 years from non-cardiovascular causes.
  • Risk of general anesthesia deemed too excessive
  • Current drug or alcohol dependency (within 6 months of referral)
  • Recent major cancer (life threatening, within last 2 years)
  • Untreated or inadequately treated psychiatric illness
  • Inability to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

RECRUITING

Related Links

MeSH Terms

Conditions

Obesity, MorbidCardiovascular Diseases

Interventions

Bariatric Surgery

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BariatricsObesity ManagementTherapeuticsSurgical Procedures, Operative

Study Officials

  • Jorge Wong, MD MPH FRCPC

    PHRI, Hamilton Health Sciences, McMaster University

    PRINCIPAL INVESTIGATOR

  • Aristithes Doumouras, MD MPH FRCSC

    St. Joseph's Healthcare, McMaster University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tara McCready, PhD, MBA

CONTACT

905-521-2100tara.mccready@phri.ca

Wanna Fong

CONTACT

905-521-2100wanna.fong@phri.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Individuals who meet study eligibility criteria will be randomized in 1:1 fashion to bariatric surgery (intervention arm) or MWM (control arm).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2020

First Posted

January 13, 2020

Study Start

October 30, 2020

Primary Completion

February 1, 2023

Study Completion

May 1, 2023

Last Updated

March 15, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)