SEMAGLUTIDE for Resistant hypertension | Obesity

Inclusion criteria

• {"criterion_text":"- Obesity defined as a BMI ≥ 30kg/m2"}
• {"criterion_text":"- Resistant hypertension defined as: o Mean home systolic BP ≥ 130 mmHg measured in duplicate at a minimum of 6 timepoints. o Prescribed three or more anti-hypertensive medications, which should include a diuretic."}
• {"criterion_text":"- Prescribed three or more anti-hypertensive medications at optimal doses, one of which should include a diuretic."}
• {"criterion_text":"- Written informed consent to partake and availability for trial duration."}
• {"criterion_text":"- Adults, aged ≥18 years at the time of signing informed consent."}

Exclusion criteria

• {"criterion_text":"- Comorbidities: Diabetes with a HbA1c ≥53mmol/L or a requirement for insulin treatment or diabetic retinopathy, previous pancreatitis/pancreatic cancer, end stage renal disease (eGFR <15ml/min), congestive heart failure NYHA class IV, limited life expectancy."}
• {"criterion_text":"- Otherwise considered unsuitable by the principal investigator or their primary doctor."}
• {"criterion_text":"- Treatment with any GLP-1 RA or any medication for the indication of obesity within the past 90 days before screening."}
• {"criterion_text":"- Presence or history of chronic pancreatitis or pancreatic cancer."}
• {"criterion_text":"- An episode of acute pancreatitis within the last 180 days."}
• {"criterion_text":"- Patients with severe renal impairment (eGFR < 30 ml/min1.73m2) including patients with end-stage renal disease, patients with severe hepatic impairment, congestive heart failure NYHA class IV, limited life expectancy."}
• {"criterion_text":"- Diabetes with a HbA1c ≥53mmol/L or a requirement for insulin treatment or diabetic retinopathy."}
• {"criterion_text":"- Female who is pregnant, breastfeeding or intends to become pregnant or is of childbearing potential and not using a highly effective contraceptive method."}
• {"criterion_text":"- Hypersensitivity to semaglutide, another GLP1-RA, or excipients of Ozempic®/Wegovy®."}
• {"criterion_text":"- Personal/family history of medullary thyroid cancer or Multiple Endocrine Neoplasia syndrome"}
• {"criterion_text":"- Previous surgery for weight reduction or major gastro-intestinal tract surgery"}

Primary endpoints

• {"endpoint_text":"- Blood pressure measurement: Variability in mean difference in systolic BP (SBP) after 36 weeks. Correlation between home, ambulatory and clinic SBP.","definition_or_measurement_approach":"Mean difference in systolic BP (SBP) after 36 weeks; correlation assessed between home, ambulatory and clinic systolic BP measurements."}
• {"endpoint_text":"- Trial conduct: Recruitment feasibility and reliability - numbers of participants screened, consented, randomized and with final results. Site feasibility - number of sites recruited and site performance (numbers of participants recruited).","definition_or_measurement_approach":"Counts and proportions of participants at each stage (screened, consented, randomized, with final results); site-level recruitment numbers and performance metrics."}
• {"endpoint_text":"- Intervention acceptability: Tolerability of the intervention measured by treatment related participant discontinuation. Participant drop-out","definition_or_measurement_approach":"Rate and reasons for treatment-related discontinuation and overall participant dropout during study period."}
• {"endpoint_text":"- Safety: Proportion, incidence and severity of serious adverse events in those who have taken at least one dose of the intervention.","definition_or_measurement_approach":"Proportion/incidence and severity grading of serious adverse events among participants who received at least one dose."}
• {"endpoint_text":"- Safety: Routine follow-up records the incidence of drug related adverse events of interest and those related to blood pressure lowering if they require medical assessment or hospital admission: Severe gastrointestinal symptoms (preventing everyday activities) • Acute pancreatitis (Atlanta classification).[Banks,2013] • Hypotensive episodes requiring medical review e.g. syncope, falls due to orthostatic symptoms • Acute kidney injury (KDIGO definition)","definition_or_measurement_approach":"Routine follow-up to capture incidence of predefined adverse events (severe GI symptoms, acute pancreatitis per Atlanta classification, hypotensive episodes requiring medical review, acute kidney injury per KDIGO)."}

Secondary endpoints

• {"endpoint_text":"- Clinical: For all randomized patients administered semaglutide compared with placebo, both in addition to healthy lifestyle advice, from baseline to 36 weeks: • Mean difference in home systolic BP • Change in anti-hypertensive medications, • Mean difference in home diastolic BP, • Mean difference in body weight, • Mean difference in ambulatory* and clinic systolic and diastolic BP, • Mean difference in glycated haemoglobin (HbA1c)","definition_or_measurement_approach":"Changes from baseline to 36 weeks in listed clinical measures (home systolic/diastolic BP, ambulatory and clinic BP, body weight, HbA1c) and change in antihypertensive medication use."}
• {"endpoint_text":"- Patient reported: Comparing the trial arm treated with semaglutide with placebo, both in addition to a healthy lifestyle intervention, from baseline to week 36 for: • Change in health-related quality-of-life using the EQ-5D-3L, • Change in health beliefs using the Beliefs about Medicines questionnaire, • Change in medication adherence using the Hill-Bone questionnaire, • Change in health lifestyle behaviours using the Best Health Program questionnaire.","definition_or_measurement_approach":"Patient-reported outcome measures (EQ-5D-3L, Beliefs about Medicines, Hill-Bone adherence, Best Health Program questionnaire) comparing change from baseline to week 36."}
• {"endpoint_text":"- Exploratory: Composite BP change (mean difference in SBP and mean difference in expected mean difference in BP as a result of alterations to anti-hypertensive medications using a treatment intensity score). Novel measures of BP control including SBP Load and Time in Target Range.","definition_or_measurement_approach":"Exploratory composite measures combining SBP change and adjustments in antihypertensive treatment using a treatment intensity score; novel BP control metrics such as SBP Load and Time in Target Range."}

Other endpoints

• {"endpoint_text":"- Exploratory: Composite BP change (mean difference in SBP and mean difference in expected mean difference in BP as a result of alterations to anti-hypertensive medications using a treatment intensity score). Novel measures of BP control including SBP Load and Time in Target Range.","definition_or_measurement_approach":"Exploratory composite and novel BP control metrics as described above."}

Methods

• Recruitment poster (SUPPORT Trial Recruitment Poster) — targeted to potential participants
• Trial recruitment webpage (SUPPORT Trial Recruitment Webpage) — online information for potential participants
• GP notification letters to primary care physicians (GP Notification Letter) — channel to inform GPs in Ireland
• Site Letter of Invitation to recruit sites
• Patient Letter of Invitation to potential participants
• Recruitment arrangements and procedure document ('SUPPORT Trial Recruitment and Informed Consent Procedure')

Ireland

Earliest CTIS Part Ii Submission Date

16-12-2024

Latest Decision Or Authorization Date

23-03-2026

Processing Time Days

462

Number Of Sites

5

Number Of Participants

50

Primary sponsor

Full Name

Trinity College Dublin

Organisation Type

Educational Institution

Country Of Registered Address

Ireland