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Trial · Interventional

Not yet recruitingPhase 3Registry data

Semaglutide in Patients Undergoing Transcatether Aortic Valve Replacement

Short name REVERSE-TAVR

Overview

Status
Not yet recruiting
Phase
Phase 3
Enrollment
826 participants (estimated)
Sponsor
Leiden University Medical Center · Other
Design
Randomized · Quadruple masking
Countries
Not stated
Start
1 Apr 2026 (estimated)
Primary completion
1 Sept 2030 (estimated)
Completion
1 Apr 2031 (estimated)
First posted
29 Jul 2025
Last update posted
29 Jul 2025
Conditions
Aortic Stenosis · Heart Failure

Timeline

1 trial · 1 not yet recruiting

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2026202720282029203020312032
  1. Ph 3

    REVERSE-TAVR

    NCT07090343

    est. 1 Apr 2026 to est. 1 Apr 2031

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This is a Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial evaluating the safety and efficacy of once-weekly semaglutide 2.4 mg in adult patients undergoing transcatheter aortic valve replacement (TAVR) for severe aortic stenosis (AS) who meet current clinical criteria for semaglutide treatment. A total of 826 participants will be randomized 1:1 to receive semaglutide or placebo as an add-on to standard-of-care, starting 3 months before TAVR and continuing for 24 months post-procedure. The primary endpoint is time to first occurrence of a composite of cardiovascular (CV) death, non-fatal myocardial infarction, non-fatal stroke or transient ischemic accident (TIA), and hospitalization for heart failure (HF). The study is event-driven and powered to detect a 20% relative risk reduction in primary outcome events. This trial aims to address the unmet need for medical therapies that improve outcomes in patients with severe AS following TAVR, with potential for direct clinical implementation.

Interventions

  • Wegovy ®Drug
  • PlaceboDrug

Arms2

  • Active comparator

    Treatment Arm

  • Placebo comparator

    Control Arm

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. CV death, non-fatal myocardial infarction, non-fatal stroke, and hospitalization for HF

    Time frame · From randomization through 12 and 27 months

    Registry description

    From randomization to first occurrence of a composite endpoint consisting of: CV death, non-fatal myocardial infarction, non-fatal stroke, and hospitalization for HF.

Secondary outcomes(14)
  1. Incidence rate of each component of the primary outcome.

    Time frame · From randomization at 12 months and 27 months

  2. Change in high sensitivity C-Reactive Protein (hsCRP) (mg/L)

    Time frame · From randomization at 12 and 27 months

  3. A 5-component composite nephropathy endpoint consisting of: onset of persistent macroalbuminuria, persistent 50% reduction in eGFR compared with baseline (randomization), onset of persistent eGFR < 15 ml/min/1.73m2, initiation of chronic renal replacemen

    Time frame · From randomization at 12 and 27 months

  4. Change in Lipid Profile (mg/dL)

    Time frame · From randomization at 12 and 27 months

  5. Change in waist circumference

    Time frame · From randomization at 12 and 27 months

  6. Change in HbA1c (%, mmol /mol)

    Time frame · From randomization at 12 and 27 months

  7. Change in systolic blood pressure

    Time frame · From randomization at 12 and 27 months

  8. Changes in LV remodeling (echocardiographic assessment of LV size, mass, systolic and diastolic function)

    Time frame · From randomization at 12 and 27 months

  9. Change in loop diuretic medication

    Time frame · From randomization at 12 and 27 months

  10. Change in H2FPEF score

    Time frame · From randomization at 12 and 27 months

    Registry description

    Change in H2FPEF score scale

  11. Change in NT-proBNP

    Time frame · From randomization at 12 and 27 months

  12. Change in KCCQ score

    Time frame · From randomization at 12 and 27 months.

    Registry description

    Change in the KCCQ score scale

  13. Subject experiencing deterioration in NYHA functional class

    Time frame · From randomization at 12 and 27 months

    Registry description

    Subject experiencing deterioration in NYHA functional class

  14. Change in body weight (%)

    Time frame · From randomization at 12 and 27 months.

    Registry description

    Change in body weight from randomization.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

2 studies on this page

Indexing hint: Randomized controlled trial · 2024

4 results

Semaglutide versus placebo in patients with heart failure and mildly reduced or preserved ejection fraction: a pooled analysis of the SELECT, FLOW, STEP-HFpEF, and STEP-HFpEF DM randomised trials.

Kosiborod et al. 2024Lancet (London, England)cited by 232

PMID 39222642DOI 10.1016/s0140-6736(24)01643-xPUB-39222642

Full text at the publisher4 results

Indexing hint: Randomized controlled trial · 2016

8 results

Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes.

Marso et al. 2016The New England journal of medicinecited by 5,002

PMID 27633186DOI 10.1056/nejmoa1607141PUB-27633186

Rights unknown8 results

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: Subjects are eligible to be included in the trial only if all of the following criteria apply: * Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial. * Adults (≥18 years) undergoing TAVR for severe AS, and * BMI ≥30 kg/m2, or * BMI 27-30 kg/m2, AND at least one of the following: * Dysglycemia (prediabetes or type 2 diabetes) ≥90 days prior to the day of screening with HbA1c of ≤ 10.0% as measured at the screening visit. * Arterial Hypertension * Hypercholesterolemia * Obstructive sleep apnea * History of stroke (ischemic or hemorrhagic) * History of myocardial infarction * Symptomatic peripheral artery disease (intermittent claudication with ankle-brachial index \<0.85, peripheral arterial revascularization procedure, or amputation due to atherosclerotic disease) Exclusion Criteria: * Treatment with an GLP-1 receptor agonist within the previous 90 days. * Myocardial infarction, stroke, hospitalization for unstable angina or transient ischemic attack within the previous 60 days. * Planned coronary, carotid or peripheral artery revascularization known on the day of screening. * eGFR \<25 mL/min/1.73 m² or intermittent hemodialysis or peritoneal dialysis. * Presence of acute pancreatitis within the last 180 days prior to screening. * History or presence of chronic pancreatitis. * Self-reported change in body weight of \>5 kg within 90 days before screening. * Bariatric surgery prior to screening or planned bariatric surgery within the trial time course. * Presence or history of malignant neoplasm within 5 years prior to the day of screening. Basal and squamous cell cancer and any carcinoma in-situ are allowed. * Known or suspected hypersensitivity to trial product(s) or related products. * Participation in any clinical trial of an approved or non-approved device for the treatment of aortic stenosis or obesity within 30 days before screening. * Receipt of any investigational medicinal product within 30 days before screening. * Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method. * Major surgery scheduled for the duration of the trial, affecting walking ability in the opinion of the investigator. * Any disorder, including severe psychiatric disorder, suicidal behavior within 90 days before screening, and suspected drug abuse, which in the investigator´s opinion might jeopardize subject´s safety or compliance with the protocol.

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