DelfaGLP-1 Atlas

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REVERSE-TAVR

Not yet recruitingPhase 3

Semaglutide in Patients Undergoing Transcatether Aortic Valve Replacement

Semaglutide for Reducing Cardiovascular Events in Patients Undergoing Transcatether Aortic Valve Replacement

Asset

Semaglutide

GLP-1 agonist

Listed sites

0

Recruiting sites

—

Enrollment

826

estimated

Study population

Cardiovascular disease, Obesity / overweight

Key I/E criteria

•BMI ≥30•HbA1c ≤10%

Primary endpoint

•4-point MACE (Cardiovascular death, Non-fatal MI, Non-fatal stroke, Heart-failure hospitalization)

Identifiers

Registered as

NCT IDNCT07090343
Org study IDREVERSE-TAVR

Timeline

Milestones

Study first posted2025-07-29actual
Last update posted2025-07-29actual
Study start2026-04-01estimated
Primary completion2030-09-01estimated
Study completion2031-04-01estimated

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Cardiovascular diseaseObesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

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.

Endpoints (15)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Heart failure
5
Cardiometabolic biomarkers
3
Weight & body composition
2
Other (unclassified)
2
Cardiovascular outcomes
1
Glycemic / diabetes
1
Renal / kidney
1

Cardiovascular outcomes

1 endpoint
Primary/protocol endpoint

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

Time frame:From randomization through 12 and 27 months

4-point MACE

time to event, event

componentsCardiovascular death, Non-fatal MI, Non-fatal stroke, Heart-failure hospitalization

Weight & body composition

2 endpoints
Secondary/protocol endpoint

Change in waist circumference

Time frame:From randomization at 12 and 27 months

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Change in body weight (%)

Time frame:From randomization at 12 and 27 months.

Body weight, % change

percent change from baseline, improvement

Glycemic / diabetes

1 endpoint
Secondary/protocol endpoint

Change in HbA1c (%, mmol /mol)

Time frame:From randomization at 12 and 27 months

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Heart failure

5 endpoints
Secondary/protocol endpoint/low confidence

Change in loop diuretic medication

Time frame:From randomization at 12 and 27 months

change from baseline, improvement

Secondary/protocol endpoint

Change in H2FPEF score

Time frame:From randomization at 12 and 27 months

change from baseline, improvement

Secondary/protocol endpoint

Change in NT-proBNP

Time frame:From randomization at 12 and 27 months

NT-proBNP, change

change from baseline, improvement

Secondary/protocol endpoint

Change in KCCQ score

Time frame:From randomization at 12 and 27 months.

KCCQ total score

change from baseline, improvement

Secondary/protocol endpoint

Subject experiencing deterioration in NYHA functional class

Time frame:From randomization at 12 and 27 months

NYHA class, change

categorical status, event

Renal / kidney

1 endpoint
Secondary/protocol endpoint

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

5-point renal composite

composite event, event

componentsuACR, change, eGFR, change, End-stage renal disease, Kidney-replacement therapy

Cardiometabolic biomarkers

3 endpoints
Secondary/protocol endpoint

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

Time frame:From randomization at 12 and 27 months

hs-CRP, change

change from baseline, improvement

LOINC 30522-7

Secondary/protocol endpoint/low confidence

Change in Lipid Profile (mg/dL)

Time frame:From randomization at 12 and 27 months

change from baseline, improvement

Secondary/protocol endpoint

Change in systolic blood pressure

Time frame:From randomization at 12 and 27 months

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Other (unclassified)

2 endpoints
Secondary/protocol endpoint/low confidence

Incidence rate of each component of the primary outcome.

Time frame:From randomization at 12 months and 27 months

event count, event

Secondary/protocol endpoint/low confidence

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

Time frame:From randomization at 12 and 27 months

change from baseline, improvement

Publications (2)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.