A Study of Angiotensin-II Receptor Blocker on Cardiovascular Remodeling (VALUE Trial)

ConditionsCoarctation of Aorta High Blood Pressure

Trial statusRecruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

Age18+

SponsorMayo Clinic

About this trial

The purpose of this study is to evaluate the effectiveness and mechanism of action of Losartan in the treatment of coarctation of aorta.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

B/S1 hypertension

SBP 100-139 average based on 3 office measurements.

Age 18 or Older

Previous COA Repair

Disqualifiers

Currently on beta blocker (BB) therapy

Pregnancy/lactating

eGFR<30

Hyperkalemia (serum potassium >5.5mmol/L)

Trial design

Design model

Parallel

Treatments tested in this trial

Losartan
Drug
50mg administered orally once daily for 52 weeks.
Amlodipine
Drug
5mg Amlodipine administered orally once daily for 52 weeks.
Placebo
Drug
Oral capsules that contain no active drug ingredients administered orally once daily for 52 weeks.

Treatment groups

120 Participants

are divided into 3 treatment groups

Group A: Losartan GroupExperimental treatment 1 intervention

Group B: Amlodipine GroupActive comparator 1 intervention

Group C: Placebo GroupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Change in Left Ventricular (LV) Fibrosis

LV fibrosis will be measured via indexed Extracellular Volume (iECV) which will be calculated as extracellular volume fraction (ECV%) x LV End Diastolic Volume Index as evaluated during Cardiac Magnetic Resonance Imaging (CMRI).

Time frame

Baseline; Week 52

Secondary outcomes

Change in Exercise Capacity (peak VO2)

Change in Exercise Capacity will be evaluated based on peak VO2, measured as milliliters of oxygen per kilogram of body weight per minute (ml/kg/min), during supine bike cardiopulmonary exercise test (Stress Echocardiogram).

Time frame

Baseline; Week 52

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Source ClinicalTrials.gov

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