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

High Blood Pressure Clinical Trial

— VALUE  

Official title:

A Phase III, Randomized, Double-Blind, Placebo Controlled Clinical Trial Evaluating the Benefits and Mechanism Of Action Of Angiotensin-II Receptor Blocker On Cardiovascular Remodeling In Patients With Repaired Coarctation Of Aorta

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06150560
• Other study ID #: 23-007629
• Secondary ID: 1R01HL162830-01A
• Status: Recruiting
• Phase: Phase 3
• Start date: April 2024
• Est. completion date: June 1, 2028

Study information

• Verified date: March 2024
• Source: Mayo Clinic
• Contact: ACHD Research Program
• Phone: (507) 293-2565
• Email: RSTACHDRESPRG[@]mayo.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: June 1, 2028
• Est. primary completion date: June 1, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• B/S1 hypertension; SBP 120-139 average based on 3 office measurements.
• COA Repair prior to age 10
• No residual COA; Based on mean doppler COA gradient <20mmHg within past 12 months

Exclusion Criteria:

• Currently on beta blocker (BB) therapy
• Pregnancy/lactating
• eGFR<30
• Hyperkalemia (serum potassium >5.5mmol/L)
• Severe Aortic or Mitral valve stenosis or regurgitation
• Epicardial CAD diagnosis
• Received antihypertensive medications within the past year

Related Conditions & MeSH terms

• Aortic Coarctation
• Coarctation of Aorta
• High Blood Pressure
• Hypertension

Intervention

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

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Baseline; Week 52
Secondary	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).	Baseline; Week 52