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

Sponsor

Mayo Clinic (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06150560

Collaborator

National Heart, Lung, and Blood Institute (NHLBI) (NIH)

120

Enrollment

Location

Arms

Anticipated Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Coarctation of Aorta High Blood Pressure	Drug: Losartan Drug: Amlodipine Drug: Placebo	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Supportive Care

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

Anticipated Study Start Date :

Dec 1, 2023

Anticipated Primary Completion Date :

Jun 1, 2028

Anticipated Study Completion Date :

Jun 1, 2028

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Losartan Group Subjects with Coarctation of Aorta (COA) and high blood pressure will receive Losartan.	Drug: Losartan 50mg administered orally once daily for 52 weeks. Other Names: Cozaar
Active Comparator: Amlodipine Group Subjects with Coarctation of Aorta (COA) and high blood pressure will receive Amlodipine.	Drug: Amlodipine 5mg Amlodipine administered orally once daily for 52 weeks.
Placebo Comparator: Placebo Group Subjects with Coarctation of Aorta (COA) and high blood pressure will receive Placebo.	Drug: Placebo Oral capsules that contain no active drug ingredients administered orally once daily for 52 weeks.

Arm

Intervention/Treatment

Experimental: Losartan Group

Subjects with Coarctation of Aorta (COA) and high blood pressure will receive Losartan.

Drug: Losartan

50mg administered orally once daily for 52 weeks.

Other Names:

Cozaar

Active Comparator: Amlodipine Group

Subjects with Coarctation of Aorta (COA) and high blood pressure will receive Amlodipine.

Drug: Amlodipine

5mg Amlodipine administered orally once daily for 52 weeks.

Placebo Comparator: Placebo Group

Subjects with Coarctation of Aorta (COA) and high blood pressure will receive Placebo.

Drug: Placebo

Oral capsules that contain no active drug ingredients administered orally once daily for 52 weeks.

Outcome Measures

Primary Outcome Measures

Change in Left Ventricular (LV) Fibrosis [Baseline; Week 52]
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).

Secondary Outcome Measures

Change in Exercise Capacity (peak VO2) [Baseline; Week 52]
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic in Rochester	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

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

Investigators

Principal Investigator: Alexander Egbe, MBBS, MPH, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Mayo Clinic Clinical Trials

Publications

None provided.

Responsible Party:

Alexander C. Egbe, Principal Investigator, Mayo Clinic

ClinicalTrials.gov Identifier:

NCT06150560

Other Study ID Numbers:

23-007629
1R01HL162830-01A1

First Posted:

Nov 29, 2023

Last Update Posted:

Nov 29, 2023

Last Verified:

Nov 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 29, 2023