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Clinical Trial Details — Status: Recruiting

Administrative data

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

Study information

Verified date May 2024
Source Mayo Clinic
Contact ACHD Research Program
Phone (507) 293-2565
Email RSTACHDRESPRG@mayo.edu
Is FDA regulated No
Health authority
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

Study Design


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
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