A Study to Evaluate Sacubitril-Valsartan for Left Ventricular Reverse Remodeling in Adults with Congenital Heart Abnormality

Overview

About this study

The purpose of this study is to determine the optimal medical therapy to improve left ventricular (LV) function. Improvement in LV function has the potential to reduce the burden of heart failure and improve clinical outcomes in the Tetralogy of Fallot (TOF) population.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

Adults, >18 years old.
Repaired TOF and LV systolic dysfunction followed in the Adult Congenital Heart Disease Clinic at Mayo Clinic Rochester. LV systolic dysfunction is defined as LVEF < 50% by two-dimensional transthoracic echocardiogram.

Exclusion Criteria:

Stage IV chronic kidney disease defined as creatinine clearance < 30 ml/min.
Hyperkalemia defined as serum potassium > 5.2 mmol/l.
Hypotension defined as systolic blood pressure < 100 mmHg.
History of angioedema.
Pregnancy.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status
Rochester, Minn. Mayo Clinic principal investigator Alexander Egbe, M.B.B.S., M.P.H.	Closed for enrollment

Mayo Clinic Location

Status

Rochester, Minn.

Mayo Clinic principal investigator

Alexander Egbe, M.B.B.S., M.P.H.

Closed for enrollment

More information

Publications

Publications are currently not available

Clinical Trials