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Effect of Sacubitril-Valsartan on Cardiac Structure and Function

ConditionCongenital Heart Disease
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic

About this trial

The purpose of this study is to compare changes in cardiac structure and function, biomarkers, and patient reported outcomes between adults with congenital heart disease (ACHD) randomized to angiotensin receptor-neprilysin inhibitor (ARNI) therapy vs placebo.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Congenital Heart Disease Diagnosis

Age 18 or Older

Disqualifiers

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 related to previous ACE or ARB therapy

Trial design

Design model

Parallel

Treatments tested in this trial

  • Entresto Pill

    Drug

    Patients will take a 24/26 mg dose orally, twice daily, for weeks 1 and 2, 49/51 mg orally, twice daily, for weeks 3 and 4, and 97/103 mg orally twice daily, for the remaining 48 weeks (total duration: 52 weeks).

  • Placebo

    Other intervention

    Patients taking placebo tablets will take 1 tablet orally, twice daily

Treatment groups

45 Participants
are divided into 2 treatment groups
Group A: EntrestoExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Ventricular function

Ventricular Function will be determined by indices of Right Ventricle (RV) and Left Ventricle (LV) systolic and diastolic function indices acquired from CMRI and transthoracic echocardiographic imaging.

Time frame
Baseline, Week 52
2

Ventricular structure

Ventricular structure will be determined by Right Ventricle (RV) and Left Ventricle (LV) size and wall thickness acquired from CMRI and transthoracic echocardiographic imaging.

Time frame
Baseline, Week 52
3

Change from baseline in Hs-Troponin

Hs-Troponin will be determined by blood specimen and will be measured in ng/L. A higher value indicates damage to the heart.

Time frame
Baseline, Week 52
4

Change from baseline in Galectin 3

Galectin 3 will be determined by blood specimen and will be measure in ng/mL. A higher value indicates a higher severity of heart disease.

Time frame
Baseline, Week 52

Secondary outcomes

Other outcomes

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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