RecruitingPhase 4NCT06341101

Timely Recovery After Subclinical Heart Failure

Timely Recovery After Subclinical Heart Failure (TREASURE Trial)


Sponsor

Academisch Ziekenhuis Maastricht

Enrollment

130 participants

Start Date

Mar 26, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this randomized controlled trial is to assess the effectiveness of ACE inhibitors versus standard care) in reversing asymptomatic heart failure (HF stage-B) and/or diastolic dysfunction during a two-year open-label treatment period for formerly preeclamptic women on: 1. Reversibility of structural and functional myocardial impairment in asymptomatic HF towards healthy values; 2. The progression from asymptomatic to symptomatic HF (symptoms scored based on the NYHA criteria); 3. Cardiovascular performance (volume- and pressure load), cardio metabolic risk factors (glucose metabolism, lipid status, kidney function) and quality of life (questionnaires); 4. Novel biomarkers and relevant microRNA's indicative for hypertrophy, fibrosis inflammation and ischemia. Eligible subjects will be counselled and upon informed consent randomized for either medication group (n=65) or care as usual group (n=65). After a complete cardiovascular assessment, medication will be initiated open-labeled (Perindopril 2 mg or no medication). Thereafter, standard medical check-ups (blood pressure, ECG, kidney function, transthoracic cardiac ultrasound, endothelial function, quality of life questionnaires, medical history taking, blood and urine banking) will be performed every six months for two years. Researchers will compare ACE inhibitor (Perindopril 2 mg) and care as usual (i.e. no medication) to investigate whether ACE inhibitor allows timely recovery after subclinical heart failure.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study looks at early heart changes in women who had preeclampsia (high blood pressure during pregnancy) versus those with uncomplicated pregnancies, to see whether early treatment can help reverse silent (asymptomatic) heart dysfunction before it worsens. **You may be eligible if...** - You are a premenopausal woman, 18 or older - You gave birth 6 months to 30 years ago - You have had either a preeclamptic pregnancy or a normal pregnancy - You are attending Maastricht University Medical Center for cardiovascular screening - You have been found to have subclinical (silent) heart failure or diastolic dysfunction (stiff heart) on testing **You may NOT be eligible if...** - You plan to become pregnant within the next 2 years - You are already on blood pressure medication - You have diabetes, kidney failure (GFR below 60), pre-existing autoimmune disease, or liver insufficiency - You are currently breastfeeding - You have a history of angioedema (severe allergic swelling) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPerindopril

In case of side effects Perindopril will be replaced by Valsartan


Locations(1)

AZMaastricht

Maastricht, Limburg, Netherlands

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NCT06341101


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