NCT06341101

Timely Recovery After Subclinical Heart Failure

Timely Recovery After Subclinical Heart Failure (TREASURE Trial)

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 130 (estimated)
• Sponsor: Academisch Ziekenhuis Maastricht · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Heart Failure
• Diastolic Dysfunction

Interventions

Type	Name	Description
DRUG	Perindopril	In case of side effects Perindopril will be replaced by Valsartan

Timeline

• Start date: 2024-03-26
• Primary completion: 2026-03-01
• Completion: 2026-03-01
• First posted: 2024-04-02
• Last updated: 2024-04-02

Locations

1 site across 1 country: Netherlands