Timely Recovery After Subclinical Heart Failure

Heart Failure Clinical Trial

— TREASURE  

Official title:

Timely Recovery After Subclinical Heart Failure (TREASURE Trial)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06341101
• Other study ID #: 2022-503135-33-00
• Secondary ID: 2022-503135-33-0
• Status: Recruiting
• Phase: Phase 4
• Start date: March 26, 2024
• Est. completion date: March 1, 2026

Study information

• Verified date: March 2024
• Source: Academisch Ziekenhuis Maastricht
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: March 1, 2026
• Est. primary completion date: March 1, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All women who visit Maastricht Univeristy Medical Center+ for Cardiovascular screening with subclinical/asymptomatic heart failure (HF stage-B) and/or diastolic dysfunction;
• Aged 18 years and older;
• Premenopausal women with a history of preeclamptic pregnancy and premenopausal women with a history of normal pregnancy;
• Between 0.5 and 30 years postpartum;

Exclusion Criteria:

• Intention to pursue pregnancy within 2 years;
• Already using antihypertensive medication;
• Suffering diabetes mellitus, kidney failure (GFR<60 ml/min/1.73m2), pre-existent auto-immune disease and/or liver insufficiency;
• Breastfeeding during participation;
• Previous angio-edema

Related Conditions & MeSH terms

• Diastolic Dysfunction
• Heart Failure

Intervention

Drug:
• Perindopril
In case of side effects Perindopril will be replaced by Valsartan

Locations

Country	Name	City	State
Netherlands	AZMaastricht	Maastricht	Limburg

Sponsors (2)

Lead Sponsor	Collaborator
Academisch Ziekenhuis Maastricht	ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	No left Ventricular Hypertrophy	Left ventricular mass index <95 g/m2	From enrollment to the end of treatment after 2 years
Primary	No concentric remodeling	Relative Wall Thickness =0.43	From enrollment to the end of treatment after 2 years
Primary	No impaired systolic function	Left ventricular ejection fraction =55%	From enrollment to the end of treatment after 2 years
Primary	Normal diastolic function	Septal e'=8 and Lateral e'=10 and Average e'=9 and LA <34 cc/m2	From enrollment to the end of treatment after 2 years