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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
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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