Diastolic Dysfunction, Heart Failure
Conditions
Keywords
Pre-Eclampsia, hypertension, heart failure, treatment
Brief 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.
Interventions
DRUGPerindopril
In case of side effects Perindopril will be replaced by Valsartan
Sponsors
ZonMw: The Netherlands Organisation for Health Research and Development
Academisch Ziekenhuis Maastricht
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| No left Ventricular Hypertrophy | From enrollment to the end of treatment after 2 years | Left ventricular mass index \<95 g/m2 |
| No concentric remodeling | From enrollment to the end of treatment after 2 years | Relative Wall Thickness ≤0.43 |
| No impaired systolic function | From enrollment to the end of treatment after 2 years | Left ventricular ejection fraction ≥55% |
| Normal diastolic function | From enrollment to the end of treatment after 2 years | Septal e'≥8 and Lateral e'≥10 and Average e'≥9 and LA \<34 cc/m2 |
Countries
Netherlands
Outcome results
None listed