Timely Recovery After Subclinical Heart Failure
- Registration Number
- NCT06341101
- Lead Sponsor
- Academisch Ziekenhuis Maastricht
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 130
- 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;
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention group (Perindopril 2 mg) Perindopril Eligible subjects will be counselled and upon informed consent randomized for either medication or care as usual (i.e. no medication). After a complete cardiovascular assessment, medication will be initiated open-labeled (Perindopril 2 mg or no medication). In case of side effects Perindopril will be replaced by Valsartan 40 mg twice daily. A blood pressure below 120/80 mmHg is targeted. Blood pressure will be measured once per two weeks until the targeted blood pressure is achieved or until medication dosage has increased 4 times, corresponding Perindopril 10mg as maximum dosage or corresponding Valsartan 320mg (160 mg twice daily) as maximum dosage.
- Primary Outcome Measures
Name Time Method No left Ventricular Hypertrophy From enrollment to the end of treatment after 2 years Left ventricular mass index \<95 g/m2
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
No concentric remodeling From enrollment to the end of treatment after 2 years Relative Wall Thickness ≤0.43
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
AZMaastricht
🇳🇱Maastricht, Limburg, Netherlands