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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-503135-33-00 | Other Identifier | EU trial number |
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| Name | Class |
|---|---|
| ZonMw: The Netherlands Organisation for Health Research and Development | OTHER |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group (Perindopril 2 mg) | Experimental | 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. |
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| Standard care group (i.e. no medication) | No Intervention | Eligible subjects will be counselled and upon informed consent randomized for either medication or care as usual (i.e. no medication). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Perindopril | Drug | In case of side effects Perindopril will be replaced by Valsartan |
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| Measure | Description | Time Frame |
|---|---|---|
| No left Ventricular Hypertrophy | Left ventricular mass index <95 g/m2 | From enrollment to the end of treatment after 2 years |
| No concentric remodeling | Relative Wall Thickness ≤0.43 | From enrollment to the end of treatment after 2 years |
| No impaired systolic function | Left ventricular ejection fraction ≥55% | From enrollment to the end of treatment after 2 years |
| 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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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AZMaastricht | Recruiting | Maastricht | Limburg | 6202AZ | Netherlands |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D011225 | Pre-Eclampsia |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D046110 | Hypertension, Pregnancy-Induced |
| D011248 | Pregnancy Complications |
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| ID | Term |
|---|---|
| D020913 | Perindopril |
| D000068756 | Valsartan |
| ID | Term |
|---|---|
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D014652 | Vascular Diseases |
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D014633 | Valine |
| D000597 | Amino Acids, Branched-Chain |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000601 | Amino Acids, Essential |