A Phase 4 interventional study of Perindopril in Heart Failure and Diastolic Dysfunction, sponsored by Academisch Ziekenhuis Maastricht. Recruiting at 1 site in Netherlands. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-02.
Sponsored by Academisch Ziekenhuis Maastricht · Phase 4, Interventional, and Treatment
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.
6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.
This study's planned enrollment of 130 is above the median of 76 across 4,049 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →Academisch Ziekenhuis Maastricht is the lead sponsor of 23 studies on the registry; 8 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Perindopril
Eligible subjects will be counselled and upon informed consent randomized for either medication or care as usual (i.e. no medication).
In case of side effects Perindopril will be replaced by Valsartan
Also known as: Valsartan
No left Ventricular Hypertrophy
Left ventricular mass index \<95 g/m2
Time frame: From enrollment to the end of treatment after 2 years
No concentric remodeling
Relative Wall Thickness ≤0.43
Time frame: From enrollment to the end of treatment after 2 years
No impaired systolic function
Left ventricular ejection fraction ≥55%
Time frame: 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
Time frame: From enrollment to the end of treatment after 2 years
Start is estimated for Mar 2024; primary completion for Mar 2026, 23 months later.
Of 164 non-industry phase 4 interventional studies under Heart Failure, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 56. This study's planned 23 months is below that.
Counting every sponsor, half of 183 studies reached it within 31 months; a quarter within 22 and three quarters within 56.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Studies of the drug tested here: Perindopril
Academisch Ziekenhuis Maastricht