Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06341101
Status:
RECRUITING
Last Update Posted:
2024-04-02
First Post:
2024-02-26
Brief Title:
Timely Recovery After Subclinical Heart Failure
Sponsor:
Academisch Ziekenhuis Maastricht
Organization:
Academisch Ziekenhuis Maastricht
Study Overview
Official Title:
Timely Recovery After Subclinical Heart Failure TREASURE Trial
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TREASURE
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 andor 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 microRNAs indicative for hypertrophy fibrosis inflammation and ischemia
Eligible subjects will be counselled and upon informed consent randomized for either medication group n65 or care as usual group n65 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 ie no medication to investigate whether ACE inhibitor allows timely recovery after subclinical heart failure
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 microRNAs indicative for hypertrophy fibrosis inflammation and ischemia
Eligible subjects will be counselled and upon informed consent randomized for either medication group n65 or care as usual group n65 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 ie no medication to investigate whether ACE inhibitor allows timely recovery after subclinical heart failure
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2022-503135-33-00 | OTHER | EU trial number | None |