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Timely Recovery After Subclinical Heart Failure (TREASURE Trial)

Status: Unknown
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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;

Locations
Other Locations
Netherlands
AZMaastricht
RECRUITING
Maastricht
Time Frame
Start Date: 2024-03-26
Completion Date: 2026-03-01
Participants
Target number of participants: 130
Treatments
Experimental: Intervention group (Perindopril 2 mg)
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.
No_intervention: Standard care group (i.e. no medication)
Eligible subjects will be counselled and upon informed consent randomized for either medication or care as usual (i.e. no medication).
Related Therapeutic Areas
Sponsors
Leads: Academisch Ziekenhuis Maastricht
Collaborators: ZonMw: The Netherlands Organisation for Health Research and Development

This content was sourced from clinicaltrials.gov