Clinical trial NCT06341101: Timely Recovery After Subclinical Heart Failure
Official title: Timely Recovery After Subclinical Heart Failure (TREASURE Trial)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Heart Failure
Diastolic Dysfunction
Keywords: Pre-Eclampsia
hypertension
heart failure
treatment
Lead sponsor: Academisch Ziekenhuis Maastricht
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2024-04-02
Enrollment: 130
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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;

Exclusion Criteria:

* Intention to pursue pregnancy within 2 years;
* Already using antihypertensive medication;
* Suffering diabetes mellitus, kidney failure (GFR\&amp;lt;60 ml/min/1.73m2), pre-existent auto-immune disease and/or liver insufficiency;
* Breastfeeding during participation;
* Previous angio-edema

Primary outcomes:
measure: No left Ventricular Hypertrophy
timeFrame: From enrollment to the end of treatment after 2 years
measure: No concentric remodeling
timeFrame: From enrollment to the end of treatment after 2 years
measure: No impaired systolic function
timeFrame: From enrollment to the end of treatment after 2 years
measure: Normal diastolic function
timeFrame: From enrollment to the end of treatment after 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: AZMaastricht
state: Limburg
Study officials:
References: