Timely Recovery After Subclinical Heart Failure

NCT ID: NCT06341101

Last Updated: 2024-04-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-26
• Study Completion Date: 2026-03-01

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.

Conditions

Heart Failure; Diastolic Dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Perindopril

Intervention Type: DRUG

In case of side effects Perindopril will be replaced by Valsartan

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).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Perindopril

In case of side effects Perindopril will be replaced by Valsartan

Intervention Type: DRUG

Other Intervention Names

Valsartan

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<60 ml/min/1.73m2), pre-existent auto-immune disease and/or liver insufficiency;
• Breastfeeding during participation;
• Previous angio-edema

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

ZonMw: The Netherlands Organisation for Health Research and Development

OTHER

Sponsor Role: collaborator

Academisch Ziekenhuis Maastricht

OTHER

Sponsor Role: lead

Responsible Party

Zenab Mohseni

PI

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

AZMaastricht

Maastricht, Limburg, Netherlands

Site Status: RECRUITING

Countries

Netherlands

Facility Contacts

Marc Spaanderman, Prof

Role: primary

zenab.mohseni@mumc.nl

+31(0)43-3874145

Other Identifiers

2022-503135-33-00

Identifier Type: OTHER

Identifier Source: secondary_id

2022-503135-33-00

Identifier Type: -

Identifier Source: org_study_id