Timely Recovery After Subclinical Heart Failure

NCT06341101 | Recruiting Phase 4 DMC

• 1 other identifier: 2022-503135-33-00
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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. 1.Reversibility of structural and functional myocardial impairment in asymptomatic HF towards healthy values;
2. 2.The progression from asymptomatic to symptomatic HF (symptoms scored based on the NYHA criteria);
3. 3.Cardiovascular performance (volume- and pressure load), cardio metabolic risk factors (glucose metabolism, lipid status, kidney function) and quality of life (questionnaires);
4. 4.Novel biomarkers and relevant microRNA's indicative for hypertrophy, fibrosis inflammation and ischemia.

Conditions

Heart Failure; Diastolic Dysfunction

Keywords

Pre-Eclampsia; hypertension; heart failure; treatment

Outcome Measures

Primary Outcomes (4)

• No left Ventricular Hypertrophy

  Left ventricular mass index \<95 g/m2

  From enrollment to the end of treatment after 2 years

• No concentric remodeling

  Relative Wall Thickness ≤0.43

  From enrollment to the end of treatment after 2 years

• No impaired systolic function

  Left ventricular ejection fraction ≥55%

  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

  From enrollment to the end of treatment after 2 years

Study Arms (2)

Intervention group (Perindopril 2 mg)

EXPERIMENTAL

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

Standard care group (i.e. no medication)

NO INTERVENTION

Eligible subjects will be counselled and upon informed consent randomized for either medication or care as usual (i.e. no medication).

Interventions

Perindopril DRUG

In case of side effects Perindopril will be replaced by Valsartan

Also known as: Valsartan

Intervention group (Perindopril 2 mg)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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

Sponsors & Collaborators

• Academisch Ziekenhuis Maastricht: lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator

Study Sites (1)

AZMaastricht

Maastricht, Limburg, 6202AZ, Netherlands

RECRUITING

MeSH Terms

Conditions

Heart Failure; Pre-Eclampsia; Hypertension

Interventions

Perindopril; Valsartan

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Valine; Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: February 26, 2024
• First Posted: April 2, 2024
• Study Start: March 26, 2024
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: April 2, 2024

Record last verified: 2024-03

Locations

NL (1)