Overview
Sponsor-declared trial summary
Subclinical heart failure
The main-objective is to evaluate the effect of an angiotensin-converting-enzyme (ACE) inhibitor compared to care as usual (i.e. no medication) during a two-year open-labeled treatment period in women with asymptomatic heart failure (HF) on reversibility of aberrant cardiac remodeling in asymptomatic HF towards healthy…
Key facts
- Sponsor
- University Hospital Maastricht
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- 26 Mar 2024 → ongoing
- Decision date (initial)
- 2023-07-28
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Nederlandse Organisatie voor Wetenschappelijk Onderzoek (NWO)
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Efficacy
The main-objective is to evaluate the effect of an angiotensin-converting-enzyme (ACE) inhibitor compared to care as usual (i.e. no medication) during a two-year open-labeled treatment period in women with asymptomatic heart failure (HF) on reversibility of aberrant cardiac remodeling in asymptomatic HF towards healthy values.
Secondary objectives 1
- The secondary objective of this trial is to evaluate the effect of ACE inhibitor on: (i) Cardiovascular (CV) performance (volume- and pressure load), cardio metabolic risk factors (glucose metabolism, lipid status, kidney function) and quality of life (questionnaires) and (ii) Novel biomarkers indicative for hypertrophy, fibrosis inflammation and ischemia.
Conditions and MedDRA coding
Subclinical heart failure
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Open-labelled randomized controlled trial for 2 years We will perform an open-labelled randomized controlled trial for 2 years to investigate whether ACE
inhibitor allows Timely REecovery After SUbclinical heaRt failurE (TREASURE trial).
|
Randomised Controlled | None | Intervention arm (n=65 women): The intervention is an ACE inhibitor (Perindopril 2 mg) Comparator arm (n=65 women): The comparator is care as usual (i.e. no medication) |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Women, aged 18 years and older
- Heart failure stage-B or diastolic dysfunction
- Premenopausal, with or without a history of preeclamptic pregnancy
- ≥½ and ≤ 30 years after the (first) (complicated) pregnancy;
- Last delivery at least 6 months ago
Exclusion criteria 8
- Already using antihypertensive medication
- Systolic blood pressure of ≥180 mmHg and/or diastolic blood pressure of ≥110 mmHg
- Suffering diabetes mellitus, kidney failure (GFR<60 ml/min/1.73m2), pre-existent auto-immune disease and/or liver insufficiency
- Women have the intention to pursue pregnancy within 2 years (as ACE inhibitors may be teratogenic)
- Breastfeeding during participation
- Auto-immune disease(s) prior to the (complicated) pregnancy
- Chronic hypertension prior to the complicated pregnancy
- Women who do not want themselves and/or their general practitioner and specialist(s) to be informed about the test results
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 5
- Left ventricular hypertrophy (Left ventricular mass index ≥95 g/m2)
- Concentric remodeling (relative wall thickness >0.43)
- Impaired systolic function (ejection fraction <55%)
- Significant valve dysfunction (American Society of Echocardiography guidelines)
- Signs of myocardial infarction (MI)
Secondary endpoints 6
- Blood pressure
- Plasma volume
- Quality of life, behavior and symptoms
- Metabolic syndrome
- Renin-angiotensin-aldosterone system
- Novel biomarkers
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
Valsartan 40 mg capsules, hard
PRD1177010 · Product
- Active substance
- Valsartan
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 80 mg milligram(s)
- Max total dose
- 320 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- C09CA03 — VALSARTAN
- Marketing authorisation
- MA807/07401
- MA holder
- AUROBINDO PHARMA (MALTA) LIMITED
- MA country
- Malta
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD10229416 · Product
- Active substance
- Perindopril Tert-Butylamine
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 2 mg milligram(s)
- Max total dose
- 10 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- C09AA04 — PERINDOPRIL
- Marketing authorisation
- PL 11311/0446
- MA holder
- TILLOMED LABORATORIES LTD
- MA country
- XI
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Auxiliary 2
Nitrospray 0,4 mg/devā aerosols lietošanai zem mēles, šķīdums
PRD9379727 · Product
- Active substance
- Glyceryl Trinitrate
- Pharmaceutical form
- SUBLINGUAL SPRAY, SOLUTION
- Route of administration
- SUBLINGUAL USE
- Max daily dose
- 3 mg milligram(s)
- Max total dose
- 3 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- C01DA02 — GLYCERYL TRINITRATE
- Marketing authorisation
- 11-0434
- MA holder
- VIP PHARMA EESTI OU
- MA country
- Latvia
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB20532 · Substance
- Active substance
- Albumin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INJECTION
- Max daily dose
- 1 mCi millicurie(s)
- Max total dose
- 5 mCi millicurie(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
University Hospital Maastricht
- Sponsor organisation
- University Hospital Maastricht
- Address
- P. O. Box 616
- City
- Maastricht
- Postcode
- 6200 MD
- Country
- Netherlands
Scientific contact point
- Organisation
- University Hospital Maastricht
- Contact name
- Transmuraal vrouwen dagcentrum
Public contact point
- Organisation
- University Hospital Maastricht
- Contact name
- Transmuraal vrouwen dagcentrum
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruiting | 130 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Netherlands | 2024-03-26 | 2024-03-26 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-04-29 | Netherlands | Acceptable with conditions 2023-07-28
|
2023-07-28 |