Heart FailurePhase 4TREASURENCT06341101
Timely Recovery After Subclinical Heart Failure
A Phase 4 study testing Perindopril in people with Heart Failure and Diastolic Dysfunction, run by Academisch Ziekenhuis Maastricht at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Heart Failure, Diastolic Dysfunction
- What is being tested?
- Perindopril
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteNetherlands
- Study dates
- 26 Mar 2024to 1 Mar 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
AZMaastricht
Maastricht, Limburg, 6202AZ
Marc Spaanderman, Prof, +31(0)43-3874145, zenab.mohseni@mumc.nl
About this study
Official title: Timely Recovery After Subclinical Heart Failure (TREASURE Trial)
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:
- Reversibility of structural and functional myocardial impairment in asymptomatic HF towards healthy values;
- The progression from asymptomatic to symptomatic HF (symptoms scored based on the NYHA criteria);
- Cardiovascular performance (volume- and pressure load), cardio metabolic risk factors (glucose metabolism, lipid status, kidney function) and quality of life (questionnaires);
- Novel biomarkers and relevant microRNA's indicative for hypertrophy, fibrosis inflammation and ischemia.
Read more
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
- Being tested
- Perindopril
- Keywords
- Pre-Eclampsia, hypertension, heart failure, treatment
- Medical subject headings
- Heart Failure, Pre-Eclampsia, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PerindoprilDrug
Also called Valsartan
In case of side effects Perindopril will be replaced by Valsartan
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
No left Ventricular Hypertrophy
Left ventricular mass index <95 g/m2
Measured: From enrollment to the end of treatment after 2 years
No concentric remodeling
Relative Wall Thickness ≤0.43
Measured: From enrollment to the end of treatment after 2 years
No impaired systolic function
Left ventricular ejection fraction ≥55%
Measured: 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
Measured: From enrollment to the end of treatment after 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2024
- Study start26 Mar 2024 (estimated)
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Academisch Ziekenhuis Maastricht
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Responsible party
- Principal investigator, Zenab Mohseni, Academisch Ziekenhuis Maastricht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06341101
- Sponsor's protocol ID
- 2022-503135-33-00
- Other IDs
- 2022-503135-33-00
- Acronym
- TREASURE
- Status last verified
- Mar 2024
- First submitted
- 26 Feb 2024
- Last updated
- 2 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Timely Recovery After Subclinical Heart Failure (TREASURE Trial)
- ClinicalTrials.gov ID
- NCT06341101
- Acronym / sponsor ID
- TREASURE / 2022-503135-33-00
- Conditions
- Heart Failure, Diastolic Dysfunction
- Keywords
- Pre-Eclampsia, hypertension, heart failure, treatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Academisch Ziekenhuis MaastrichtUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- 26 Mar 2024 (estimated)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 2 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Reversibility of structural and functional myocardial impairment in asymptomatic HF towards healthy values;
- The progression from asymptomatic to symptomatic HF (symptoms scored based on the NYHA criteria);
- Cardiovascular performance (volume- and pressure load), cardio metabolic risk factors (glucose metabolism, lipid status, kidney function) and quality of life (questionnaires);
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group (Perindopril 2 mg) | Experimental | Drug: PerindoprilEligible 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. |
| 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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;
Key exclusion criteria (5 listed)
- Intention to pursue pregnancy within 2 years;
- Already using antihypertensive medication;
- Suffering diabetes mellitus, kidney failure (GFR\&lt;60 ml/min/1.73m2), pre-existent auto-immune disease and/or liver insufficiency;
- Breastfeeding during participation;
- Previous angio-edema
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PerindoprilAlso: ValsartanIn case of side effects Perindopril will be replaced by Valsartan | Drug | Intervention group (Perindopril 2 mg) |
Primary outcome
No left Ventricular Hypertrophy
Time frame: From enrollment to the end of treatment after 2 years
Left ventricular mass index <95 g/m2
No concentric remodeling
Time frame: From enrollment to the end of treatment after 2 years
Relative Wall Thickness ≤0.43
No impaired systolic function
Time frame: From enrollment to the end of treatment after 2 years
Left ventricular ejection fraction ≥55%
Normal diastolic function
Time frame: From enrollment to the end of treatment after 2 years
Septal e'≥8 and Lateral e'≥10 and Average e'≥9 and LA <34 cc/m2
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Perindopril in people with Heart Failure and Diastolic Dysfunction, run by Academisch Ziekenhuis Maastricht at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
No left Ventricular Hypertrophy (time frame: From enrollment to the end of treatment after 2 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2024.