Heart Failure With Preserved Ejection FractionPhase 2/3SOGALDI-PEFNCT05676684
Dapagliflozin With or Without Spironolactone for HFpEF
A Phase 2/3 study testing Dapagliflozin and Spironolactone + Dapagliflozin in people with Heart Failure With Preserved Ejection Fraction, run by Universidade do Porto at 2 sites in Portugal.
Trial summary
Heart failure (HF) is a condition in which the heart does not contract ("pump") or relax well, leading to insufficient perfusion of vital organs. Ankle swelling, fatigue, and breathlessness are some of the features of this syndrome. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Heart Failure With Preserved Ejection Fraction
- What is being tested?
- Dapagliflozin and Spironolactone + Dapagliflozin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 2 sitesPortugal
- Study dates
- 15 Sep 2022to 29 Nov 2024
- Phase
- Phase 2/3
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of informed consent prior to any study specific procedures
- HFpEF diagnosis* (irrespective of time since diagnosis)
- Male or female patients, aged ≥50 years
- NYHA Class II-IV
- LVEF > 40%
- NT-pro BNP ≥220 pg/mL or BNP ≥80 pg/mL if in sinus rhythm (SR)
Show all 28Show fewer
- NT-pro BNP ≥660 pg/mL or BNP ≥240 pg/mL if in atrial fibrillation (AF)
- Echocardiography with at least one of the following criteria:
- LAVI ≥29 ml/m2 (≥34 ml/m2 if AF)
- Lateral E/e' ≥9
- LVMI ≥115 g/m2 If male or ≥95 g/m2 if female
- LV wall thickness ≥12mm
- eGFR ≥30 ml/min/1.73m2 (CKD-EPI formula)
- Blood Potassium ≤5.5 mmol/L
- Not treated with MRAs and/or SGLT2i within the previous two weeks before inclusion and have no history of diabetic ketoacidosis while in treatment with SGLT2 inhibitors
- Stable/chronic ambulatory patients i.e., patients without need for hospitalization within the last 30 days due to heart failure decompensation episodes
- If female, she must be a woman of non-childbearing potential. That is, she must be:
- Surgically sterilized (e.g. underwent hysterectomy, bilateral salpingectomy or bilateral oophorectomy)
- Clinically diagnosed infertile
- In a post-menopausal state, defined as no menses for 12 months without an alternative medical cause.
- A female patient of childbearing potential must have a negative serum pregnancy test at Visit 1 (Day 0) and must agree to use consistently and correctly (from 28 days prior to first study treatment administration until at least 7 days after last study treatment administration) one of the following highly effective methods of contraception:
- Abstinence of heterosexual intercourse (when this is in line with preferred and usual lifestyle of the subject)
- Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable)
- Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal)
- Intrauterine device
- Intrauterine hormone-releasing system
- Bilateral tubal occlusion
- Vasectomized partner, who has received medical assessment of the surgical success, or clinically diagnosed infertile partner
Who cannot join
- Involvement in the planning and/or conduct of the study (applies to both Investigator staff and/or staff at the study site)
- Participation in another clinical study with an investigational product during the last month
- Unwilling to sign the informed consent form (if the patient wants to participate but cannot sign for any reason, then a third-person testimony may sign/complete informed consent form on patient's behalf)
- Major surgical procedure, coronary, cerebral or peripheral vascular events or sepsis in the prior 90 days
- Cancer (life-limiting or less than 2 years in remission)
- Any previously confirmed autoimmune disease
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- Type 1 Diabetes
- Ability to walk is, in the investigator's opinion, clearly limited by joint disease or other locomotor problems or lung diseases rather than by cardiorespiratory fitness
- Previously confirmed cardiac amyloidosis
- Severe valvulopathy according to the echocardiogram report
- Patients with a known hypersensitivity or intolerance to spironolactone or dapagliflozin or any of the excipients of the products.
- Female patients currently pregnant (confirmed by a positive pregnancy test) or intent to become pregnant or breast feeding.
Trial locations and contacts
2 sites in 1 country.
Portugal2 sites
Unidade Local de Saúde Gaia/Espinho
Porto, Gaia, 4434-502
Centro Hospitalar Universitário São João
Porto, 4200-319
About this study
Official title: SOdium-Glucose Cotransporter 2 Inhibitor With and Without an ALDosterone AntagonIst for Heart Failure With Preserved Ejection Fraction: a Two-centre Randomised Crossover Trial
Heart failure (HF) is a condition in which the heart does not contract ("pump") or relax well, leading to insufficient perfusion of vital organs. Ankle swelling, fatigue, and breathlessness are some of the features of this syndrome. There are different causes for HF (eg., infarct and hypertension) and two distinct types: HFrEF - HF with reduced ejection fraction - where the heart does not "pump" properly, and HFpEF - HF with preserved ejection fraction - the heart "pumps" but does not relax well. Treatment for HFrEF is better established than for HFpEF. In HFpEF, only mineralocorticoid receptors antagonists (MRAs) have been shown to reduce hospitalizations, circulating markers of cardiac dysfunction and fibrosis, and blood pressure. Sodium-glucose cotransporter-2 inhibitors (SGLT2i) are a therapeutic class that reduces morbidity and mortality in patients with high cardiovascular risk and diabetes and in patients with HFrEF with and without diabetes. Trials are underway to test whether SGLT2i may also be useful for the treatment of HFpEF. This work aims to compare the effects of SGLT2i alone and in combination in an MRA in patients with HFpEF.
- Being tested
- Dapagliflozin, Spironolactone + Dapagliflozin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DapagliflozinDrug
Also called Forxiga(R)
A: Dapagliflozin 10 mg once daily
Spironolactone + DapagliflozinDrug
Also called Forxiga(R) + Aldactone(R)
C: Dapagliflozin 10 mg once daily plus Spironolactone 25mg/every other day or 25mg/day (can be adjusted according to potassium and renal function)
| Study group | Role | What they receive |
|---|---|---|
| [Dapagliflozin] - [Dapagliflozin + Spironolactone] | Experimental | Drug will be administered according to sequence:
Dapagliflozin [week 1-12] - Dapagliflozin + Spironolactone [week 13-25] Receives: Drug: Dapagliflozin; Drug: Spironolactone + Dapagliflozin |
| [Dapagliflozin + Spironolactone] - [Dapagliflozin] | Experimental | Drug will be administered according to sequence:
Dapagliflozin + Spironolactone [week 1-12] - Dapagliflozin [week 13-25] Receives: Drug: Dapagliflozin; Drug: Spironolactone + Dapagliflozin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood levels of NT-pro BNP (Log transformed)
Comparison of NT-pro BNP levels between groups
Measured: Visit 1 Day 0 / Visit 2 Day 84 [Day 77 to Day 91] / Visit 3 Day 175 [Day 168 to Day 182]
Secondary outcomes (13)
Proportion of patients reaching a 20% or greater reduction in NT-proBNP levels
Measured in blood samples
Measured: Visit 1 Day 0 / Visit 2 Day 84 [Day 77 to Day 91] / Visit 3 Day 175 [Day 168 to Day 182]
Circulating levels of PICP, PIIINP and CITP
Measured in blood samples the circulating levels of procollagen type I carboxy-terminal propeptide (PICP), N-terminal propeptide of procollagen type III (PIIINP), C-terminal telopeptide of collagen type I (CITP)
Measured: Visit 1 Day 0 / Visit 2 Day 84 [Day 77 to Day 91] / Visit 3 Day 175 [Day 168 to Day 182]
Indexed Left Atrial Volume (LAVi)
Transthoracic echocardiogram
Measured: Visit 1 Day 0 / Visit 2 Day 84 [Day 77 to Day 91] / Visit 3 Day 175 [Day 168 to Day 182]
Left Ventricular Ejection Fraction (LVEF)
Transthoracic echocardiogram
Measured: Visit 1 Day 0 / Visit 2 Day 84 [Day 77 to Day 91] / Visit 3 Day 175 [Day 168 to Day 182]
Lateral E/e
Transthoracic echocardiogram
Measured: Visit 1 Day 0 / Visit 2 Day 84 [Day 77 to Day 91] / Visit 3 Day 175 [Day 168 to Day 182]
Indexed Left Ventricular Mass (LVMi)
Transthoracic echocardiogram
Measured: Visit 1 Day 0 / Visit 2 Day 84 [Day 77 to Day 91] / Visit 3 Day 175 [Day 168 to Day 182]
Pulmonary Artery Systolic Pressure (PASP)
Transthoracic echocardiogram
Measured: Visit 1 Day 0 / Visit 2 Day 84 [Day 77 to Day 91] / Visit 3 Day 175 [Day 168 to Day 182]
Systolic and Diastolic Blood Pressure (SBP/DBP)
Measure in the clinical appointment after 5min of seated rest. Mean of 3 automatic oscillometric measurements
Measured: Visit 1 Day 0 / Visit 2 Day 84 [Day 77 to Day 91] / Visit 3 Day 175 [Day 168 to Day 182]
Estimated glomerular filtration rate (eGFR)
Calculated from the serum creatinine using the 2021 CKD-EPI creatinine-based formula
Measured: Visit 1 Day 0 / Visit 2 Day 84 [Day 77 to Day 91] / Visit 3 Day 175 [Day 168 to Day 182]
Microalbuminuria (log-transformed)
Spot urine
Measured: Visit 1 Day 0 / Visit 2 Day 84 [Day 77 to Day 91] / Visit 3 Day 175 [Day 168 to Day 182]
Urinary sodium/natriuresis
Spot urine
Measured: Visit 1 Day 0 / Visit 2 Day 84 [Day 77 to Day 91] / Visit 3 Day 175 [Day 168 to Day 182]
Serum potassium (K+)
Concentration of potassium in the blood
Measured: Visit 1 Day 0 / Visit 2 Day 84 [Day 77 to Day 91] / Visit 3 Day 175 [Day 168 to Day 182]
Health-related quality of life (HR-QoL)
HR-QoL assessed by the Kansas City Cardiomyopathy Questionnaire a 23-item instrument. All items are measured on a Likert scale with 5-7 response options. KCCQ scores are scaled from 0 to 100 and summarized in 25-point ranges, where scores represent health status as follows: 0 to 24: very poor to poor; 25 to 49: poor to fair; 50 to 74: fair to good; and 75 to 100: good to excellent
Measured: Visit 1 Day 0 / Visit 2 Day 84 [Day 77 to Day 91] / Visit 3 Day 175 [Day 168 to Day 182]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2023
- Study start15 Sep 2022
- Primary completion29 Nov 2024
- Study completion29 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Heart Failure With Preserved Ejection FractionStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Prospective, randomised, open-label, two-treatment, two-period, cross-over trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade do Porto
- Sponsor type
- University, hospital or other
- Collaborators
- Centro Hospitalar De São João, E.P.E., Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.
- Responsible party
- Sponsor
- Investigators
- Adelino Leite-Moreira, MD, PhD, Principal investigator, Universidade do PortoRicardo Fontes-Carvalho, MD, PhD, Principal investigator, Unidade Local de Saúde Gaia/EspinhoJoão Ferreira, MD, PhD, Study director, Universidade do Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05676684
- Sponsor's protocol ID
- SOGALDI-PEF
- Acronym
- SOGALDI-PEF
- Status last verified
- Mar 2025
- First submitted
- 6 Dec 2022
- Last updated
- 17 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ferreira JP, Marques P, Neves JS, Leite AR, Teixeira C, Saraiva F, Sharma A, Zannad F, Pimenta J, Fontes-Carvalho R, Leite-Moreira A, Vasques-Novoa F; SOGALDI-PEF Investigators. Renin, Aldosterone, and Treatment Response to Dapagliflozin, Spironolactone, and Their Combination: An Analysis From SOGALDI-PEF. JACC Heart Fail. 2026 May 22:103111. doi: 10.1016/j.jchf.2026.103111. Online ahead of print.
PubMed 42201301Ferreira JP, Vasques-Novoa F, Saraiva F, Oliveira AC, Almeida J, Batista AB, Barbosa A, Ferreira AF, Costa C, Diaz SO, Santos-Ferreira D, Frioes F, Goncalves C, Guimaraes JT, Leite M, Marques P, Mascarenhas J, Matos MI, Pereira C, Rodrigues P, Sharma A, Silva G, Pereira-Sousa I, Sousa C, Zannad F, Pimenta J, Fontes-Carvalho R, Leite-Moreira A. Sodium-Glucose Cotransporter 2 Inhibitor With and Without an Aldosterone Antagonist for Heart Failure With Preserved Ejection Fraction: The SOGALDI-PEF Trial. J Am Coll Cardiol. 2025 Aug 5;86(5):320-333. doi: 10.1016/j.jacc.2025.05.033.
PubMed 40738559
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SOdium-Glucose Cotransporter 2 Inhibitor With and Without an ALDosterone AntagonIst for Heart Failure With Preserved Ejection Fraction: a Two-centre Randomised Crossover Trial
- ClinicalTrials.gov ID
- NCT05676684
- Acronym / sponsor ID
- SOGALDI-PEF / SOGALDI-PEF
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Universidade do PortoUniversity, hospital or other
- Collaborators
- Centro Hospitalar De São João, E.P.E., Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.
- Study start
- 15 Sep 2022 (actual)
- Primary completion
- 29 Nov 2024 (actual)
- Study completion
- 29 Nov 2024 (actual)
- First posted
- 9 Jan 2023 (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.
Heart failure (HF) is a condition in which the heart does not contract ("pump") or relax well, leading to insufficient perfusion of vital organs. Ankle swelling, fatigue, and breathlessness are some of the features of this syndrome. There are different causes for HF (eg., infarct and hypertension) and two distinct types: HFrEF - HF with reduced ejection fraction - where the heart does not "pump" properly, and HFpEF - HF with preserved ejection fraction - the heart "pumps" but does not relax well. Treatment for HFrEF is better established than for HFpEF. In HFpEF, only mineralocorticoid receptors antagonists (MRAs) have been shown to reduce hospitalizations, circulating markers of cardiac dysfunction and fibrosis, and blood pressure. Sodium-glucose cotransporter-2 inhibitors (SGLT2i) are a therapeutic class that reduces morbidity and mortality in patients with high cardiovascular risk and diabetes and in patients with HFrEF with and without diabetes. Trials are underway to test whether SGLT2i may also be useful for the treatment of HFpEF. This work aims to compare the effects of SGLT2i alone and in combination in an MRA in patients with HFpEF.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, randomised, open-label, two-treatment, two-period, cross-over trial
| Arm | Type | Receives |
|---|---|---|
| [Dapagliflozin] - [Dapagliflozin + Spironolactone] | Experimental | Drug: Dapagliflozin, Drug: Spironolactone + DapagliflozinDrug will be administered according to sequence: Dapagliflozin [week 1-12] - Dapagliflozin + Spironolactone [week 13-25] |
| [Dapagliflozin + Spironolactone] - [Dapagliflozin] | Experimental | Drug: Dapagliflozin, Drug: Spironolactone + DapagliflozinDrug will be administered according to sequence: Dapagliflozin + Spironolactone [week 1-12] - Dapagliflozin [week 13-25] |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (28 listed)
- Provision of informed consent prior to any study specific procedures
- HFpEF diagnosis* (irrespective of time since diagnosis)
- Male or female patients, aged ≥50 years
- NYHA Class II-IV
- LVEF > 40%
Key exclusion criteria (12 listed)
- Involvement in the planning and/or conduct of the study (applies to both Investigator staff and/or staff at the study site)
- Participation in another clinical study with an investigational product during the last month
- Unwilling to sign the informed consent form (if the patient wants to participate but cannot sign for any reason, then a third-person testimony may sign/complete informed consent form on patient's behalf)
- Major surgical procedure, coronary, cerebral or peripheral vascular events or sepsis in the prior 90 days
- Cancer (life-limiting or less than 2 years in remission)
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 |
|---|---|---|
| DapagliflozinAlso: Forxiga(R)A: Dapagliflozin 10 mg once daily | Drug | [Dapagliflozin + Spironolactone] - [Dapagliflozin], [Dapagliflozin] - [Dapagliflozin + Spironolactone] |
| Spironolactone + DapagliflozinAlso: Forxiga(R) + Aldactone(R)C: Dapagliflozin 10 mg once daily plus Spironolactone 25mg/every other day or 25mg/day (can be adjusted according to potassium and renal function) | Drug | [Dapagliflozin + Spironolactone] - [Dapagliflozin], [Dapagliflozin] - [Dapagliflozin + Spironolactone] |
Primary outcome
Blood levels of NT-pro BNP (Log transformed)
Time frame: Visit 1 Day 0 / Visit 2 Day 84 [Day 77 to Day 91] / Visit 3 Day 175 [Day 168 to Day 182]
Comparison of NT-pro BNP levels between groups
13 secondary outcomes
Proportion of patients reaching a 20% or greater reduction in NT-proBNP levels
Time frame: Visit 1 Day 0 / Visit 2 Day 84 [Day 77 to Day 91] / Visit 3 Day 175 [Day 168 to Day 182]
Circulating levels of PICP, PIIINP and CITP
Time frame: Visit 1 Day 0 / Visit 2 Day 84 [Day 77 to Day 91] / Visit 3 Day 175 [Day 168 to Day 182]
Indexed Left Atrial Volume (LAVi)
Time frame: Visit 1 Day 0 / Visit 2 Day 84 [Day 77 to Day 91] / Visit 3 Day 175 [Day 168 to Day 182]
Left Ventricular Ejection Fraction (LVEF)
Time frame: Visit 1 Day 0 / Visit 2 Day 84 [Day 77 to Day 91] / Visit 3 Day 175 [Day 168 to Day 182]
Lateral E/e
Time frame: Visit 1 Day 0 / Visit 2 Day 84 [Day 77 to Day 91] / Visit 3 Day 175 [Day 168 to Day 182]
Indexed Left Ventricular Mass (LVMi)
Time frame: Visit 1 Day 0 / Visit 2 Day 84 [Day 77 to Day 91] / Visit 3 Day 175 [Day 168 to Day 182]
Pulmonary Artery Systolic Pressure (PASP)
Time frame: Visit 1 Day 0 / Visit 2 Day 84 [Day 77 to Day 91] / Visit 3 Day 175 [Day 168 to Day 182]
Systolic and Diastolic Blood Pressure (SBP/DBP)
Time frame: Visit 1 Day 0 / Visit 2 Day 84 [Day 77 to Day 91] / Visit 3 Day 175 [Day 168 to Day 182]
Estimated glomerular filtration rate (eGFR)
Time frame: Visit 1 Day 0 / Visit 2 Day 84 [Day 77 to Day 91] / Visit 3 Day 175 [Day 168 to Day 182]
Microalbuminuria (log-transformed)
Time frame: Visit 1 Day 0 / Visit 2 Day 84 [Day 77 to Day 91] / Visit 3 Day 175 [Day 168 to Day 182]
Urinary sodium/natriuresis
Time frame: Visit 1 Day 0 / Visit 2 Day 84 [Day 77 to Day 91] / Visit 3 Day 175 [Day 168 to Day 182]
Serum potassium (K+)
Time frame: Visit 1 Day 0 / Visit 2 Day 84 [Day 77 to Day 91] / Visit 3 Day 175 [Day 168 to Day 182]
Health-related quality of life (HR-QoL)
Time frame: Visit 1 Day 0 / Visit 2 Day 84 [Day 77 to Day 91] / Visit 3 Day 175 [Day 168 to Day 182]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2025.
- Derived from this study: PubMed 42201301Ferreira JP, Marques P, Neves JS, Leite AR, Teixeira C, Saraiva F, Sharma A, Zannad F, Pimenta J, Fontes-Carvalho R, Leite-Moreira A, Vasques-Novoa F; SOGALDI-PEF Investigators. Renin, Aldosterone, and Treatment Response to Dapagliflozin, Spironolactone, and Their Combination: An Analysis From SOGALDI-PEF. JACC Heart Fail. 2026 May 22:103111. doi: 10.1016/j.jchf.2026.103111. Online ahead of print.
- Derived from this study: PubMed 40738559Ferreira JP, Vasques-Novoa F, Saraiva F, Oliveira AC, Almeida J, Batista AB, Barbosa A, Ferreira AF, Costa C, Diaz SO, Santos-Ferreira D, Frioes F, Goncalves C, Guimaraes JT, Leite M, Marques P, Mascarenhas J, Matos MI, Pereira C, Rodrigues P, Sharma A, Silva G, Pereira-Sousa I, Sousa C, Zannad F, Pimenta J, Fontes-Carvalho R, Leite-Moreira A. Sodium-Glucose Cotransporter 2 Inhibitor With and Without an Aldosterone Antagonist for Heart Failure With Preserved Ejection Fraction: The SOGALDI-PEF Trial. J Am Coll Cardiol. 2025 Aug 5;86(5):320-333. doi: 10.1016/j.jacc.2025.05.033.
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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.
Adelino Leite-Moreira, MD, PhD principal investigator
Universidade do Porto
Ricardo Fontes-Carvalho, MD, PhD principal investigator
Unidade Local de Saúde Gaia/Espinho
João Ferreira, MD, PhD study director
Universidade do Porto
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Dapagliflozin and Spironolactone + Dapagliflozin in people with Heart Failure With Preserved Ejection Fraction, run by Universidade do Porto at 2 sites in Portugal.
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 28 inclusion and 12 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: finished, as of the sponsor's last update on 17 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Portugal. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood levels of NT-pro BNP (Log transformed) (time frame: Visit 1 Day 0 / Visit 2 Day 84 [Day 77 to Day 91] / Visit 3 Day 175 [Day 168 to Day 182]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05676684, which also lists 2 linked publications.
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 17 Aug 2025.