Heart FailurePhase 2HomageNCT02556450
Bioprofiling Response to Mineralocorticoid Receptor Antagonists for the Prevention of Heart Failure
A Phase 2 study testing Spironolacton in people with Heart Failure, run by ACS Biomarker at 9 sites in 6 countries.
Trial summary
Despite advances in care, prognosis remains poor once overt Heart Failure (HF) has developed. Prevention is most efficient when directed toward patients at risk and when mechanistically targeted to patients most likely to respond. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Spironolacton
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 528 participants
- Where
- 9 sitesin 6 countries
- Study dates
- Jan 2016to 31 Jan 2019
- Phase
- Phase 2
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent will be obtained prior to any study procedure;
- Age >60 years
- Clinical risk factors for developing heart failure, either:
- Coronary artery disease (h/o myocardial infarction, angioplasty or coronary artery bypass) Or
- At least two of the following:
- Diabetes Mellitus requiring Hypoglycaemic Pharmacotherapy
Show all 10Show fewer
- Receiving pharmacological treatment for Hypertension
- Microalbuminuria
- Abnormal ECG (left ventricular hypertrophy, QRS >120msec, abnormal Q-waves)
- Biological risk: NT-pro-BNP values between 125 and 1,000 ng/L or BNP values between 35 and 280 pg/ml (consistent with ESC guidelines indicating risk of HF but helping to rule out prevalent HF or atrial fibrillation which are associated with marked increases in NT-proBNP/BNP and should be investigated)
Who cannot join
- Recent wound healing/inflammation:
- Surgical procedure, coronary, cerebral or peripheral vascular events or infection in the prior 3 months
- Cancer
- Autoimmune disease
- Hepatic Disease
- Pre-existing diagnosis of clinical HF
Show all 18Show fewer
- Moderate/severe LV systolic ventricular dysfunction, i.e. LVEF <45%
- Moderate or severe valve disease (investigators opinion)
- eGFR< 30ml/min
- Serum potassium >5.0 mmol/L
- Treatment with an MRA or a loop diuretic (furosemide, bumetanide, ethacrynic acid or torasemide) in the previous three months
- Potassium supplements or potassium-sparing diuretic at time of enrolment.
- Atrial fibrillation within one month prior to inclusion (AF lasting <60 seconds on ambulatory ECG monitoring is permitted)
- •. History of hypersensitivity to spironolactone.
- Requiring treatment with prohibited medication according to SmPC with exception of ACE inhibitors or angiotensin receptor blockers
- Patients unable to give written informed consent.
- Participation in another interventional trial in the preceding month
- Ability to walk is, in the investigators opinion, clearly limited by joint disease or other locomotor problems rather than by cardiorespiratory fitness
Trial locations and contacts
9 sites in 6 countries.
9 sites in 6 countries
United Kingdom3 sites
Queen Elizabeth University Hospital
Glasgow, G51 4TF
Castle Hill Hospital
Hull, HU16 5JQ
Central Manchester University Hospitals NHS
Manchester, M13 9WL
France2 sites
Hopital Sud Francilien
Corbeil-Essonnes, 91106
CHU de Nancy
Nancy, 54500
About this study
Official title: Bioprofiling Response to Mineralocorticoid Receptor Antagonists for the Prevention of Heart Failure. A Proof of Concept Clinical Trial Within the EU FP 7 (European Union FP7) "HOMAGE" Programme " Heart OMics in AGing "
Despite advances in care, prognosis remains poor once overt Heart Failure (HF) has developed. Prevention is most efficient when directed toward patients at risk and when mechanistically targeted to patients most likely to respond. An increase in myocardial and possibly vascular collagen content (fibrosis) may be a major determinant of the transition to HF. In patients with hypertension and diabetes, two important risk-factors for HF, changes in blood markers of fibrosis occur before clinically overt HF develops. These markers are also related to prognosis.
In the general population, Galectin-3 (Gal-3), a potential marker of fibrosis, is associated with cardiovascular (CV) risk factors, and predicts development of HF. In animal models, Gal-3 is a key mediator of aldosterone-induced CV and renal fibrosis and dysfunction.
Read more
The investigators hypothesize that the mineralocorticoid receptor antagonist (MRA), spironolactone, may prevent HF by acting on extracellular matrix remodelling, especially in patients with active fibrogenesis, identified by high Gal-3 levels. The benefit/risk ratio of spironolactone might be superior in patients with a higher compared to lower plasma concentrations of Gal-3.
Main objective is to investigate whether spironolactone can favourably alter extra-cellular matrix remodelling, assessed by changes in the fibrosis biomarker Procollagen Type III N-Terminal Peptide (PIIINP), in patients at increased risk of developing heart failure and whether this effect is greater in patients with increased plasma concentrations of Gal-3.
Read the detailed description
The investigators hypothesize that the mineralocorticoid receptor antagonist (MRA), spironolactone, may prevent HF by acting on extracellular matrix remodelling, especially in patients with active fibrogenesis, identified by high Gal-3 levels. The benefit/risk ratio of spironolactone might be superior in patients with a higher compared to lower plasma concentrations of Gal-3.
- Conditions
- Heart Failure
- Being tested
- Spironolacton
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpironolactonDrug
Also called Spironolacton Sandoz
Administration of Spironolacton 25 mg per day
| Study group | Role | What they receive |
|---|---|---|
| Spironolacton Group | Experimental | Spironolacton Sandoz given 25mg daily oral use Receives: Drug: Spironolacton |
| Control group | No intervention | Only background treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in serum concentrations of PIIINP
mmol/l
Measured: 9 months
Secondary outcomes (10)
changes in serum plasma levels of Biomarkers
PICP (synthesis), ICTP (degradation) and GAL3
Measured: 9 months
Cardiac remodelling 1
NT-proBNP (ELISA, central Lab), from baseline to 9 months (Certified centers and central readings).
Measured: 9 months
Cardiac remodelling 2
Left Ventricular Mass (g/m)
Measured: 9 months
Cardiac remodelling 3
Left Atrial Volume (ml)
Measured: 9 months
Cardiorespiratory performance during exercise
Shuttle walk test: Distance walked in meters
Measured: baseline, 9 months
Vascular function
non-invasive technologies: BP lab Audicor system
Measured: screening, baseline, month1, month3, month 6, month 9
heart failure or AF
Rate of the clinical composite of development of heart failure or atrial fibrillation, non-fatal myocardial infarction or stroke or CV death from baseline to 9 months. The HOMAGE blinded clinical event committee will adjudicate all serious adverse events.
Measured: 9 months
Adverse events
All adverse events
Measured: screening, baseline, month1, month3, month 6, month 9
Worsening renal function
decline in eGFR >20%
Measured: screening, baseline, month1, month3, month 6, month 9
Hyperkalemia
rise of serum potassium to >5.5 mmol/L
Measured: screening, baseline, month1, month3, month 6, month 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2015 (estimated)
- Study startJan 2016
- Primary completion30 Sep 2018
- Study completion31 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 528 participants (actual)
Sponsor and investigators
- Lead sponsor
- ACS Biomarker
- Sponsor type
- University, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, London School of Hygiene and Tropical Medicine
- Responsible party
- Sponsor
- Investigators
- John Cleland, PhD, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02556450
- Sponsor's protocol ID
- Homage
- Acronym
- Homage
- Status last verified
- Mar 2022
- First submitted
- 8 Sep 2015
- Last updated
- 8 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ferreira JP, Zannad F. Screening for Undiagnosed Heart Failure: A Viewpoint. J Card Fail. 2025 Aug;31(8):1339-1344. doi: 10.1016/j.cardfail.2025.04.016. Epub 2025 May 23.
PubMed 40414280Yu YL, Siwy J, An DW, Gonzalez A, Hansen T, Latosinska A, Pellicori P, Ravassa S, Mariottoni B, Verdonschot JA, Ahmed F, Petutschnigg J, Rossignol P, Heymans S, Cuthbert JJ, Girerd N, Clark AL, Verhamme P, Nawrot TS, Janssens S, Cleland JG, Zannad F, Diez J, Mischak H, Ferreira JP, Staessen JA; HOMAGE investigators. Urinary proteomic signature of mineralocorticoid receptor antagonism by spironolactone: evidence from the HOMAGE trial. Heart. 2024 Sep 16;110(19):1180-1187. doi: 10.1136/heartjnl-2023-323796.
PubMed 38729636Monzo L, Ferreira JP, Cleland JGF, Pellicori P, Mariottoni B, Verdonschot JAJ, Hazebroek MR, Collier TJ, Cuthbert JJ, Pieske B, Edelmann F, Petutschnigg J, Khan J, Ahmed FZ, Girerd N, Bozec E, Diez J, Gonzalez A, Clark AL, Cosmi F, Staessen JA, Heymans S, Rossignol P, Zannad F. Dyskalemia in people at increased risk for heart failure: findings from the heart 'OMics' in AGEing (HOMAGE) trial. ESC Heart Fail. 2022 Dec;9(6):4352-4357. doi: 10.1002/ehf2.14086. Epub 2022 Sep 6.
PubMed 36065795Verdonschot JAJ, Ferreira JP, Pizard A, Pellicori P, Brunner La Rocca HP, Clark AL, Cosmi F, Cuthbert J, Girerd N, Waring OJ, Henkens MHTM, Mariottoni B, Petutschnigg J, Rossignol P, Hazebroek MR, Cleland JGF, Zannad F, Heymans SRB; HOMAGE "Heart Omics in AGEing" Consortium. The Effect of Spironolactone in Patients With Obesity at Risk for Heart Failure: Proteomic Insights from the HOMAGE Trial. J Card Fail. 2022 May;28(5):778-786. doi: 10.1016/j.cardfail.2021.12.005. Epub 2021 Dec 18.
PubMed 34933097Verdonschot JAJ, Ferreira JP, Pellicori P, Brunner-La Rocca HP, Clark AL, Cosmi F, Cuthbert J, Girerd N, Mariottoni B, Petutschnigg J, Rossignol P, Cleland JGF, Zannad F, Heymans SRB; HOMAGE "Heart Omics in AGEing" consortium. Proteomic mechanistic profile of patients with diabetes at risk of developing heart failure: insights from the HOMAGE trial. Cardiovasc Diabetol. 2021 Aug 9;20(1):163. doi: 10.1186/s12933-021-01357-9.
PubMed 34372849Ferreira JP, Verdonschot J, Wang P, Pizard A, Collier T, Ahmed FZ, Brunner-La-Rocca HP, Clark AL, Cosmi F, Cuthbert J, Diez J, Edelmann F, Girerd N, Gonzalez A, Grojean S, Hazebroek M, Khan J, Latini R, Mamas MA, Mariottoni B, Mujaj B, Pellicori P, Petutschnigg J, Pieske B, Rossignol P, Rouet P, Staessen JA, Cleland JGF, Heymans S, Zannad F; HOMAGE (Heart Omics in AGEing) Consortium. Proteomic and Mechanistic Analysis of Spironolactone in Patients at Risk for HF. JACC Heart Fail. 2021 Apr;9(4):268-277. doi: 10.1016/j.jchf.2020.11.010. Epub 2021 Feb 3.
PubMed 33549556Pellicori P, Ferreira JP, Mariottoni B, Brunner-La Rocca HP, Ahmed FZ, Verdonschot J, Collier T, Cuthbert JJ, Petutschnigg J, Mujaj B, Girerd N, Gonzalez A, Clark AL, Cosmi F, Staessen JA, Heymans S, Latini R, Rossignol P, Zannad F, Cleland JGF. Effects of spironolactone on serum markers of fibrosis in people at high risk of developing heart failure: rationale, design and baseline characteristics of a proof-of-concept, randomised, precision-medicine, prevention trial. The Heart OMics in AGing (HOMAGE) trial. Eur J Heart Fail. 2020 Sep;22(9):1711-1723. doi: 10.1002/ejhf.1716. Epub 2020 Jan 16.
PubMed 31950604Ferreira JP, Verdonschot J, Collier T, Wang P, Pizard A, Bar C, Bjorkman J, Boccanelli A, Butler J, Clark A, Cleland JG, Delles C, Diez J, Girerd N, Gonzalez A, Hazebroek M, Huby AC, Jukema W, Latini R, Leenders J, Levy D, Mebazaa A, Mischak H, Pinet F, Rossignol P, Sattar N, Sever P, Staessen JA, Thum T, Vodovar N, Zhang ZY, Heymans S, Zannad F. Proteomic Bioprofiles and Mechanistic Pathways of Progression to Heart Failure. Circ Heart Fail. 2019 May;12(5):e005897. doi: 10.1161/CIRCHEARTFAILURE.118.005897.
PubMed 31104495
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioprofiling Response to Mineralocorticoid Receptor Antagonists for the Prevention of Heart Failure. A Proof of Concept Clinical Trial Within the EU FP 7 (European Union FP7) "HOMAGE" Programme " Heart OMics in AGing "
- ClinicalTrials.gov ID
- NCT02556450
- Acronym / sponsor ID
- Homage / Homage
- Conditions
- Heart Failure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 528 participants (actual)
- Lead sponsor
- ACS BiomarkerUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, London School of Hygiene and Tropical Medicine
- Study start
- Jan 2016
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 22 Sep 2015 (estimated)
- 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.
Despite advances in care, prognosis remains poor once overt Heart Failure (HF) has developed. Prevention is most efficient when directed toward patients at risk and when mechanistically targeted to patients most likely to respond. An increase in myocardial and possibly vascular collagen content (fibrosis) may be a major determinant of the transition to HF. In patients with hypertension and diabetes, two important risk-factors for HF, changes in blood markers of fibrosis occur before clinically overt HF develops. These markers are also related to prognosis.
In the general population, Galectin-3 (Gal-3), a potential marker of fibrosis, is associated with cardiovascular (CV) risk factors, and predicts development of HF. In animal models, Gal-3 is a key mediator of aldosterone-induced CV and renal fibrosis and dysfunction.
The investigators hypothesize that the mineralocorticoid receptor antagonist (MRA), spironolactone, may prevent HF by acting on extracellular matrix remodelling, especially in patients with active fibrogenesis, identified by high Gal-3 levels. The benefit/risk ratio of spironolactone might be superior in patients with a higher compared to lower plasma concentrations of Gal-3.
Main objective is to investigate whether spironolactone can favourably alter extra-cellular matrix remodelling, assessed by changes in the fibrosis biomarker Procollagen Type III N-Terminal Peptide (PIIINP), in patients at increased risk of developing heart failure and whether this effect is greater in patients with increased plasma concentrations of Gal-3.
Detailed description
The investigators hypothesize that the mineralocorticoid receptor antagonist (MRA), spironolactone, may prevent HF by acting on extracellular matrix remodelling, especially in patients with active fibrogenesis, identified by high Gal-3 levels. The benefit/risk ratio of spironolactone might be superior in patients with a higher compared to lower plasma concentrations of Gal-3.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spironolacton Group | Experimental | Drug: SpironolactonSpironolacton Sandoz given 25mg daily oral use |
| Control group | No intervention | –Only background treatment |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Written informed consent will be obtained prior to any study procedure;
- Age >60 years
- Clinical risk factors for developing heart failure, either:
- Biological risk: NT-pro-BNP values between 125 and 1,000 ng/L or BNP values between 35 and 280 pg/ml (consistent with ESC guidelines indicating risk of HF but helping to rule out prevalent HF or atrial fibrillation which are associated with marked increases in NT-proBNP/BNP and should be investigated)
Key exclusion criteria (18 listed)
- Recent wound healing/inflammation:
- Surgical procedure, coronary, cerebral or peripheral vascular events or infection in the prior 3 months
- Cancer
- Autoimmune disease
- Hepatic Disease
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 |
|---|---|---|
| SpironolactonAlso: Spironolacton SandozAdministration of Spironolacton 25 mg per day | Drug | Spironolacton Group |
Primary outcome
Changes in serum concentrations of PIIINP
Time frame: 9 months
mmol/l
10 secondary outcomes
changes in serum plasma levels of Biomarkers
Time frame: 9 months
Cardiac remodelling 1
Time frame: 9 months
Cardiac remodelling 2
Time frame: 9 months
Cardiac remodelling 3
Time frame: 9 months
Cardiorespiratory performance during exercise
Time frame: baseline, 9 months
Vascular function
Time frame: screening, baseline, month1, month3, month 6, month 9
heart failure or AF
Time frame: 9 months
Adverse events
Time frame: screening, baseline, month1, month3, month 6, month 9
Worsening renal function
Time frame: screening, baseline, month1, month3, month 6, month 9
Hyperkalemia
Time frame: screening, baseline, month1, month3, month 6, month 9
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 8 Mar 2022.
- Derived from this study: PubMed 40414280Ferreira JP, Zannad F. Screening for Undiagnosed Heart Failure: A Viewpoint. J Card Fail. 2025 Aug;31(8):1339-1344. doi: 10.1016/j.cardfail.2025.04.016. Epub 2025 May 23.
- Derived from this study: PubMed 38729636Yu YL, Siwy J, An DW, Gonzalez A, Hansen T, Latosinska A, Pellicori P, Ravassa S, Mariottoni B, Verdonschot JA, Ahmed F, Petutschnigg J, Rossignol P, Heymans S, Cuthbert JJ, Girerd N, Clark AL, Verhamme P, Nawrot TS, Janssens S, Cleland JG, Zannad F, Diez J, Mischak H, Ferreira JP, Staessen JA; HOMAGE investigators. Urinary proteomic signature of mineralocorticoid receptor antagonism by spironolactone: evidence from the HOMAGE trial. Heart. 2024 Sep 16;110(19):1180-1187. doi: 10.1136/heartjnl-2023-323796.
- Derived from this study: PubMed 36065795Monzo L, Ferreira JP, Cleland JGF, Pellicori P, Mariottoni B, Verdonschot JAJ, Hazebroek MR, Collier TJ, Cuthbert JJ, Pieske B, Edelmann F, Petutschnigg J, Khan J, Ahmed FZ, Girerd N, Bozec E, Diez J, Gonzalez A, Clark AL, Cosmi F, Staessen JA, Heymans S, Rossignol P, Zannad F. Dyskalemia in people at increased risk for heart failure: findings from the heart 'OMics' in AGEing (HOMAGE) trial. ESC Heart Fail. 2022 Dec;9(6):4352-4357. doi: 10.1002/ehf2.14086. Epub 2022 Sep 6.
- Derived from this study: PubMed 34933097Verdonschot JAJ, Ferreira JP, Pizard A, Pellicori P, Brunner La Rocca HP, Clark AL, Cosmi F, Cuthbert J, Girerd N, Waring OJ, Henkens MHTM, Mariottoni B, Petutschnigg J, Rossignol P, Hazebroek MR, Cleland JGF, Zannad F, Heymans SRB; HOMAGE "Heart Omics in AGEing" Consortium. The Effect of Spironolactone in Patients With Obesity at Risk for Heart Failure: Proteomic Insights from the HOMAGE Trial. J Card Fail. 2022 May;28(5):778-786. doi: 10.1016/j.cardfail.2021.12.005. Epub 2021 Dec 18.
- Derived from this study: PubMed 34372849Verdonschot JAJ, Ferreira JP, Pellicori P, Brunner-La Rocca HP, Clark AL, Cosmi F, Cuthbert J, Girerd N, Mariottoni B, Petutschnigg J, Rossignol P, Cleland JGF, Zannad F, Heymans SRB; HOMAGE "Heart Omics in AGEing" consortium. Proteomic mechanistic profile of patients with diabetes at risk of developing heart failure: insights from the HOMAGE trial. Cardiovasc Diabetol. 2021 Aug 9;20(1):163. doi: 10.1186/s12933-021-01357-9.
- Derived from this study: PubMed 33549556Ferreira JP, Verdonschot J, Wang P, Pizard A, Collier T, Ahmed FZ, Brunner-La-Rocca HP, Clark AL, Cosmi F, Cuthbert J, Diez J, Edelmann F, Girerd N, Gonzalez A, Grojean S, Hazebroek M, Khan J, Latini R, Mamas MA, Mariottoni B, Mujaj B, Pellicori P, Petutschnigg J, Pieske B, Rossignol P, Rouet P, Staessen JA, Cleland JGF, Heymans S, Zannad F; HOMAGE (Heart Omics in AGEing) Consortium. Proteomic and Mechanistic Analysis of Spironolactone in Patients at Risk for HF. JACC Heart Fail. 2021 Apr;9(4):268-277. doi: 10.1016/j.jchf.2020.11.010. Epub 2021 Feb 3.
- Derived from this study: PubMed 31950604Pellicori P, Ferreira JP, Mariottoni B, Brunner-La Rocca HP, Ahmed FZ, Verdonschot J, Collier T, Cuthbert JJ, Petutschnigg J, Mujaj B, Girerd N, Gonzalez A, Clark AL, Cosmi F, Staessen JA, Heymans S, Latini R, Rossignol P, Zannad F, Cleland JGF. Effects of spironolactone on serum markers of fibrosis in people at high risk of developing heart failure: rationale, design and baseline characteristics of a proof-of-concept, randomised, precision-medicine, prevention trial. The Heart OMics in AGing (HOMAGE) trial. Eur J Heart Fail. 2020 Sep;22(9):1711-1723. doi: 10.1002/ejhf.1716. Epub 2020 Jan 16.
- Derived from this study: PubMed 31104495Ferreira JP, Verdonschot J, Collier T, Wang P, Pizard A, Bar C, Bjorkman J, Boccanelli A, Butler J, Clark A, Cleland JG, Delles C, Diez J, Girerd N, Gonzalez A, Hazebroek M, Huby AC, Jukema W, Latini R, Leenders J, Levy D, Mebazaa A, Mischak H, Pinet F, Rossignol P, Sattar N, Sever P, Staessen JA, Thum T, Vodovar N, Zhang ZY, Heymans S, Zannad F. Proteomic Bioprofiles and Mechanistic Pathways of Progression to Heart Failure. Circ Heart Fail. 2019 May;12(5):e005897. doi: 10.1161/CIRCHEARTFAILURE.118.005897.
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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.
John Cleland, PhD principal investigator
Imperial College London
9 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Spironolacton in people with Heart Failure, run by ACS Biomarker at 9 sites in 6 countries.
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 10 inclusion and 18 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 8 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United Kingdom, France, Germany, Ireland, Italy and 1 more country. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Changes in serum concentrations of PIIINP (time frame: 9 months). 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 NCT02556450, which also lists 8 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 8 Mar 2022.