Heart FailurePhase 2QUID-HFNCT02780180
QUantum Genomics Incremental Dosing in Heart Failure - QUID-HF
A Phase 2 study testing QGC001 in people with Heart Failure, run by Quantum Genomics SA at 23 sites in 8 countries.
Trial summary
Heart Failure (HF) a common clinical condition characterized by either by a heart that does not pump sufficiently or becomes stiff. A variety of mechanisms contribute to progressive cardiac remodeling and dysfunction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- QGC001
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 23 sitesin 8 countries
- Study dates
- Jun 2016to 12 Sep 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A signed and dated informed consent form prior to any study procedure
- Adult male subjects and female subjects without childbearing potential.
- Clinical diagnosis of CHF with history of NYHA class II-III for at least 3 months before randomisation.
- Documented left ventricular ejection fraction (LVEF) < 40% measured by any modality within the previous 12 months in the subject's medical history.
- Subjects must also have at least one local measurement of BNP level ≥ 300 pg/mL or NT-proBNP level ≥ 1200 pg/mL (preferred assay, local laboratory) at the screening visit (maximum 7 days before randomisation).
- eGFR > 30 mL/min/1.73 m2 (MDRD) at screening.
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- Serum potassium < 5.0 mmol/L at screening.
- Systolic blood pressure < 110 mmHg (average of 3 consecutive measurements) at screening.
- Prescribed to optimal pharmacologic therapy per "ESC guidelines for the diagnosis and treatment of acute and chronic heart failure 2016", or based on the updated current clinical practice, unless contra-indicated or not-tolerated, and on a stable dose for at least 30 days prior to enrolment (the dosage of the drugs cannot be increased or decreased respectively by more than double or half of initial dosage).
- Taking oral loop diuretics at doses < 250 mg furosemide daily (or equivalent).
Who cannot join
- BMI > 45 kg.m-2.
- Patients who require the use of HF IV therapy or oral furosemide > 250 mg (or equivalent) at any time during the 48 hours immediately before randomisation.
- Patients with unstable angina, myocardial infarction, PTCA, coronary artery bypass graft, cerebral vascular accident, or transient ischemic attack within previous 3 months (90 days) before enrolment.
- Patients whose primary cause of heart failure is mitral or aortic valve disease or congenital heart disease or hypertrophic obstructive cardiomyopathy or infiltrative cardiomyopathy (e.g. amyloidosis, sarcoidosis) or myocarditis.
- Patients with "new" permanent atrial fibrillation (AF), discovered within 3 months prior to randomization.
- Heart rate > 110 beats/min at screening.
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- Patients scheduled for Pacemaker (including ICD, CRT), Angioplasty, CABG or LVAD within the next 3 months.
- Patients with severe documented chronic obstructive lung disease (COPD), defined as chronic need for oxygen therapy
- eGFR < 30 mL/min/1.73 m2 (MDRD) at screening.
- Decrease in eGFR greater than 20% within 3 weeks prior to the screening visit.
- Serum potassium > 5.0 mmol/L at screening.
- Systolic blood pressure < 110 mmHg or with signs or symptoms of hypotension.
- Symptomatic hypotension or orthostatic hypotension defined by a decrease of systolic blood pressure of more than 30 mm Hg in the standing vs. sitting position at screening and at the basal SBP of the D0 (before having taken the study medication).
- A marked baseline prolongation of QT/QTc interval (e.g. repeated demonstrated of a QTc interval > 450 ms) AND QRS < 100 ms. In case of QRS enlargement > 100 ms (i-e bundle branch block, pacemakers) QT does not accurately reflect repolarization and may not be calculated.
- A history of additional risk factors for Torsade de Pointes (TdP) (e.g. hypokalemia, family history of long QT Syndrome).
- The use of concomitant medications that prolong the QT/QTc interval.
- Insulin-requiring diabetic patients (including type 1 Diabetes).
- History of angioneurotic edema.
- Severe liver failure at screening defined by a value of ALAT and/or ASAT≥ 5 from the normal value.
- Patients involved in any interventional clinical study, patients enrolled in Registries and/or in non-interventional studies may participate.
- Patients who take an investigational or non-approved treatment.
- Women of childbearing potential.
- Patients with a prior cardiac transplant or patients currently on the list for cardiac transplantation.
- Patient with hypersensitivity to the active substance or to one of the other components of the trial preparation.
- Patients in whom an allergy requiring chronic treatment is known or exists.
- Patients with a history of previous illnesses of neurological or psychiatric nature that affect the Central Nervous System.
- Patients with a life expectancy of less than 12 months per physician judgment.
- Frail patient who, in the opinion of the investigator will not be able to follow the protocol.
Trial locations and contacts
23 sites in 8 countries.
23 sites in 8 countries
France9 sites
Hôpital Louis Pradel
Bron, 69677
Hopital Arnaud de Villeneuve
Montpellier, 34295
CHRU Nancy
Nancy, 54500
Hôpital Laennec
Nantes, 44093
Hôpital Pitié Salpêtrière
Paris, 75013
Georges Pompidou European Hospital
Paris, 75015
hôpital Charles Nicolle
Rouen, 76031
Hôpitaux universitaires de Strasbourg
Strasbourg, 67000
Clinique Pasteur
Toulouse, 31000
Germany3 sites
Charity Universitatsmedizin Berlin
Berlin
Medizinische Hochschule Hannover
Hanover, D-30625
Klinik für Innere Medizin III
Homburg, 66421
Czechia2 sites
Hospital of Fridek-Mistek P.O.
Frýdek-Místek, 73801
General University Hospital
Prague, 12808
Hungary2 sites
Heart and Vascular Center of Semmelweis University
Budapest, 1122
Magyar Honvedseg Egeszsegugyi Kozpont
Budapest, 1134
Netherlands2 sites
University Medical Center Groningen
Groningen, 9713GZ
Maastricht University Medical Centre
Maastricht, PO 5800
Poland2 sites
NZOZ ALL-MED Centrum Medyczne
Lodz, 94048
Clinical Military Hospital
Wroclaw, 50981
United Kingdom2 sites
University of Birmingham Institute of Cardiovascular Sciences City Hospital,
Birmingham, England, B18 7QH
Ninewells Hospital
Dundee, DD1 9SY
About this study
Official title: A Randomized, Double-blind, Multi-centre Study to Assess Safety and Efficacy of Incremental Doses of QGC001 in Patients With NYHA Class II/III Chronic Heart Failure (HF) With Left Ventricular Systolic Dysfunction Versus Placebo.
Heart Failure (HF) a common clinical condition characterized by either by a heart that does not pump sufficiently or becomes stiff. A variety of mechanisms contribute to progressive cardiac remodeling and dysfunction.
A new therapeutic approaches by preventing activation of the brain neuromodulatory pathway, may lead to improve HF.
QCG001 is a prodrug of EC33, a aminopeptidase A (APA) inhibitor. QCG001 has been shown to be an antihypertensive agent in animal models.
This study investigates the safety and efficacy of QGC001 in HF patients.
Read the detailed description
Despite advances in care, prognosis remains poor once overt Heart Failure (HF) has developed. HF is a common clinical condition characterized by either by a heart that does not pump sufficiently or becomes stiff and it is associates with higher incidences of patient illness and death in both case. A variety of mechanisms contribute to progressive cardiac remodeling and dysfunction.
A new therapeutic approaches by preventing activation of the brain neuromodulatory pathway, may lead to improve HF.
QCG001 is a prodrug of EC33, a specific and selective of the aminopeptidase A (APA) inhibitor. QCG001 has been shown to be an antihypertensive agent in animal models.
This study investigates the safety and efficacy of QGC001 up-titrated form 50mg twice daily to a maximum of 500 mg twice daily, on patients with worsening chronic HF during 28 days and 7 days after discontinuation (day 35).
6 European countries are involved in this study (France, Netherlands, Germany, Norway, Poland and United Kingdom) including 20 investigational hospitals. Patients would be followed during 35 days and inclusion period lasts until December 2017.
- Conditions
- Heart Failure
- Being tested
- QGC001, Placebo
- Keywords
- Aminopeptidase A inhibitor, Heart Failure, Up-titration, Dose-Response Relationship, Drug, Pharmacokinetics, Patient Safety, Treatment Efficacy
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QGC001Drug
PlaceboDrug
Lactose capsule manufactured to mimic QGC001 50 mg and 250 mg
| Study group | Role | What they receive |
|---|---|---|
| QGC001 | Experimental | QGC001 from 50mg to 500mg capsule twice daily, for 28 days, oral use Receives: Drug: QGC001 |
| Placebo | Placebo comparator | Placebo, capsule twice daily, for 28 days, oral use Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative decrease in NT-proBNP
Percentage of subjects with a relative decrease in NT-proBNP of more than 30% from Baseline to day 28.
Measured: 28 days
Blood pressure change
Blood pressure changes at each visit (D7, D14, D21, D28), compared to the Baseline measure
Measured: 28 days
Secondary outcomes (6)
Blood biochemistry
blood biochemistry at D7, D14, D21, D28 and D35.
Measured: 35 days
Urinary biochemistry
electrolytes, urinary osmolarity at D7, D14, D21, D28 and D35.
Measured: 35 days
Change of NT-proBNP
Changes in central lab values of NT-proBNP at D7, D14, D21, D28 and D35.
Measured: 35 days
Change of BNP
Changes in central lab values of BNP at D7, D14, D21, D28 and D35.
Measured: 35 days
Change of selected biomarker levels
Changes in central lab values from baseline in selected biomarker levels (biomarkers involved in the pathophysiology of the disease, which will be decided later) at Day 7, Day 14, Day 21, Day 28
Measured: 28 days
Quality of life Minnesota Living with Heart Failure Score
Quality of life Minnesota Living with Heart Failure Score and D0 and Day 28
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2016 (estimated)
- Study startJun 2016
- Primary completion12 Sep 2018
- Study completion12 Sep 2018
Why it stopped: insufficient recruitment
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Quantum Genomics SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Faiez Zannad, MD, Principal investigator, Centre d'investigation clinique CHU-Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02780180
- Sponsor's protocol ID
- QUID-HF_v5.0_20171120
- Acronym
- QUID-HF
- Status last verified
- Oct 2018
- First submitted
- 17 May 2016
- Last updated
- 16 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: Individual participant date would be available only by the center via eCRF
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Multi-centre Study to Assess Safety and Efficacy of Incremental Doses of QGC001 in Patients With NYHA Class II/III Chronic Heart Failure (HF) With Left Ventricular Systolic Dysfunction Versus Placebo.
- ClinicalTrials.gov ID
- NCT02780180
- Acronym / sponsor ID
- QUID-HF / QUID-HF_v5.0_20171120
- Conditions
- Heart Failure
- Keywords
- Aminopeptidase A inhibitor, Heart Failure, Up-titration, Dose-Response Relationship, Drug, Pharmacokinetics, Patient Safety, Treatment Efficacy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: insufficient recruitment
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Quantum Genomics SAIndustry (pharma, biotech, devices)
- Study start
- Jun 2016
- Primary completion
- 12 Sep 2018 (actual)
- Study completion
- 12 Sep 2018 (actual)
- First posted
- 23 May 2016 (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.
Heart Failure (HF) a common clinical condition characterized by either by a heart that does not pump sufficiently or becomes stiff. A variety of mechanisms contribute to progressive cardiac remodeling and dysfunction.
A new therapeutic approaches by preventing activation of the brain neuromodulatory pathway, may lead to improve HF.
QCG001 is a prodrug of EC33, a aminopeptidase A (APA) inhibitor. QCG001 has been shown to be an antihypertensive agent in animal models.
This study investigates the safety and efficacy of QGC001 in HF patients.
Detailed description
Despite advances in care, prognosis remains poor once overt Heart Failure (HF) has developed. HF is a common clinical condition characterized by either by a heart that does not pump sufficiently or becomes stiff and it is associates with higher incidences of patient illness and death in both case. A variety of mechanisms contribute to progressive cardiac remodeling and dysfunction.
A new therapeutic approaches by preventing activation of the brain neuromodulatory pathway, may lead to improve HF.
QCG001 is a prodrug of EC33, a specific and selective of the aminopeptidase A (APA) inhibitor. QCG001 has been shown to be an antihypertensive agent in animal models.
This study investigates the safety and efficacy of QGC001 up-titrated form 50mg twice daily to a maximum of 500 mg twice daily, on patients with worsening chronic HF during 28 days and 7 days after discontinuation (day 35).
6 European countries are involved in this study (France, Netherlands, Germany, Norway, Poland and United Kingdom) including 20 investigational hospitals. Patients would be followed during 35 days and inclusion period lasts until December 2017.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| QGC001 | Experimental | Drug: QGC001QGC001 from 50mg to 500mg capsule twice daily, for 28 days, oral use |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo, capsule twice daily, for 28 days, oral use |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- A signed and dated informed consent form prior to any study procedure
- Adult male subjects and female subjects without childbearing potential.
- Clinical diagnosis of CHF with history of NYHA class II-III for at least 3 months before randomisation.
- Documented left ventricular ejection fraction (LVEF) < 40% measured by any modality within the previous 12 months in the subject's medical history.
- Subjects must also have at least one local measurement of BNP level ≥ 300 pg/mL or NT-proBNP level ≥ 1200 pg/mL (preferred assay, local laboratory) at the screening visit (maximum 7 days before randomisation).
Key exclusion criteria (28 listed)
- BMI > 45 kg.m-2.
- Patients who require the use of HF IV therapy or oral furosemide > 250 mg (or equivalent) at any time during the 48 hours immediately before randomisation.
- Patients with unstable angina, myocardial infarction, PTCA, coronary artery bypass graft, cerebral vascular accident, or transient ischemic attack within previous 3 months (90 days) before enrolment.
- Patients whose primary cause of heart failure is mitral or aortic valve disease or congenital heart disease or hypertrophic obstructive cardiomyopathy or infiltrative cardiomyopathy (e.g. amyloidosis, sarcoidosis) or myocarditis.
- Patients with "new" permanent atrial fibrillation (AF), discovered within 3 months prior to randomization.
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 |
|---|---|---|
| QGC001 | Drug | QGC001 |
| PlaceboLactose capsule manufactured to mimic QGC001 50 mg and 250 mg | Drug | Placebo |
Primary outcome
Relative decrease in NT-proBNP
Time frame: 28 days
Percentage of subjects with a relative decrease in NT-proBNP of more than 30% from Baseline to day 28.
Blood pressure change
Time frame: 28 days
Blood pressure changes at each visit (D7, D14, D21, D28), compared to the Baseline measure
6 secondary outcomes
Blood biochemistry
Time frame: 35 days
Urinary biochemistry
Time frame: 35 days
Change of NT-proBNP
Time frame: 35 days
Change of BNP
Time frame: 35 days
Change of selected biomarker levels
Time frame: 28 days
Quality of life Minnesota Living with Heart Failure Score
Time frame: 28 days
Results and safety
The study was stopped early (reason given: insufficient recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2018.
- Individual participant dataSharing planned: No. Individual participant date would be available only by the center via eCRF
Related trials for Heart Failure
RecruitingPhase 2/3
Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-036)
Heart Failure, Left Ventricular Systolic Dysfunction
RecruitingPhase 1/2
HS235 Study in Overweight and Obese Participants With Combined Pre and Post-Capillary Pulmonary Hypertension Due to Heart Failure With Preserved Ejection Fraction
Pulmonary Hypertension, Heart Failure With Preserved Ejection Fraction
Active, not recruiting
Heart Failure Patient Management and Interventions Using Continuous Patient Monitoring Outside Hospitals and Real-world Data
Chronic Heart Failure, Heart Transplant Recipient
Enrolling by invitationObservational study
Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
Heart Failure
Not yet recruitingObservational study
Real-world Effectiveness and Safety of Savagen (Sacubitril/Valsartan) in Malaysian HFrEF Patients
Heart Failure With Reduced Ejection Fraction (HFrEF), Heart Failure
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.
Faiez Zannad, MD principal investigator
Centre d'investigation clinique CHU-Nancy
23 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing QGC001 in people with Heart Failure, run by Quantum Genomics SA at 23 sites in 8 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 28 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: stopped early, as of the sponsor's last update on 16 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in France, Germany, Czechia, Hungary, Netherlands and 3 more countries. 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: insufficient recruitment). Results are not available in the source record.
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?
Relative decrease in NT-proBNP (time frame: 28 days). The study lists 2 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 16 Oct 2018.