A Phase II randomized, placebo controlled, 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 with left ventricular systolic dysfunctionShort title: QUantum genomics Incremental Dosing in Heart FailureAcronym QUID-HF” - QUID-HF

QUANTUM GENOMICS0 sites75 target enrollmentNovember 2, 2016

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Patient with worsening chronic heart failure with left ventricular systolic dysfunction
Sponsor: QUANTUM GENOMICS
Enrollment: 75
Status: Active, not recruiting
Last Updated: 4 years ago

No summary available.

Registry

who.int

Start Date

November 2, 2016

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•\*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.
•\*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).

•\*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.
•\*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.