Clinical trial NCT02388464 (phase 1, status: completed)
Conditions: congestive heart failure
ICD codes: I50.20, I50.21, I50.22, I50.30, I50.31, I50.32, I50.40
Drugs: mtp-131, mtp-131, mtp-131, placebo
SMILES: CC1=CC(O)=CC(C)=C1C[C@H](NC(=O)[C@H](N)CCCNC(N)=N)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CC1=CC=CC=C1)C(N)=O, CC1=CC(O)=CC(C)=C1C[C@H](NC(=O)[C@H](N)CCCNC(N)=N)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CC1=CC=CC=C1)C(N)=O, CC1=CC(O)=CC(C)=C1C[C@H](NC(=O)[C@H](N)CCCNC(N)=N)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CC1=CC=CC=C1)C(N)=O, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Inclusion Criteria:

          -  Chronic ischemic or non-ischemic cardiomyopathy of at least 6 months duration from the
             time of the initial diagnosis.

          -  LVEF ≤35% by 2-D echocardiogram.

          -  Diagnosis of NYHA Class II or III HF for a minimum of 6 months prior to the Screening
             Visit.

          -  HF is considered to be stable and no hospitalization for HF has occurred within the
             previous 3 months prior to the Screening visit.

          -  Treatment with appropriate pharmacologic therapy for HF including, but not limited to,
             angiotensin converting enzyme inhibitor (ACEI) and/or angiotensin receptor blocker
             (ARB), and an evidence-based beta blocker for the treatment of HF (i.e. carvedilol,
             bisoprolol, or extended-release metoprolol).

          -  Dose and dose regimen of pharmacologic treatments for HF must be stable for a minimum
             of 1 month prior to the Screening Visit.

          -  Females of child-bearing potential must have a negative serum pregnancy test at the
             Screening Visit and Day 1.

        Exclusion Criteria:

          -  LV end-diastolic dimension (LVEDD), by the same method as qualifying LVEF, is >80 mm
             or LVEDD indexed to body surface area is >0.45.

          -  Unstable angina pectoris within 1 month before initiation of screening procedures.
             Unstable angina is defined as the occurrence of chest pain more frequently than usual,
             pain at rest or upon minimal exertion, or protracted episodes of pain without any
             discernible trigger, and/or chest pain that persists despite use of vasodilatory
             therapy (e.g., nitroglycerin).

          -  Coronary or peripheral artery revascularization procedure within 2 months prior to the
             Screening Visit.

          -  An acute myocardial infarction within 3 months prior to the Screening Visit.

          -  Placement of an automated implantable cardioverter defibrillator (AICD) or any
             hardware associated with resynchronization therapy.

          -  Atrial fibrillation at the Screening or Baseline Visits.

          -  Uncontrolled hypertension defined as a systolic blood pressure (BP) > 180 mm Hg or a
             diastolic BP >110 mm Hg on at least 2 consecutive readings.

          -  Requirement for valve or other cardiac surgery

          -  Cardiac surgery or valvuloplasty within 2 months prior to the Screening Visit.

          -  General surgery within 1 month prior to the Screening Visit

          -  Restrictive cardiomyopathy, obstructive cardiomyopathy, pericardial disease,
             amyloidosis, infiltrative cardiomyopathy, uncorrected thyroid disease, or dyskinetic
             left ventricular aneurysm.

          -  Cerebrovascular accident or transient ischemic attack within 3 months prior to the
             Screening Visit.

          -  Estimated glomerular filtration rate (eGFR) <40 mL/min, using the Modification of Diet
             in Renal Disease (MDRD) Study equation

          -  Serologic evidence of hepatitis B or C infection.

          -  Known acquired immunodeficiency syndrome or HIV-positive status, or diagnosis of
             immunodeficiency.

               -  Other protocol-defined inclusion/exclusion criteria may apply.