ischaemic cardiomyopathy MedDRA version: 20.0 Level: LLT Classification code 10077980 Term: Chronic systolic heart failure System Organ Class: 100000004849
Conditions
Interventions
Trade Name: Januvia
Product Name: Junuvia
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Sitagliptin
CAS Number: 486460-32-6
Other descriptive name: Sitagliptin phosphate
Concentration u
Sponsors
Imperial College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a) Age: 25-70 years old b) Gender: male or female c) Evidence of coronary artery disease with ejection fraction of =65 years) yes F.1.3.1 Number of subjects for this age range 12
Exclusion criteria
Exclusion criteria: a)Females of childbearing potential and males must be willing to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) from the time consent is signed until 6 weeks after treatment discontinuation. Double contraception is advised. b)Females of childbearing potential must have a negative pregnancy test within 7 days prior to being registered for trial treatment. NOTE: Subjects are considered not of child bearing potential if they are surgically sterile (i.e. they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal. c) Females must not be breastfeeding. d) Have contraindications to trial treatment or incompatible concurrent treatments (as listed in SmPc). e) Recent involvement in other research. f) Allergies to excipients of IMP g) Cardiac thrombus h) Have contraindications for MRI i) Malignancy j) Severe COPD k) Unstable coronary artery disease l) Unstable cardiac arrhythmia m) Severe renal impairment n) Severe liver failure o) Severe valvular disease p) Autoimmune disease p) Alcohol abuse q) Drugs abuse r) Smoking s) Unwilling to use contraception during study period t) Life expectancy less than a year u) Active participation in other clinical trial v) Any other criteria that the investigators deem not suitable that not apparent the drafting of the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Trial 1: (1) Primary: (1) to assess the effect of shockwave energy and pulse number on the cardiac-to-peripheral blood gradients of high-throughput cytokine panel (minimum SDF1, MCP1, VEGF, substance P) and (2) patients’ safety and tolerability to treatments. Trial (2): Primary: 1) to assess whether there is a change in EF as assessed using Cardiac MRI from baseline to end of trial period compared to controls. ;Secondary Objective: Trial 1: Secondary: (1) composite cardiac events [MACEs]: death and mode of death, rehospitalisation for worsening heart failure, recurrent myocardial infarction, sustained ventricular tachycardia, revascularization, and stroke, (2) to assess whether there is any change in cardiac imaging parameters (eg. EF, global and segmental strain parameters, MRI mapping of tissue characteristics, scar, perfusion) of baseline compared to end of 16-weeks period and at end of second cycle, (3) change the CD immunophenotypes of the marrow progenitors before and after shockwave treatments, (4) to assess whether the addition of DPP-IV inhibitor to shockwave treatment will release more marrow progenitors, (5) to assess whether the addition of PTH to DPP-IV inhibitor will release more marrow progenitors than DPP-IV inhibitor to shockwave treatment alone (6) the influence of infarct transmurality (segmental phenotype on production of secretomes, (7) assess cardiopulmonary exercise parameters: VO2max and V;Primary end point(s): Primary outcomes • Trial 1: (1) The abundance of blood cytokines/proteins (minimum of SDF1, VEGF, MCP1 & substance P) in the cardiac venous blood and peripheral blood, and their difference (gradients), taken before and after shockwave treatments will be taken for analysis in a continuous form. • Trial 1: Safety and tolerability to treatments will be assessed by examining the frequency and severity of adverse events (AEs). It will be taken for analysis in a categorical form. Trial (2): The change in EF at baseline, end | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Trial (1): - Any major cardiac events (MACEs): events death and mode of death, rehospitalisation for worsening heart failure, recurrent myocardial infarction, ventricular tachycardia, revascularization, and stroke. It will be taken for analysis in categorical form. - any change in cardiac imaging parameters (eg. EF, regional strain, strain rate, global longitudinal strain, MRI mapping of tissue characteristics, scar, perfusion) of baseline compared to end of 16-week and 32-week. It will be taken for analysis in a continuous form. - Rise in other proteins (secretomes): It will be taken for analysis in a continuous form. - Rise in the CD immunophenotypes of the marrow progenitors before and after shockwave treatments. It will be taken for analysis in a continuous form. - Rise in marrow progenitors after the addition of DPP-IV inhibitor to shockwave treatment will release more. It will be taken for analysis in a continuous form. - Rise in marrow progenitors after the addition of PTH to DPPIV inhibitor than DPP-IV inhibitor to shockwave treatment alone. It will be taken for analysis in a continuous form. - the influence of infarct transmurality (segmental phenotype) on production of SDF1-a. It will be taken for analysis in a continuous form. - Assess cardiopulmonary exercise parameters: VO2max and VE/VCO2 slope. It will be taken for analysis in a continuous form. - Improvement in NT-ProBNP. It will be taken for analysis as a continuous form. Trial 2: - Safety and tolerability to treatments will be assessed by examining the frequency and severity of adverse events (AEs). It will be taken for analysis in a categorical form. - Any major cardiac events (MACEs): events death and mode of death, rehospitalization for worsening heart failure, recurrent myocardial infarction, ventricular tachycardia, revascularization, and stroke. It will be taken for analysis in categorical form. - Any change in other cardiac imaging parameters (regional strain, strain | — |
Countries
United Kingdom
Outcome results
None listed