Safety and Efficacy study of CRD-102 in patients with Heart Failure with Preserved Ejection Fractio
- Conditions
- Heart Failure with Preserved Ejection FractionCardiovascular - Other cardiovascular diseases
- Registration Number
- ACTRN12616000619448
- Lead Sponsor
- Cardiora pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 24
1.Subject is willing and able to provide informed consent
2.Subject is willing and able to comply to all protocol requirements and procedures, including visits
3.Males and Females 18 years of age or older
4.Patients with symptoms of heart failure (NYHA III)
5.LVEF>40% at screening
6.HF Hospitalisation within 12 months or NT-BNP>400pg/mL (in SR) or NT-BNP>600pg/mL (in AF)
7.Septal E/e’>12 and <20
8.Left atrial volume index >28ml/m2
9.Stable medical therapy including diuretics for 2 weeks
If subject is female of childbearing potential, the subject agrees to use an accepted form of contraception throughout the study, including follow-up. (Women who are post-menopausal for at least 2 years or are surgically sterile are not considered to be of childbearing potential.)
1.Subject has had a myocardial infarct (MI) within 90 days before Screening
2.Subject is listed for heart transplant or a LVAD
3.Subject has a systolic blood pressure less than 90 mm Hg at time of screening
4.Subject has undergone cardiac surgery within the 60 days before screening
5.Subject is suspected of having symptoms primarily related to pericardial disease as suggested by relevant imaging or hemodynamic features
6.Subject has a moderate or greater degree of cardiac valvular stenosis or regurgitation
7.Subject has, at screening, clinically significant hepatic disease (serum total bilirubin equal to 3.0 mg/dL [= 51.3 micromol/L]), renal disease (eGFR less than 30 mL/min), or hematologic, gastrointestinal, immunologic, endocrine, metabolic, or central nervous system disease
8.Subject is symptomatically too unwell to be considered for trial, as evidenced by 6MWT less than 150m
9.Symptomatic ventricular arrhythmia or ICD firing within 90 days before screening
10.Poorly controlled atrial fibrillation (resting heart rate greater than 100 bpm)
11.Subjects who are receiving flecainide, encainide, propafenone, dofetilide, or disopyramide up to 2 weeks prior to screening
12.Subjects who have received within 7 days before the Screening or dosing visits:
a.An IV positive inotropic agent
b.A human B-type natriuretic peptide, including nesiritide
c.An oral or IV phosphodiesterase III inhibitor (PDEI III), including levosimendan and cilostazol
13.Subjects who have the following laboratory results at screening
a.Serum potassium concentration less than 4.0 or greater than 5.5 mEq/L
b.Serum magnesium concentration less than 1.0 mEq/L
c.Serum digoxin concentration less than 1.2 ng/mL
14.Female subjects who are pregnant and/or lactating
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method -Change in E/e’ from baseline of patients receiving CRD-102 vs placebo, assessed by Echocardiography.[Echocardiography at Screening and Day 43];-Safety and tolerability of CRD-102, Adverse event monitoring e.g arrhythmia, assessed using 12-lead ECG, Holter monitoring or Internal Cardiac Defibrillator (ICD) checks. Renal function, assessed using serum bloods.<br>[Adverse event monitoring Days 1, 15, 29, 43, 12-lead ECG at Baseline, day 15, 29 and 43. Holter monitor (for patients without ICD) at Baseline, Day 29 and 43. ICD check at Baseline and Day 43. laboratory bloods at Screening, Day 1, 15, 29 and 43.]
- Secondary Outcome Measures
Name Time Method