A multicenter study to evaluate safety and tolerability in patients with chronic heart failure and reduced ejection fraction from PARADIGM-HF receiving open label LCZ696
- Conditions
- 10019280Heart Failure
- Registration Number
- NL-OMON42095
- Lead Sponsor
- ovartis Pharma B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 75
1. Written informed consent for the extension must be obtained before any assessment is performed.
2. Patients who have been enrolled and treated with double-blind study medication in the PARADIGM-HF study (protocol CLCZ696B2314) and are able to be safely enrolled into the open-label trial as judged by the investigator.
1. Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer.
2. History of hypersensitivity or allergy to any of the study drugs, drugs of similar chemical classes, ACEIs, ARBs, or NEP inhibitors as well as known or suspected contraindications to LCZ696.
3. Known history of angioedema.
4. Requirement of simultaneous treatment with both ACEIs and ARBs.
5. Current acute decompensated HF (exacerbation of chronic HF manifested by signs and symptoms that may require intravenous therapy).
6. Symptomatic hypotension and/or a SBP < 100 mmHg at Visit 1 (screening).
7. Estimated GFR < 30 mL/min/1.73m2 as measured by the simplified MDRD formula at Visit 1 (screening).
8. Presence of bilateral renal artery stenosis.
9. Serum potassium > 5.2mmol/L at Visit 1 (screening).
10. Evidence of hepatic disease as determined by any one of the following: AST or ALT values exceeding 3 x ULN at Visit 1, history of hepatic encephalopathy, history of esophageal varices, or history of portacaval shunt.
11. Pregnant or nursing (lactating) women.
12. Women of childbearing potential.
13. Any condition, not identified in the protocol, that in the opinion of the investigator is likely to prevent the patient from safely tolerating LCZ696 or complying with the requirements of the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary assessments for safety is the reporting of all (S)AEs.<br /><br>The assessment of safety will be based primarily on the frequency of adverse<br /><br>events of special interest, sitting systolic and diastolic blood pressure,<br /><br>heart rate, and serious adverse events suspected by the investigators to be<br /><br>related to LCZ696.</p><br>
- Secondary Outcome Measures
Name Time Method <p>N/A</p><br>