Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2025-12-24 @ 9:24 PM
NCT ID:
NCT02687932
Eligibility Criteria:
Inclusion Criteria:
1. Patients must agree to the study protocol and provide written informed consent
2. Outpatients ≥ 20 years of age, male or female
3. Patients with secondary functional MR (stage B and C) and LV dysfunction
* Symptoms due to coronary ischemia or heart failure may be present but symptoms due to MR should be absent
* Normal mitral valve leaflets and chords
* Regional or global wall motion abnormalities with mild or severe tethering of leaflet
* ERO \> 0.10 cm2
* 25% \< LV ejection fraction \< 50%
4. Dyspnea of NYHA functional class II or III
5. Patients must be on stable, optimized dose of an ACE inhibitors or ARBs for at least 4 weeks prior to study entry
Exclusion Criteria:
1. History of hypersensitivity or allergy to the study drug, drugs of similar chemical classes, ARBs, or NEP inhibitors as well as known or suspected contraindications to the study drug
2. Known history of angioedema
3. Any evidence of structural mitral valve disease, including prolapse of mitral leaflets and rupture of chords or papillary muscles
4. Current acute decompensated heart failure or dyspnea of NYHA functional class IV
5. Medical history of hospitalization within 6 weeks
6. Symptomatic hypotension and/or a SBP \< 100 mmHg at screening
7. Estimated GFR \< 30 mL/min/1.73m2
8. Serum potassium \> 5 mmol/L at screening
9. Evidence of hepatic disease as determined by any one of the following: AST or ALT values exceeding 2 x upper limit of normal (ULN) at screening visit (Visit 0), history of hepatic encephalopathy, history of esophageal varices, or history of portacaval shunt
10. Acute coronary syndrome, stroke, major CV surgery, PCI within 3 months
11. Planned coronary revascularization or mitral valve intervention within 1 year
12. Heart transplantation or implantation of cardiac resynchronization therapy
13. History of severe pulmonary disease
14. Significant aortic valve disease
15. Primary aldosteronism
16. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using a barrier method plus a hormonal method
17. Pregnant or nursing (lactating) women
18. Any clinically significant abnormality identified at the screening visit, physical examination, laboratory tests, or electrocardiogram which, in the judgment of the investigator, would preclude safe completion of the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT02687932
Study Brief:
Protocol Section:
NCT02687932