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rolihin A in heart Failure

Phase 3
Conditions
heart failure with reduced ejection fraction.
Heart failure
Registration Number
IRCT20210216050375N1
Lead Sponsor
Mashhad University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
Male
Target Recruitment
10
Inclusion Criteria

Male
Between the ages 25 to 85 years
Left ventricular ejection fraction equal or lower than 40%
New York Heart Association functional class equal or greater than II
Received standard treatment of heart failure (including Angiotensin-converting enzyme 2 inhibitors or Angiotensin II receptor inhibitors and beta blockers) for at least 2 weeks
Signed informed consent

Exclusion Criteria

History of myocardial infarction during the 8 past weeks
History of any malignant disease
Renal failure (eGFR lower than 20 ml/1.73 m2/min)
hepatic disorder (aminotransferase > 2x upper limit of normal)
Extensive heart surgery or angioplasty during the past 30 days
Allergy and/or hypersensitivity to specific drugs or substances related to drug used in this clinical trial
uncontrolled high blood pressure (Systolic blood pressure higher than 180 mmHg and diastolic blood pressure higher than 100 mmHg)

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
eft ventricular ejection fraction. Timepoint: Before and 1 month after intervention. Method of measurement: Echocardiography.
Secondary Outcome Measures
NameTimeMethod
-terminal pro b-type natriuretic peptide (NTproBNP). Timepoint: Before and 1 month after intervention. Method of measurement: Evaluation in serum by using a commercially available kit.;NYHA functional class. Timepoint: Before and 1 month after intervention. Method of measurement: Evaluation of symptoms by clinician.;Serum cardiac troponin. Timepoint: Before and 1 month after intervention. Method of measurement: Evaluation in serum by using a commercially available kit.
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