Evaluation of Sildenafil and placebo effects on improvement of clinical and paraclinical measures on patients with severe heart failure
Phase 2
- Conditions
- Condition 1: Ischemic cardiomyopathy. Condition 2: Dilated cardiomyopathy.Ischaemic cardiomyopathyCongestive cardiomyopathy
- Registration Number
- IRCT201101045544N1
- Lead Sponsor
- Vice chancellor for research shahid Rajaee research center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria
Inclusion criteria :
Adult with at least class II CHF ; Able to give Informed consent
Exclusion Criteria :
Unable to give informed consent ; Currently taking nitrates ; Comorbid condition(s) that could limit walking ; resting SBP<90mmHg
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Exertional dyspnea. Timepoint: before trial and then every 2 weeks for one month and monthly thereafter. Method of measurement: NYHA functional class classification.;6-minute walk test. Timepoint: Before and after trial. Method of measurement: total distance walked.;Quality of life (QoL). Timepoint: Before and at the end. Method of measurement: MacNew HRQL Questionnaire- Farsi version.;Left ventricular ejection fraction(EF). Timepoint: before and at the end. Method of measurement: Echocardiography with Vivid3 for measuring LVEF by 2D and simpson method.
- Secondary Outcome Measures
Name Time Method Mortality. Timepoint: every 2 week twice then monthly for 3 month. Method of measurement: Mortality.;Headache. Timepoint: every 2 week twice then monthly for 3 month. Method of measurement: Questionnaire.;Hypotension. Timepoint: every 2 week twice then monthly for 3 month. Method of measurement: BP measurement with mercury sphygmomanometer.;Priapism. Timepoint: every 2 week twice then monthly for 3 month. Method of measurement: Questionnaire.