Evaluation of Sildenafil and placebo effects on improvement of clinical and paraclinical measures on patients with severe heart failure

Double Blind Randomized Clinical Trial for Evaluation of Sildenafil and placebo effects on improvement of clinical and paraclinical measures on patients with severe Systolic Heart Failure

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT201101045544N1

Enrollment

200

Registered

2011-06-06

Start date

2011-01-21

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Condition 1: Ischemic cardiomyopathy. Condition 2: Dilated cardiomyopathy. Ischaemic cardiomyopathy Congestive cardiomyopathy

Interventions

Intervention 1: According to the study design (Randomized and double blinded)

eligible patients are given by chance drug or placebo with dose of 25mg at bedtime for 1 week and up titrated to 25mg twice daily for the next week . After 2week visit according to the patient`s condi

Treatment - Drugs

Placebo

According to the study design (Randomized and double blinded)

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactHossein Navid M.D

Shahid Rjaee Heart Center

dr_hona@yahoo.com+98 21 23921

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026