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Investigating the effect of empagliflozin in heart failure in HIV patients

The investigation of the efficacy and safety of Empagliflozin in the treatment of heart failure in people who living with HIV/AIDS: Randomized, Clinical Trial study

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20130719014054N2
Enrollment
128
Registered
2024-06-25
Start date
2024-06-21
Completion date
Unknown
Last updated
2024-07-22

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

Conditions

Heart failure with low output in HIV positive patient. Heart failure, unspecified

Interventions

Intervention 1: Intervention group: In HIV-positive patients with heart failure, empagliflozin 10 mg, made in Iran, is added to other treatments including diuretics, beta-blockers, angiotensin inhibit
Mineralocorticoid antagonists and angiotensin enzyme inhibitors made in Iran are placed and followed up for one year.

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Age >18YEARS HIV EF<50%

Exclusion criteria

Exclusion criteria: MALIGNANCY OR Opportunistic infection PREGNANCY CKD AND GFR<20

Design outcomes

Primary

MeasureTime frame
Change in the 6min walking test. Timepoint: The beginning of the study and six months later and the end of the study. Method of measurement: The patients walks in a 30-meter hall with maximum power and the time of the patient's shortness of breath is recorded, and the maximum walking time of the patient will be 6 minutes.

Secondary

MeasureTime frame
Improve cardiac output. Timepoint: Every 6 months. Method of measurement: Echocardiography.;Function class. Timepoint: Every 3months. Method of measurement: Examining the patient and asking about the degree of shortness of breath.;Lower limb edema. Timepoint: Every 3months. Method of measurement: Examination by a doctor.;Hospitalized cases. Timepoint: Every 3months. Method of measurement: Question from the patient.;Change PRO-BNP. Timepoint: EVERY 6 MONTHS. Method of measurement: LAB TEST.;Change in uric acid. Timepoint: Every 6months. Method of measurement: lab test.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMarjan Hemmatian

Tehran University of Medical Sciences

hemmatianmarjan@gmail.com+98 21 6119 0000

Outcome results

None listed

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