A clinical trial to study the effect of two drugs, inhaled milrinone and inhaled levosimendan in children with pulmonary hypertension.

The effect of inhaled milrinone and inhaled levosimendan in pulmonary hypertension in children with congenital heart disease- A randomized double blinded trial. - Nil

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/12/078330

Enrollment

Registered

2024-12-19

Start date

Unknown

Completion date

Unknown

Last updated

2025-02-03

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

Conditions

Health Condition 1: I272- Other secondary pulmonary hypertension

Interventions

Intervention1: Inhaled Levosimendan: Children with congenital heart disease with pulmonary hypertension defined as mean pulmonary artery pressure more than or equal to 25mmHg undergoing right heart ca

Eligibility

Inclusion criteria

Inclusion criteria: Children with cyanotic or acyanotic heart disease with pulmonary hypertension defined by mean pulmonary artery pressures more than or equal to 25mmHg will be enrolled in the study

Exclusion criteria

Exclusion criteria: Patients who did not show response to 100% oxygen during the right heart catheter study. Patients not willing for the study

Design outcomes

Primary

Measure	Time frame
To compare acute effects of inhaled milrinone and inhaled levosimendan on pulmonary and systemic vascular resistance and on pulmonary blood flows, systemic blood flow and pulmonary to systemic blood flow ratio.Timepoint: After completion of nebulization of each drug that is after 15minutes	—

Secondary

Measure	Time frame
To compare the acute effects of inhaled milrinone and inhaled levosimendan on oxygenation saturain aorta , pulmonary artery and mixed venous saturation and 2D echocardiography parameters RVOT doppler profile pulmonary artery acceleration time and volume time integralTimepoint: After the completion of inhalation of the drugs over 15 to 20 minutes	—

Countries

India

Contacts

Public ContactRajeswari N

Apollo hospitals enterprises limited

rajiarali@gmail.com8905346895

Outcome results

None listed

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