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A study to evaluate the effect of a drug(Sildenafil) which reduces pressures on the right side of the heart in patients with Special type of heart disease in children(FONTAN circulation).

Effect of prophylactic phosphodiesterase-5 inhibitors on perioperative and early postoperative outcomes of Fontan circulation a randomized control study - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/08/092953
Enrollment
36
Registered
2025-08-12
Start date
Unknown
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

Health Condition 1: I52- Other heart disorders in diseasesclassified elsewhere

Interventions

Intervention1: ORAL SILDENAFIL: ORAL SILDENAIL WILL BE USED IN PATIENTS WITH NORMAL GLENN PRESSURES, WITH A DOSE OF 1MG/KG TDS with maximum dose of 20 mg TDS, the drug will be give till patients under

Sponsors

SREE CHITRA TIRUNAL INSTITUTE FOR MEDICAL SCIENCES AND TECHNOLOGY,
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients with Univentricular circulation post bidirectional Glenn shunt awaiting Fontan completion with normal Glenn pressure ( <15mmHg) on cardiac catheterization.

Exclusion criteria

Exclusion criteria: 1.Contraindication to sildenafil therapy. 2.Patients who are already on any other pulmonary vasodilators. 3.Candidates for Biventricular repair. 4. Glenn pressure more than 15 mm Hg.

Design outcomes

Primary

MeasureTime frame
To assess Intraoperative Glenn pressure Pre and Post Fontan completion.Timepoint: Outcomes will be assessed when subjects undergo surgery( Fontan completion), 4 months—

Secondary

MeasureTime frame
To assess the duration of ICU, stay after FontanTimepoint: IN DAYS;To assess duration of hospital stay after Fontan completionTimepoint: IN DAYS;To assess the duration of pleural and mediastinal drains after Fontan completionTimepoint: DAYS;To calculate vasoactive inotrope score after Fontan. Timepoint: NIL;To compare change in NT pro BNP at from baseline to 1- month post Fontan completion. Timepoint: 1 MONTH—

Countries

India

Contacts

Public ContactDR RAMYA G S

SREE CHITRA TIRUNAL INSTITUTE FOR MEDICAL SCIENCES AND TECHNOLOGY

kmkmsai@gmail.com

Outcome results

None listed

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