Blood thinners for high blood pressure in lungs - A Pilot Randomized Control Trial

Oral Anticoagulation ( Vitamin K antagoist) for Pulmonary Artery Hypertension(PAH)- A Pilot Randomized Control Trial - NIL

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/10/059337

Enrollment

186

Registered

2023-10-31

Start date

Unknown

Completion date

Unknown

Last updated

2024-04-01

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

Conditions

Health Condition 1: I270- Primary pulmonary hypertension

Interventions

Intervention1: Oral Anticoagulation(Vitamin K antagonist) with standard treament: All patients of group 1 PAH coming to OPD,IPD and emergency will be recruited in the study.The patient population wit

Eligibility

Inclusion criteria

Inclusion criteria: 1.Age is =18 years 2. Patient consents to participation 3.Group 1 Pulmonary hypertension 4. WHO functional class II or III 5. All PAH patients documented by a diagnostic right heart catheterization (RHC) . 6. Patient must be on a stable doses of pulmonary vasodilator therapy

Exclusion criteria

Exclusion criteria: 1.Patient with a strong indication for anticoagulation i.e., Atrial fibrillation,CTEPH, thromboembolism, stroke 2.Acutely decompensated heart failure within 30 days3 months prior to randomisation 3.Left ventricular ejection fraction (LVEF) 15 mmHg on right heart catheterization during baseline evaluation 4.PAH secondary to valvular heart disease 5.Stopped receiving any pulmonary hypertension chronic general supportive therapy (e.g, diuretics, oxygen, anticoagulants, digoxin) within 60 days prior to randomisation 6. WHO class IV 7. Contraindication to anticoagulation

Design outcomes

Primary

Measure	Time frame
1.Change in PVRI from baseline and after 6-month therapy of Vitamin K antagonist Timepoint: 1st Year: Ethical clearance Patient recruitment Ordering of Medicine Sample collection Hiring of Manpower 2nd Year: Patient recruitment Cardiac catheterisation Data compilation 3rd Year: Data compilation,analysis Summary and conclusion	—

Secondary

Measure	Time frame
1.all cause death,all cause hospitalization and hospitalization due to worsening of PAH 2.To assess the Cchange in 6-minute walk tdistance est from baseline and after 6 months therapy of adjusted dose of Vitamin K antagonist 3.To assess the change in NTPro BNP from baseline and after 6 months therapy of adjusted dose of Vitamin K antagonist 4.To assess serious adverse events of anticoagulation Timepoint: 1st Year: Ethical clearance Patient recruitment Ordering of Medicine Sample collection Hiring of Manpower 2nd Year: Patient recruitment Cardiac catheterisation Data compilation 3rd Year: Data compilation,analysis Summary and conclusion	—

Measure

Time frame

1.all cause death,all cause hospitalization and hospitalization due to worsening of PAH 2.To assess the Cchange in 6-minute walk tdistance est from baseline and after 6 months therapy of adjusted dose of Vitamin K antagonist 3.To assess the change in NTPro BNP from baseline and after 6 months therapy of adjusted dose of Vitamin K antagonist 4.To assess serious adverse events of anticoagulation Timepoint: 1st Year: Ethical clearance Patient recruitment Ordering of Medicine Sample collection Hiring of Manpower 2nd Year: Patient recruitment Cardiac catheterisation Data compilation 3rd Year: Data compilation,analysis Summary and conclusion

—

Countries

India

Contacts

Public ContactSATYAVIR YADAV

AIIMS New Delhi

drsatyaviryadav87@gmail.com01126593464

Outcome results

None listed

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