Early intervention for mild or borderline pulmonary arterial hypertension (PAH) associated with connective tissue diseases

Early intervention for mild or borderline pulmonary arterial hypertension (PAH) associated with connective tissue diseases - Keio university clinical trial for early pulmonary arterial hypertension with connective tissue diseases (KEEP-ACTIVE study)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000001350

Enrollment

Registered

2008-10-01

Start date

2008-09-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Pulmonary arterial hypertension (PAH) associated with connective tissue disease

Interventions

Beraprost sodium Beraprost sodium and Sildenafil citrate

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Patients who are followed up at institutions in which this clinical trial is exected. 2)Patients who fulfill the classification criteria of collagen diseases such as SLE, SSc, PM/DM, and MCTD. 3)Mean pulmonary arterial pressure is over 20 mmHg and PCWP is less than 15 measured by right heart catheterization. 4) Patients classified as WHO functional class I or II

Exclusion criteria

Exclusion criteria: 1) Hypersensitivity to Sildenafil or Beraprost. 2) Patients with chronic pulmonary thromboembolism. 3) Patients who will be on home oxygen therapy 4) Patients who will be classified as WHO class III or IV 5) Patients with severe ischemic heart diseases or cardiomyopathy 6) Patients with malignancy

Design outcomes

Primary

Measure	Time frame
Time to clinical worsening	—

Countries

Japan

Contacts

Public ContactHidekata Yasuoka

Department of Internal Medicine, Keio University School of Medicine Division of Rheumatology

yasuokah@z8.keio.jp03-3353-1211

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026