Recruiting PHASE3 Chronic Thromboembolic Pulmonary Hypertension

New treatment option for Chronic Thromboembolic Pulmonary Hypertension

Official title Riociguat-Discontinue Effects on Right HEART in CTEPH (RED-HEART)

ClinicalTrials.gov ID: NCT06922240

What this study is testing

What is Riociguat?

Riociguat is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for chronic thromboembolic pulmonary hypertension.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
Riociguat and balloon pulmonary angioplasty (BPA) are established standard-of-care interventions for inoperable chronic thromboembolic pulmonary hypertension (CTEPH) with comparable evidence levels. However, the optimal combined treatment strategy remains unclear.
  • Phase 3: a large, late-stage study

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older

You may be able to join if

  • Age ≥18 years old
  • CTEPH was diagnosed and one of the following three factors was met: Pulmonary endarterectomy was technically impossible; Pulmonary endarterectomy is...
  • people had been treated with BPA and had received a stable dose of riociguat for ≥12 weeks
  • mPAP \< 30mmHg
  • Male people and female people of reproductive age are required to use effective contraception for at least 28 days after signing the informed consent...

You likely can't join if

  • Severe hepatic and renal insufficiency (Child-Pugh Grade C/creatinine clearance \< 30ml/min 1.73m²)
  • The presence of severe infectious disease or severe bleeding tendency
  • Combined with pulmonary hypertension of other types than CTEPH
  • Other pulmonary hypertension targeting drugs are being used
  • The expected survival time with cancer or other diseases is less than 6 months
  • Pregnancy, lactation
See the full eligibility criteria
Who can join
  • Age ≥18 years old
  • CTEPH was diagnosed and one of the following three factors was met: Pulmonary endarterectomy was technically impossible; Pulmonary endarterectomy is technically feasible, but the risk-benefit ratio is poor...
  • people had been treated with BPA and had received a stable dose of riociguat for ≥12 weeks
  • mPAP \< 30mmHg
  • Male people and female people of reproductive age are required to use effective contraception for at least 28 days after signing the informed consent form. Male people are not allowed to donate sperm and female people...
  • people voluntarily sign written informed consent
What rules you out
  • Severe hepatic and renal insufficiency (Child-Pugh Grade C/creatinine clearance \< 30ml/min 1.73m²)
  • The presence of severe infectious disease or severe bleeding tendency
  • Combined with pulmonary hypertension of other types than CTEPH
  • Other pulmonary hypertension targeting drugs are being used
  • The expected survival time with cancer or other diseases is less than 6 months
  • Pregnancy, lactation
  • people are currently participating in an treatment clinical trial
  • In the investigator's judgment, a subject's medical abnormality, physical condition, or medical history may affect his or her ability to participate in or complete the study

The study team makes the final eligibility decision.

Where it's taking place

  • Beijing, China, China

Compensation & support

A stipend or compensation may be offered.

Compensation mentioned.

ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.

Questions & answers

Do participants get paid in this trial?

This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Beijing, China, China. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.