Balloon Pulmonary Angioplasty for Chronic Thromboembolic Pulmonary Hypertension

Overseen By Lyda Lesenko, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Jewish General Hospital

Must not be taking: Ace inhibitors, Arbs

Disqualifiers: Patent foramen ovale

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

40 Participants Needed

Trial Summary

What is the purpose of this trial?

Chronic thromboembolic pulmonary hypertension \[CTEPH\] is caused by pulmonary emboli that have enlarged in pulmonary arteries and have become organized into the vessel wall. Many patients with CTEPH are treated with balloon pulmonary angioplasty \[BPA\] which mechanically opens the narrow pulmonary arteries. It is unclear how much downstream functional pulmonary capillary surface area \[FCSA\] is recovered during BPA. We plan to measure FCSAIn CTEPH patients, before and after a session of BPA.

Do I need to stop my current medications for this trial?

You must stop taking angiotensin-converting enzyme inhibitors or angiotensin receptor blockers to participate in this trial.

What data supports the idea that Balloon Pulmonary Angioplasty for Chronic Thromboembolic Pulmonary Hypertension is an effective treatment?

The available research shows that Balloon Pulmonary Angioplasty (BPA) is an effective treatment for patients with chronic thromboembolic pulmonary hypertension who cannot undergo surgery. Studies from different countries, including the Netherlands, have reported positive results regarding the safety and effectiveness of BPA. The treatment has been refined over time to improve its success and reduce complications. Additionally, a multicenter registry study has confirmed its effectiveness, making it a viable alternative for those who are not candidates for the standard surgical treatment. ^{1 2 3 4 5}

What safety data exists for Balloon Pulmonary Angioplasty in treating CTEPH?

Balloon Pulmonary Angioplasty (BPA) is an emerging treatment for chronic thromboembolic pulmonary hypertension (CTEPH), especially for inoperable cases. Safety data from various studies indicate that BPA can lead to significant clinical and hemodynamic improvements. However, it is associated with a notable complication rate, including pulmonary vascular injury and bleeding. In a German study, procedure-related adverse events occurred in 9.4% of interventions, with a mortality rate of 1.8% due to pulmonary bleeding. While BPA shows promise, its safety profile requires further evaluation through randomized controlled trials to better assess the risk-benefit ratio compared to other therapies. ^{2 6 7 8 9}

Is Balloon Pulmonary Angioplasty a promising treatment for chronic thromboembolic pulmonary hypertension?

Yes, Balloon Pulmonary Angioplasty is a promising treatment for chronic thromboembolic pulmonary hypertension, especially for patients who cannot undergo surgery. It has shown potential in improving heart function and reducing symptoms. ^{4 10 11 12 13}

Eligibility Criteria

This trial is for patients with chronic thromboembolic pulmonary hypertension who are candidates for a procedure called balloon pulmonary angioplasty. People taking certain blood pressure medications or those with a heart condition known as patent foramen ovale cannot participate.

Inclusion Criteria

I am eligible for a procedure to open lung blood vessels due to chronic blood clots.

Exclusion Criteria

I am taking medication for high blood pressure.

I have a hole in my heart that didn't close after birth.

Treatment Details

Interventions

• Balloon Pulmonary Angioplasty
• Measurement of pulmonary functional capillary surface area

Trial Overview The study aims to measure the recovery of functional capillary surface area in the lungs of patients undergoing balloon pulmonary angioplasty, which is a treatment to widen narrowed arteries caused by chronic blood clots.

Participant Groups

Group I: Pre and post BPA Experimental Treatment 1 Intervention

Balloon Pulmonary Angioplasty is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as BPA for:

• Chronic Thromboembolic Pulmonary Hypertension (CTEPH)

Approved in European Union as BPA for:

• Chronic Thromboembolic Pulmonary Hypertension (CTEPH)

Approved in Canada as BPA for:

• Chronic Thromboembolic Pulmonary Hypertension (CTEPH)

Approved in Japan as BPA for:

• Chronic Thromboembolic Pulmonary Hypertension (CTEPH)

Who Is Running the Clinical Trial?

Jewish General Hospital

Lead Sponsor

Trials

144

Recruited

283,000+

Findings from Research

Balloon pulmonary angioplasty (BPA) significantly improved patient outcomes in 38 individuals with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) after six months, including better functional class and increased walking distance.

The procedure was found to be safe, with only 12% of the 172 BPA procedures resulting in non-severe complications, indicating that BPA can be a viable treatment option for patients who cannot undergo surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of balloon pulmonary angioplasty in chronic thromboembolic pulmonary hypertension in the Netherlands. van Thor, MCJ., Lely, RJ., Braams, NJ., et al.[2020]

Balloon pulmonary angioplasty (BPA) significantly improved hemodynamic parameters in patients with chronic thromboembolic pulmonary hypertension, with mean pulmonary arterial pressure decreasing from 43.2 mm Hg to 24.3 mm Hg after the procedure.

Despite a high complication rate of 36.3%, BPA demonstrated a 1-year survival rate of 96.8%, suggesting it is a viable alternative therapy for patients who cannot undergo pulmonary endarterectomy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Balloon Pulmonary Angioplasty for Chronic Thromboembolic Pulmonary Hypertension: Results of a Multicenter Registry. Ogawa, A., Satoh, T., Fukuda, T., et al.[2022]

Balloon pulmonary angioplasty (BPA) significantly improved hemodynamic parameters in patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH), with reductions in systolic pulmonary artery pressure by 27.3% and mean pulmonary artery pressure by 26% after treatment.

BPA also led to substantial clinical improvements, including a 39% increase in the 6-minute walk distance and a 62% decrease in BNP levels, with 60% of patients improving to functional class I and 40% to class II, demonstrating its efficacy and safety as a treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Balloon pulmonary angioplasty for patients with inoperable chronic thromboembolic pulmonary hypertension. Danilov, NM., Matchin, YG., Chernyavsky, AM., et al.[2019]

The refined balloon pulmonary angioplasty (BPA) procedure significantly improved the clinical status and hemodynamics of 68 patients with inoperable chronic thromboembolic pulmonary hypertension, reducing mean pulmonary arterial pressure from 45.4 mm Hg to 24.0 mm Hg (P<0.01).

Despite some patients experiencing reperfusion pulmonary injury (60%), the overall mortality rate was low, with only two deaths reported during a follow-up period of 2.2 years, suggesting that the refined BPA procedure is a safe and effective treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Refined balloon pulmonary angioplasty for inoperable patients with chronic thromboembolic pulmonary hypertension. Mizoguchi, H., Ogawa, A., Munemasa, M., et al.[2022]

Elderly patients (average age 77.2 years) with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) who are candidates for balloon pulmonary angioplasty (BPA) have a significantly higher risk of severe obstructive coronary artery disease (CAD), with 54.5% diagnosed compared to only 16.7% in matched acute pulmonary embolism survivors.

Due to this increased risk, it is recommended that all elderly CTEPH patients referred for BPA undergo routine invasive coronary angiography to assess their coronary health before proceeding with the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High prevalence of severe coronary artery disease in elderly patients with non-operable chronic thromboembolic pulmonary hypertension referred for balloon pulmonary angioplasty. Roik, M., Wretowski, D., Kostrubiec, M., et al.[2020]

Balloon pulmonary angioplasty (BPA) significantly improved hemodynamics in patients with chronic thromboembolic pulmonary hypertension (CTEPH), with mean pulmonary arterial pressure decreasing from 40 mm Hg to 29 mm Hg and pulmonary vascular resistance dropping from 5.5 Wood units to 3.3 Wood units, indicating enhanced blood flow and reduced strain on the heart.

The procedure also led to improved functional outcomes, with 61.3% of patients experiencing better New York Heart Association functional class and a notable increase in the 6-minute walk test distance from 402 m to 439 m, demonstrating enhanced exercise capacity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Balloon Pulmonary Angioplasty for Chronic Thromboembolic Pulmonary Hypertension: Initial Single-Center Experience. Anand, V., Frantz, RP., DuBrock, H., et al.[2022]

In a study of 140 patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) who underwent balloon pulmonary angioplasty (BPA), complications were common but did not lead to worse outcomes, indicating that BPA can be a safe option in expert centers.

The complication rate during BPA decreased from 21% to 14% over five years, suggesting improvements in technique or patient management, while a high baseline pulmonary vascular resistance was linked to a higher complication rate.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications of balloon pulmonary angioplasty for inoperable chronic thromboembolic pulmonary hypertension: Impact on the outcome. Wiedenroth, CB., Deissner, H., Adameit, MSD., et al.[2022]

Balloon pulmonary angioplasty (BPA) significantly improved patients' functional status and hemodynamics in a study of 56 patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH), showing a decrease in mean pulmonary artery pressure by 18% and an increase in 6-minute walk distance by an average of 33 meters.

Despite these benefits, BPA was associated with a notable risk of complications, including a 1.8% mortality rate due to pulmonary bleeding, highlighting the need for further randomized controlled trials to evaluate the long-term safety and survival benefits of this treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Balloon pulmonary angioplasty for inoperable patients with chronic thromboembolic pulmonary hypertension: the initial German experience. Olsson, KM., Wiedenroth, CB., Kamp, JC., et al.[2022]

Balloon pulmonary angioplasty (BPA) has become a recognized treatment option for patients with inoperable or residual chronic thromboembolic pulmonary hypertension, indicating its growing acceptance in clinical practice since its introduction in 2001.

The review highlights the evolving safety and efficacy profile of BPA, supported by evidence from various pulmonary hypertension centers worldwide, suggesting that BPA plays a significant role in managing chronic thromboembolic pulmonary disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evolving Role and Clinical Evidence in the Global Practice of Balloon Pulmonary Angioplasty. Jain, N., Perkins, S., Maligireddy, AR., et al.[2023]

Balloon pulmonary angioplasty (BPA) shows promising results for patients with chronic thromboembolic pulmonary hypertension (CTEPH) who are not suitable for the gold-standard treatment, pulmonary endarterectomy (PEA), and may lead to better symptomatic and hemodynamic improvements compared to medical therapy alone.

Recent data from a CTEPH European registry indicate that survival rates for CTEPH patients have significantly improved, suggesting that BPA could play a crucial role in enhancing outcomes for those with limited treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Update on balloon pulmonary angioplasty for treatment of chronic thromboembolic pulmonary hypertension. Lang, IM.[2022]

Balloon pulmonary angioplasty (BPA) significantly reduced mean pulmonary arterial pressure and pulmonary vascular resistance in patients with chronic thromboembolic pulmonary hypertension (CTEPH), with improvements observed in the six-minute walking test after a median follow-up of 5.9 months.

The procedure had a low complication rate of 6.4% and a high overall survival rate of 92.4% over three years, indicating that BPA is a safe and effective treatment option for CTEPH patients in Poland.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Balloon pulmonary angioplasty in chronic thromboembolic pulmonary hypertension: a multicentre registry. Darocha, S., Roik, M., Kopeć, G., et al.[2023]

Balloon pulmonary angioplasty (BPA) using intravascular imaging was performed on eight patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH), achieving a success rate of 88% and significant improvements in pulmonary artery pressure and vascular resistance.

After four weeks, patients showed notable clinical improvements, including enhanced functional capacity and increased walking distance, indicating that BPA is a safe and effective treatment option for CTEPH.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Balloon pulmonary angioplasty for the treatment of chronic thromboembolic pulmonary hypertension]. Sepúlveda, P., Ortega, J., Armijo, G., et al.[2019]

Balloon pulmonary angioplasty (BPA) significantly reduced mean pulmonary arterial pressure (mPAP) from 38±11 mm Hg to 20±4 mm Hg in 60 patients with chronic thromboembolic pulmonary hypertension (CTEPH), indicating its efficacy as a treatment option.

Improvements in ECG findings related to right ventricular hypertrophy (RVH) were observed after BPA, with specific ECG changes correlating with better functional status at 6 months follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improvement in the electrocardiograms associated with right ventricular hypertrophy after balloon pulmonary angioplasty in chronic thromboembolic pulmonary hypertension. Nishiyama, T., Takatsuki, S., Kawakami, T., et al.[2022]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Safety and efficacy of balloon pulmonary angioplasty in chronic thromboembolic pulmonary hypertension in the Netherlands. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Balloon Pulmonary Angioplasty for Chronic Thromboembolic Pulmonary Hypertension: Results of a Multicenter Registry. [2022]

3. Russia (Federation) pubmed.ncbi.nlm.nih.gov

Balloon pulmonary angioplasty for patients with inoperable chronic thromboembolic pulmonary hypertension. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Refined balloon pulmonary angioplasty for inoperable patients with chronic thromboembolic pulmonary hypertension. [2022]

5. Poland pubmed.ncbi.nlm.nih.gov

High prevalence of severe coronary artery disease in elderly patients with non-operable chronic thromboembolic pulmonary hypertension referred for balloon pulmonary angioplasty. [2020]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Balloon Pulmonary Angioplasty for Chronic Thromboembolic Pulmonary Hypertension: Initial Single-Center Experience. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Complications of balloon pulmonary angioplasty for inoperable chronic thromboembolic pulmonary hypertension: Impact on the outcome. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Balloon pulmonary angioplasty for inoperable patients with chronic thromboembolic pulmonary hypertension: the initial German experience. [2022]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Evolving Role and Clinical Evidence in the Global Practice of Balloon Pulmonary Angioplasty. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Update on balloon pulmonary angioplasty for treatment of chronic thromboembolic pulmonary hypertension. [2022]

11. France pubmed.ncbi.nlm.nih.gov

Balloon pulmonary angioplasty in chronic thromboembolic pulmonary hypertension: a multicentre registry. [2023]

12. Chile pubmed.ncbi.nlm.nih.gov

[Balloon pulmonary angioplasty for the treatment of chronic thromboembolic pulmonary hypertension]. [2019]

13. Ireland pubmed.ncbi.nlm.nih.gov

Improvement in the electrocardiograms associated with right ventricular hypertrophy after balloon pulmonary angioplasty in chronic thromboembolic pulmonary hypertension. [2022]