Baltimore, MDNCT06992440Now EnrollingIRB Ready

Pulmonary Arterial Hypertension Clinical Trial in Baltimore, MD

Access cutting-edge pulmonary arterial hypertension treatment through this phase 2 clinical trial at a research site in Baltimore. Study-provided care at no cost to qualified participants.

Sponsored by Gustavo A Heresi, MD, MS

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Expert Care in Baltimore

Access pulmonary arterial hypertension specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related pulmonary arterial hypertension treatment provided free

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Check if you qualify for this pulmonary arterial hypertension clinical trial in Baltimore, MD

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Why Participate?

  • No-Cost Study Care

  • Local to Baltimore

    Convenient for MD residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Baltimore site if eligible
  4. 4Begin participation

About This Pulmonary Arterial Hypertension Study in Baltimore

Randomized, triple-masked, parallel arm clinical trial of empagliflozin versus placebo in pulmonary arterial hypertension (PAH) participants on stable approved PAH-targeted medical therapy.

Sponsor: Gustavo A Heresi, MD, MS

Who Can Participate

Inclusion Criteria

In order to be eligible to participate in this study, an individual must meet all the following criteria:
Provision of signed and dated informed consent form
Ability and stated willingness to comply with all study procedures and availability for the duration of the study
Ability to read and write in English
Male or female, aged 18 years or older, with group 1 PAH, idiopathic, heritable, associated with drugs and toxins, associated with connective tissue disease and with congenital heart disease (simple repaired or unrepaired defects) according to the current guidelines and adjudicated by the local PI
PAH confirmed by right heart catheterization in the last 5 years
RV dysfunction defined as FAC ≤ 40.0% on echocardiography performed during the screening visit. In PVDOMICS, FAC has a strong correlation with CMR RV ejection fraction; group 1 PAH patients with an FAC ≤ 40% (mean 27.0 ± 8.0%) had a mean RV ejection fraction of 35.5 ± 11.3% CMR RV ejection fraction ≤ 54% classifies PAH as intermediate (37-54%) or high (\<37%) risk under current guidelines. However, to ensure we recruit patients with significantly impaired RV function, patients with RV FAC between 35.0-40.0% on the screening echocardiogram will have to meet at least one of the following additional criteria: a) TAPSE/sPAP ratio \< 0.31 mm/mmHg; b) elevated right atrial pressure defined as inferior vena cava (IVC) \> 2.1 cm in diameter and the IVC does not collapse with sniff/respiration; c) RV enlargement defined as RV basal diameter ≥ 4.1 cm; d) RV free wall longitudinal strain ≥ -22%; e) Interventricular septal flattening; and f) RV outflow tract mid or late systolic notching.
On FDA-approved PAH-targeted therapy (any combination including infused prostacyclin analogues and sotatercept) with stable doses for at least 8 weeks or 24 weeks for sotatercept prior to the screening visit and no clinical plans to change this therapy.
Diuretic doses stable for at least 4 weeks prior to screening. After screening, diuretic doses may be changed as directed by the site PIs and/or the treating physician.
Ability to take oral medication and willingness to adhere to the study drug regimen.
For females of reproductive potential: use of highly effective contraception for at least 4 weeks prior to screening and agreement to use such a method during study participation and for an additional 2 weeks after the end of study drug administration
Able to have baseline and week 24 CMR according to Imaging Core criteria, as adjudicated by the Site PI

Exclusion Criteria

An individual who meets any of the following criteria will be excluded from participation in this study:
Current use of insulin, insulin secretagogues (sulfonylureas and meglitinides), lithium or an SGLT2 inhibitor
Use of an SGLT2 inhibitor within the past 3 months prior to screening
Prior documented inability to tolerate an SGLT2 inhibitor
Volume depletion, as ascertained by the site PI, at screening or baseline
History of diabetic ketoacidosis or type 1 diabetes mellitus
Chronic alcohol or drug abuse
More than one bacterial or yeast genitourinary tract infection in the year prior to enrollment
Estimated glomerular filtration rate under 30 mL/minute/1.73m2 or on renal replacement therapy
Pregnancy or lactation
Known allergy or hypersensitivity to empagliflozin or another SGLT-2 inhibitor
Currently taking or has taken another investigational drug within the past 4 weeks
Enrollment in another randomized intervention trial. (Participants participating in observational trials will not be excluded).
Decompensated right heart failure, as adjudicated by the site PI.
Screening HbA1c \>10% with symptoms such as polyuria and polydipsia

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Baltimore?

Yes, this clinical trial (NCT06992440) has an active research site in Baltimore, MD that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Pulmonary Arterial Hypertension Treatment Options in Baltimore, MD

If you're searching for pulmonary arterial hypertension treatment options in Baltimore, MD, this clinical trial (NCT06992440) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Baltimore research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced pulmonary arterial hypertension specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all pulmonary arterial hypertension clinical trials near you to find additional studies recruiting in your area.

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