Interventions Against Insulin Resistance in Pulmonary Arterial Hypertension

Overview

Información sobre este estudio

The primary purpose of this study is to determine the impact of two interventions against insulin resistance on the composite endpoint of 10% improvement in baseline six minute walk distance or improvement in WHO functional class.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

Inclusion Criteria:

  • Diagnosed with idiopathic, heritable, scleroderma, or drug- or toxin-associated pulmonary arterial hypertension (PAH) according to World Health Organization consensus recommendations.
  • Repaired simple congenital heart disease or unrepaired ASD.
  • Stable PAH-specific medication regimen for three months prior to enrollment. Subjects with only a single diuretic adjustment in the prior three months will be included. Adjustments in IV prostacyclin for side effect management are allowed.
  • Subjects must own a Bluetooth-capable modern smartphone capable of receiving and sending text messages and an active data plan.
  • FEV1 > or = 60% predicted and no more than mild abnormalities on lung imaging.
  • WHO Functional Class I-III.
  • Ambulatory.

Exclusion Criteria:

  • Prohibited from normal activity due to wheelchair bound status, bed bound status, reliance on a cane/walker, activity-limiting angina, activity-limiting osteoarthritis, or other condition that limits activity.
  • Pregnancy.
  • Diagnosis of PAH etiology other than idiopathic, heritable, or associated with drugs or toxins.
  • Drug and toxin associated PAH patients with active drug use.
  • WHO Functional class IV heart failure.
  • FEV1 > or = 65% predicted AND normal chest imaging.
  • WHO Functional class IV heart failure.
  • Requirement of > 1 diuretic adjustment in the prior 30 days.
  • Preferred form of activity is not measured by an activity tracker (swimming, ice skating, stair master, or activities on wheels such as bicycling or rollerblading).
  • Type I diabetes mellitus.
  • Prior diagnosis of cirrhosis.
  • Untreated hypo- or hyper-thyroidism.
  • eGFR by MDRD < 40mL/min.

Eligibility last updated 1/7/22. Questions regarding updates should be directed to the study team contact.

 

 

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus Contacto

Rochester, Minn.

Investigador principal de Mayo Clinic

Robert Frantz, M.D.

Abierto para la inscripción

Contact information:

Louise Durst R.N.

(507) 284-1838

durst.louise@mayo.edu

More information

Publicaciones

Publications are currently not available