Exercise Hemodynamic, Right Ventricular Coupling and Echocardiography in Pulmonary Hypertension

NCT04663217 | Completed

• 1 other identifier: AZ 11716
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 2

Brief Summary

This study aims to investigate the exercise profile in pulmonary hypertension patients with either pulmonary arterial hypertension, chronic thromboembolic pulmonary hypertension or pulmonary hypertension due to left heart disease and in disease control.

Conditions

Hypertension, Pulmonary; Hypertension, Pulmonary Arterial

Keywords

exercise; Hypertension, Pulmonary

Outcome Measures

Primary Outcomes (10)

• exercise pulmonary arterial pressure

  mean pulmonary arterial pressure (mmHg)

  1 day

• exercise cardiac output

  cardiac output (l/min);

  1 day

• exercise pulmonary wedge pressure

  pulmonary arterial wedge pressure (mmHg)

  1 day

• exercise arterial elastance

  arterial elastance (mmHg/mL)

  1 day

• exercise end-systolic elastance

  end-systolic elastance (mmHg/mL)

  1 day

• exercise mean right atrial pressure

  mean right atrial pressure (mmHg)

  1 day

• exercise right atrial function

  right atrial strain (%)

  1 day

• exercise right volume

  right ventricular volume (ml)

  1 day

• exercise right ventriculare function

  right ventricular strain (%)

  1 day

• exercise right atrial volume-pressure curves

  atrial volume to pressure ratio (ml/mmHg)

  1 day

Secondary Outcomes (4)

• exercise lung congestion

  1 day

• exercise left atrial function

  1 day

• exercise left atrial volume

  1 day

• exercise hepatic backflow

  1 day

Study Arms (4)

Pulmonary arterial hypertension

Patients with mean pulmonary arterial pressure above 25 mmHg, and a pulmonary capillary wedge pressure below 15 mmHg classified into group 1 of the clinical classification of pulmonary hypertension.

Other: Exercise

Pulmonary hypertension due to left heart disease

Patients with mean pulmonary arterial pressure above 25 mmHg, and a pulmonary capillary wedge pressure above 15 mmHg with left heart disease, classified into group 2 of the clinical classification of pulmonary hypertension.

Other: Exercise

Chronic thromboembolic pulmonary hypertension

Patients with mean pulmonary arterial pressure above 25 mmHg, and a pulmonary capillary wedge pressure below 15 mmHg with a history of pulmonary embolism, classified into group 4 of the clinical classification of pulmonary hypertension.

Other: Exercise

Control

Patients with mean pulmonary arterial pressure below 25 mmHg, and a pulmonary capillary wedge pressure below 15 mmHg with exclusion of pulmonary hypertension.

Other: Exercise

Interventions

Exercise OTHER

After placement of the right heart catheter patients will undergo an exercise challenge in semi-supine position until exhaustion

Chronic thromboembolic pulmonary hypertension; Control; Pulmonary arterial hypertension; Pulmonary hypertension due to left heart disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Confirmed diagnosis of either pulmonary arterial hypertension; pulmonary hypertension due to left heat disease; chronic thromboembolic pulmonary hypertension; or invasive exclusion of pulmonary hypertension (control group)

You may qualify if:

• Confirmed diagnosis of pulmonary arterial hypertension (World Health Organization group 1)
• Pulmonary hypertension due to left heart disease (World Health Organization group 2)
• Chronic thromboembolic pulmonary hypertension (World Health Organization group 4)
• Age ≥ 18 years
• Planned right heart catheterization based on clinical grounds
• Stable specific PAH medications
• Ability to undergo cycle ergometry
• Signed informed consent

You may not qualify if:

• Other etiologic groups of pulmonary hypertension (World Health Organization group 3, 5)
• Unstable or severe coronary artery disease
• Uncontrolled arterial hypertension
• Left ventricular ejection fraction \< 30%
• Severe congenital or acquired valvular or myocardial disease
• Progressive left heart failure
• History of severe ventricular arrhythmias
• Severe, terminal renal impairment
• Severe obstructive or restrictive lung disease
• Severe lung emphysema or interstitial lung disease

Sponsors & Collaborators

• University of Giessen: lead

Study Sites (2)

Kerckhoff-Klinik

Bad Nauheim, Hesse, Germany

Location

University of Giessen

Giessen, Hesse, 35390, Germany

Location

Related Publications (2)

• Yogeswaran A, da Rocha BB, Rako ZA, Kaufmann SJ, Schafer S, Kremer N, Ghofrani HA, Seeger W, Tello K. Physiological mechanisms behind respiratory variations in right atrial pressure in pulmonary hypertension. Sci Rep. 2024 May 31;14(1):12547. doi: 10.1038/s41598-024-61825-6.

  PMID: 38822042 DERIVED

• Rako ZA, Yogeswaran A, Lakatos BK, Fabian A, Yildiz S, da Rocha BB, Vadasz I, Ghofrani HA, Seeger W, Gall H, Kremer NC, Richter MJ, Bauer P, Tedford RJ, Naeije R, Kovacs A, Tello K. Clinical and functional relevance of right ventricular contraction patterns in pulmonary hypertension. J Heart Lung Transplant. 2023 Nov;42(11):1518-1528. doi: 10.1016/j.healun.2023.07.004. Epub 2023 Jul 13.

  PMID: 37451352 DERIVED

MeSH Terms

Conditions

Hypertension, Pulmonary; Pulmonary Arterial Hypertension; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Richter J Manuel, MD

  UKGM Giessen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2020
• First Posted: December 10, 2020
• Study Start: November 1, 2020
• Primary Completion: November 4, 2022
• Study Completion: November 4, 2023
• Last Updated: May 17, 2024

Record last verified: 2024-05

Locations

DE (2)